Pfizer Kalamazoo Contractor Manual – Version 2.0 – Last ...kalamazoocontractoradministration.pfizer.com/Files/Contractor... · Pfizer Kalamazoo Contractor Manual ... **In Case

Pfizer Kalamazoo Contractor Manual – Version 2.0 – Last Revision Date: 08/23/10

**In Case of Emergency Dial 1-2-3 on a Company Phone or 269-833-4799 on a Cell Phone** 1

CONTRACTOR MANUAL PFIZER KALAMAZOO SITES



1.0 Introduction ............................................................................................................................................................... 3 2.0 Pfizer Resources/Contact Information .................................................................................................................... 4 3.0 Site Access .................................................................................................................................................................. 6 4.0 Procurement............................................................................................................................................................... 8 5.0 Security ....................................................................................................................................................................... 9 6.0 Emergency Procedures............................................................................................................................................ 12 7.0 GMP/GLP................................................................................................................................................................. 20 8.0 General Work Information..................................................................................................................................... 22 9.0 Supplier Non-Compliance Process......................................................................................................................... 24 10.0 Environment, Health & Safety Topics................................................................................................................... 26 11.0 Site Permitting ......................................................................................................................................................... 36 12.0 Basic Safety Requirements...................................................................................................................................... 40



1.0 Introduction

Welcome to the Pfizer Kalamazoo Sites. Pfizer seeks to engage suppliers that are dedicated each day to maintaining an accident-free work place. Safety is our #1 concern. There is never an acceptable reason for compromising safety. The following document has been prepared for Suppliers, their sub-suppliers, visitors and delivery persons servicing the Pfizer Kalamazoo sites. It is very important that contractor work is conducted in a safe and environmentally sound manner. This manual is intended to be a breakdown to sort out the site policies so that contractors can determine if a policy or program applies to their particular work. Suppliers will still be responsible for assuring that all applicable programs and policies are followed.

Suppliers shall ensure that all contractors have reviewed the sections of this document that are applicable to the work they perform. This document does not relieve the Supplier of their responsibilities to comply with all applicable federal, local, state regulations, laws, ordinances, or statutes.

Pharmaceutical research and manufacturing operations are potentially hazardous. Throughout

our sites, Pfizer engages in a broad range of activities. Many of these activities involve the use of known hazardous, flammable, or toxic chemicals, and/or drug compounds, each with its own set of hazards and risks. Contractors must be aware that numerous hazards exist throughout our sites, and that the hazards vary widely from lab bench to lab bench, floor to floor, building to building and project to project.

It is important to remember that whether working at an active production facility, in a research laboratory, or even an office, it is every contractor’s responsibility to seek out and understand workplace safety precautions, and to take those actions that will allow them to work safely in their assigned work areas. Each contractor’s individual responsibility is to exercise educated, sound judgment and use his/her own experience and expertise to incorporate Environment Health & Safety considerations into everything they do.

Pfizer is committed to achieving full compliance with all federal, state, and local regulations, as

well as Pfizer Corporate guidelines. These guidelines apply to all Pfizer suppliers. In addition, Contractors must also be aware of emergency procedures and contact information

contained in the Emergency Procedures Handbook Kalamazoo. 1.1 Pfizer Representative - The Pfizer Representative is a Pfizer employee who, through appropriate

delegation of authority, is operationally administering the business agreement (contract) with an outside firm or independent contractor for specified services or results. The Pfizer Contact will be the ongoing liaison should questions/issues arise.

1.2 Contractor – A contractor is an individual employed by a Supplier to perform a specified

services within Pfizer to support business operations, specific projects or tasks. 1.3 Contractor Safety Representative - An individual assigned by the Contractor who is

responsible for the Contractor’s safety program and performance. This person has the responsibility, power, and authority to stop his/her company’s work when and where unsafe activities or conditions exist. To qualify, as a Contractor Safety Representative the individual



must have completed, at a minimum, an OSHA approved 30 Hour General Construction Safety Course and five years construction experience.

1.4 Sub-Supplier - A Supplier or his/her employee(s), whose contract is subsidiary to a prime

contract between Pfizer and a Supplier.

1.5 Supplier - A supplier is a non-Pfizer business entity (including independent contractors) under contract to provide individuals to perform specified services or results on a temporary or long-term basis. The firm will be responsible for the performance and status of its workers as well as any and all employer related obligations, regulations and laws.

1.6 Visitor - Individual who is on site for less than 5 consecutive days, has not attended a Site

Orientation Training within the past year, and is escorted and supervised 100% of the time while at a Pfizer facility by a badged Contractor, or a Pfizer employee.

2.0 Pfizer Resources/Contact Information

2.1 Badging Information (Gateway)

Kalamazoo Contractor Administration: KCA Help Line: 269-833-7048 Fax: 269-833-2500 KCA email: [email protected] KCA website: http://kalamazoocontractoradministration.pfizer.com/Kalamazoo.htm

2.2 Contractor Safety

Contractor Safety Staff

269-833-7048 KCA Hotline 269-833-7283 Sr. Construction Safety and Compliance Professional - Training,

Maintenance & Services 269-833-0516 Sr. Construction Safety and Compliance Professional - Capital Projects

& Services for VMRD (Downtown and Farm) 269-833-0798 Sr. Construction Safety and Compliance Professional - Capital Projects

Portage Site 269-833-6120 Sr. Contractor Management Professional - Pre-Qualification, Sub-

Supplier Approvals & Incident Data 2.3 Contractor Types

New Contractor Types: (Allow up to 4 business days to process this request.) • Outsourced • Professional/Technical • Temporary



2.4 Visitor Badge Types:

A normal visitor badge can be obtained for company employees coming on site for meetings, etc. The request for a visitor badge must be made by a Pfizer colleague through the IVisitor system. Visitors must be escorted 100% of the time.

2.5 New Contractor On-boarding Process

Prior to any contractor receiving a Pfizer issued access badge, the supplier or individual that the contractor is employed by must be qualified according to criteria set forth by Pfizer Procurement. These criteria are considered outside the scope of this policy. A signed approved contract between the supplier that is to supply contract personnel (contractor) and Pfizer must exist before a Contractor badge is issued and subsequent site access is granted. An approved Purchase Order (PO) is not a contract. Prior to any sub-supplier receiving a Pfizer issued access badge, the supplier who is subcontracting the work to the supplier (and its employees) or individuals must complete Sub-Supplier Qualification information to the contractor safety group for Sub-Supplier approval. Sub-Supplier Qualification documents are located on the KCA websites.

2.6 Existing Contractor Off-boarding Process

The supplier responsible for the contractor must use the Supplier Gateway system to notify the contingent workforce coordinator of termination of a contractor. A Pfizer representative may also notify the contingent workforce coordinator via e-mail at [email protected]. The Pfizer representative, or supplier responsible must also ensure the following assets/materials are returned in a timely manner to the appropriate area. Contractor ID badge—Return to security Contractor parking permit—Return to security Pfizer owned keys—Return to security Pfizer owned telecommunication devices such as radios, pagers or cell phone—Return to communications group Pfizer owned uniforms or other garments—Return to laundry Pfizer LAN ID and password—Automatically deactivated when contractor is off-boarded

2.7 Existing Contractor Badge Renewal

Renewal Requirements All Kalamazoo Pfizer Contractor Worker (CW) badges are valid for a maximum of one year from date of issue. If the contractor’s services are no longer needed, or they have been terminated by the hiring supplier, the Pfizer off boarding procedures will be initiated via the Supplier Gateway, and all Pfizer property in the contractor’s possession will be retrieved, according to established Pfizer procedures.



2.8 Extension of End Date

All Pfizer Sponsors that are responsible for contractors shall extend their contractors end dates according to the length of services needed.

2.9 New Contractor Badge Types: (Allow up to 7 business days to process this request.)

CMU – Construction, Maintenance, Utilities DEL – Delivery OSW – Outsourced Service PTS – Professional/Technical Services PTW – Project Temporary Worker SEC – Security TCW – Temporary Contract Worker

2.10 Quarterly Renewal

All Pfizer Sponsors are also responsible for performing quarterly renewal of all contractors.

2.11 Substance Abuse and Background Check Requirements / Contingent Worker #117

Pre-assignment drug testing, background, criminal and debarment checks are mandatory for all new contingent workers, contractors, and suppliers who perform work for Pfizer. Conducting tests and screening is the responsibility of the individual supplier, and is subject to periodic audit by Pfizer. This is part of the Contingent Worker Procedure #117, If there are any questions, please contact your Pfizer Procurement Specialist.

3.0 Site Access

3.1 Contractor Responsibilities Regarding Sub-Suppliers

A Sub-Supplier is defined as any agent, representative, consultant, advisor or other third party employed or used by the Contractor in the performance of the Work. Sub-Suppliers are to be pre-qualified according to Pfizer Standards, by the Kalamazoo Contractor Administration group, prior to site access being granted. The Sub-Supplier representative must complete the Sub-Supplier Prequalification Form (available on the KCA website below). The information contained in the form must be reviewed and approved by the requesting supplier representative, approved, and submitted to KCA for final approval. Prime contractors that use Sub-Suppliers shall be responsible for the Sub-Supplier’s adherence to all the Pfizer requirements, which are contained in the Qualification Form. The Kalamazoo Sub-Supplier Qualification Form is available on the Pfizer Kalamazoo Contractor webpage: http://kalamazoocontractoradministration.pfizer.com/Forms_Manuals_Instructions.htm



3.2 General Information

Any person entering a Kalamazoo location is required to receive some type of orientation. The type of orientation received will depend on the classification of the visit. The visit classification and its associated type of orientation are as follows: A Contractor on site for more than 5 workings days in a year, either a planned or un-planned scenario, will complete the New Contractor Site Orientation Test. A Contractor on site for less than 5 workings days in a year will receive a Compliance Information for Visitors Brochure. If the Contractor anticipates multiple visits during a calendar year, for any reason, they must complete the New Contractor Site Orientation Test. Fire, EMS or Police personnel, while performing official functions or in case of an emergency, will require no training for access to the Kalamazoo site. A Routine Delivery person will receive the Site Orientation Training. A Non-routine Delivery person will receive a Delivery Driver Safety card. A Visitor who anticipates less than 5 visits per year will receive a Compliance Information for Visitors Brochure. A Visitor who anticipates more than 5 visits during a calendar year, for any reason, will then be considered a Contractor and complete the New Contractor Site Orientation Test. Special Circumstance Worker (SCW) - A non-colleague who’s Site Access is requested to perform setup, troubleshooting, or consultant work and/or a service contract for a purchased instrument or equipment. This may also include an individual who possess the expertise necessary to perform specialty “work” at a Pfizer facility in Kalamazoo County. A person using a SCV is expected to only be on site short term, where a new contractor badge would be impractical. This person must also be escorted 100% of the time. Special Circumstance Worker (SCW) can only be requested by a Pfizer employee. A Regulatory Agency Inspector will receive a Compliance Information for Visitors Brochure and must be escorted 100% of the time.

The Orientation Test includes basic information on GMP, facility safety practices, emergency response procedures, and hazard communication and Pfizer’s expectations for conducting business in a safe manner. The Contractor Site Orientation Test is a True/False and multiple choice test and uses the Orientation Guide for Contract Workers as reference material. This test may not be taken more than 3 times initially. If the test is failed 3 times, a time frame of 6 months must pass before taking the test again, unless special considerations are in place. Once the contractor successfully completes the New Contractor Site Orientation Test, the contractor will be issued a badge.



All Site Orientation training is provided in English only. The badges are the property of Pfizer Plant Security and must be returned to Plant Security upon completion of the job or when the contractor no longer works at the site. Any lost badges must be reported to the supplier representative or Pfizer Representative, who is responsible for notifying Security and obtaining a new Contract Access Badge. Area Specific Gowning Requirements There are numerous areas throughout the Kalamazoo Site that have specific gowning requirements. The gowning requirements are clearly marked at all entry points to those areas. Questions regarding area specific gowning requirements should be referred to the Pfizer colleague who acts as the contractor sponsor.

4.0 Procurement

4.1 Qualification Requirements

1. All new suppliers of services must be qualified prior to commencing work. The supplier qualification process ensures that suppliers are capable of meeting commitments; can satisfactorily comply with Pfizer’s technical, delivery, service, quality and safety requirements; and are financially secure.

2. Suppliers of non-critical goods or services, where there is a very low risk of damage to Pfizer property or financial loss, may be qualified at the discretion of the Requestor.

3. Procurement is responsible for ensuring that suppliers of materials and services have been properly evaluated and qualified in advance of the purchase transaction. The Supplier Pre-Qualification system enlists the support of Finance and Safety. The Supplier Pre-Qualification system is the repository for all pre-qualification documents and supplier qualification status.

4.2 Qualification Process – Supplier of Services

1. The supplier must complete the Pfizer Pre-Qualification System data and submit for approval.

2. Once the Supplier has submitted the form, the Pre-Qualification system will complete an automatic review of the Supplier's responses compared to Pfizer’s acceptable criteria. Any exceptions from Pfizer acceptable criteria will be forwarded to the functional approver (Finance or EHS). Written justification and approval will be required for all exceptions. If all issues have been resolved, Procurement can process the final request and update the supplier status.

4.3 Pfizer Acceptable Criteria

1. Finance: Pfizer On-Ramp Supplier Report from D&B must have a score that is not considered “high risk.”

2. EHS: a. Three-year Experience Modification Rate (EMR) average should be at or below 1.0.



b. Three-year average of OSHA TRR should be at or below industry average for supplier’s NAICS code.

c. Three-year average of OSHA LWR should be at or below industry average for supplier’s NAICS code.

d. Person responsible for Safety is clearly identified. e. No willful or repeat OSHA Citations within last three years. f. Written safety program is available for review.

2. Insurance: Procurement verifies that acceptable Pfizer limits are met for type of work and that a current Certificate of Insurance (COI) is attached to the Pre-Qualification system.

3. Periodic Review a. Financial reports are required to be updated annually. b. EHS data is updated annually – the EMR upon expiration and OSHA rates must be

updated in the Pre-Qualification system after the calendar year, within the OSHA 300A posting deadline of February 1st of the next year.

c. Insurance certificates must be updated annually prior to expiration.\ 4. Non-Qualified

a. The supplier may be removed from the Pre-Qualified status if they repeatedly do not meet Pfizer’s requirements. The affected areas and Procurement will make this decision jointly.

5.0 Security

5.1 Weapons and Firearms

5.2 Coverage

This policy applies to all employees. This policy also applies to others who conduct business with or on behalf of Pfizer including but not limited to agency or contract personnel, consultants, vendors, and customers.

5.3 Policy

Pfizer is committed to providing a safe work environment. Compliance with this Policy requires that all individuals on Company premises, in Company vehicles, conducting business with or on behalf of Pfizer, or otherwise representing Pfizer not be in the possession of firearms or other weapons. The term “weapon” refers to any firearm or other instrument that could cause death or serious bodily harm, or that could place one in fear of death or bodily harm.

Any violation of this Policy may result in disciplinary action up to and including termination of employment, loss of access privileges, termination of the services of a consultant, customer, vendor, contractor and/or their associated firm, or other action the Company deems necessary including referral of such violations to appropriate law enforcement authorities.

5.4 Exceptions

There is an exception for Law Enforcement officials, and security personnel who have been granted written authorization by the Vice President of Global Security to possess a firearm or other weapon.



There is an exception for participation in business related sporting events that involve the use of firearms or other weapons. Employees may participate, (but can not be required to participate), if such participation has been authorized in advance by site management or senior division management. In addition, where the sporting event is sponsored by Pfizer, employees must comply with all other applicable Pfizer policies, such as the Global Policy on Interactions with Health Care Professionals, in inviting guests and must obtain in advance from their guests a signed form of release satisfactory to the Legal Division or Corporate Human Resources. In all cases, the consumption of alcoholic beverages before or while using a firearm or other weapon is prohibited and there must be strict compliance with all applicable firearms laws and safety requirements. Firearms or other weapons may be transported in Company vehicles only for the limited purpose of going directly to and from such sporting events.

5.5 Reporting Procedure

All employees and others covered under this policy are responsible for establishing and maintaining a safe work environment that promotes professionalism and is free of threats and violence. This responsibility includes being alert to situations in which firearms or other weapons may be present in violation of this Policy, and in good faith immediately notifying appropriate Company personnel of any incidents or concerns. Therefore, the Company expects you to notify your Supervisor, Human Resources representative, or Site Security Officer of any such concern. In cases where there is a threat of immediate harm, the report should be made to the Site Security Officer.

All reports will be taken seriously. The Company will initiate appropriate action based on the circumstances, and consistent with applicable privacy and other laws. The company will take all reasonable steps to address the safety concerns of those who have reported or believe that hey may have been subject to workplace violence, or are otherwise concerned about their safety or security.

5.6 Prohibited Activities Any contractor may be removed from the premises immediately, and their employer informed, when there is reasonable cause to believe that gross misconduct has been committed, during the course of work being performed on Pfizer property. These activities include but are not limited to the following: − Insubordination − Theft − Dishonesty − Time reporting fraud − Disclosure or inappropriate use of confidential information − Negligence − Fighting, horseplay, or disruptive behavior − Gambling or playing games for money. − Possession of weapons, firearms, ammunition or incendiary devices − Inappropriate possession, consumption, sale, or use of alcohol − Inappropriate possession, consumption, sale, or use of illegal substances − Inappropriate possession, consumption, sale, or use of controlled substances



− Willful mishandling of a controlled substance − Inappropriate use of E-mail or Internet If a contractor observes inappropriate behavior, the matter should be reported to their immediate supervisor. The immediate supervisor for the contractor will then report the matter to the Pfizer representative. If the behavior is an immediate threat to the health and well being of colleagues or contractors, the matter should be reported to Pfizer Security immediately. If Pfizer Security can corroborate the behavior and determines the behavior necessitates removal of the individual, the supplier responsible for the individual, and the Pfizer sponsor of the contractor, will be notified to facilitate the removal of the individual. In addition, all internal documents that a Pfizer contractor may come in contact with are the intellectual property of Pfizer. They may not be removed from the site without the written permission of the Kalamazoo Site Lead. Contractors are prohibited from duplicating, destroying or copying records.

5.7 Cameras and Video Recorders

POLICY: The use of still or video cameras at the Site is restricted. For the purpose of this policy, devices such as PDAs and cell phones, which have digital photography capabilities, are considered cameras. Pfizer camera users (or the Pfizer hosts of visitors with authorized cameras) are responsible for complying with this policy. The following restrictions apply: Individual Authorization – photography that includes people (i.e. a Pfizer colleague, contractor, intern groups, etc.) are permitted only with the permission of the individual(s) being photographed. Sensitive Information – no photography is permitted involving sensitive company processes or private company information without specific written authorization from the appropriate management representative(s). Examples include, but are not limited to: Vivaria, Lab Areas, Research and Development data, operation and testing processes, chemical processes, regulatory information, pharmaceutical operations, company plans, white boards, emergency situations, photographing of printed documents, and executive offices.

5.8 Camera Procedure/Process:

Persons requesting temporary permission to use camera equipment will complete a Camera Use Approval form and route for appropriate endorsement. The completed form will be routed to the appropriate Security, Leadership, Operations, and/or Public Affairs representative (see “Form Routing” on the attached Briefing Form), prior to the camera being brought onto the Site premises. Cameras which are brought onto the Site premises without approval are subject to confiscation.



Visitors may not bring cameras onto the Site unless the stated purpose of their visit is to take business related photos at Pfizer’s request. Any non-colleague taking photos must be escorted by a Site colleague, regardless of badge status. The security representative may revoke permission to use cameras in any case where photography might cause sensitive information to be compromised. Colleague should carry a printed copy of the approval from.

5.9 Cell Phones, Personal Electronic Devices, Pagers Pagers and cell phones for business purposes may be allowed with the prior approval by the Pfizer responsible, on a case-by-case basis. Only UL listed, intrinsically safe cell phones and pagers that are rated for use in hazardous locations (a.k.a. explosion proof) are allowed in production and warehousing areas and must be logged by contractor safety. Personal electronic devices, such as: Personal Digital Assistants (PDA’s – a.k.a. Palm Pilots), portable CD/ DVD/ MP3 players, or similar devices are prohibited from all pharmaceutical production and warehousing areas, where they represent a potential ignition source due to their non-explosion proof design.

5.10 Vehicles Only designated site roads and gates are to be used for entry or exit.

Contractor on site parking shall be prohibited except for company decaled vehicles.

Unauthorized vehicles parked on site or vehicles parked in areas other than assigned will be towed. Vehicle damage, towing and storage charges will be the vehicle owner’s responsibility. Vehicles parked or operated on site are subject to search without prior notice. Failure to permit a search shall result in the vehicle and employee being barred from the site.

Reckless and/or irresponsible vehicle or machinery operation shall result in punitive measures deemed appropriate by the owner.

6.0 Emergency Procedures

Purpose – Outline requirements for emergency situations Requirements – (See also “Emergency Procedures Handbook – Kalamazoo”) • In the event of any emergency (fire, medical, injuries,), dial 123 from an internal telephone or

269-833-4799 from a cell phone or other outside phone. This phone is available 24/7. • Non-emergency spills and releases must be immediately reported to 269-833-3800. This phone

is available 24/7. A spill is the unintentional release of any material



• Notify the Pfizer representative after reporting the emergency or spill for follow-up and investigations.

• Contractors must be aware of Pfizer alarm systems including bells, PA, and alarms. The systems have different designations for medical, fire or other emergencies.

• Contractors must be aware of evacuation assembly locations. • Contractors must be aware of tornado shelters according to maps located in working areas. • Contractors must be aware of safety showers, eye wash stations, fire alarm boxes, fire

extinguishers and other emergency equipment locations in their work areas. Applicability – • Applies to all contractors. Site-Specific Training requirements • New Contractor Orientation and Annual Refresher Tests. • No additional site specific training required. References – • Pfizer Emergency Procedures Handbook Kalamazoo • 26971 Emergency Shower and Eyewash Testing, Inspection and Use

6.1 Building Emergency Maps Building Emergency Maps are located in occupied buildings throughout the Pfizer Kalamazoo Site. These maps contain information in regards to emergency guidelines, emergency phone number, and tornado shelter location.

6.2 Safety during an emergency

In an emergency, Security Officers have the latest information available from the Site Dispatch Center and are in radio contact with emergency responders. Security Officers are in the best position to direct you to safety and protect our resources. When an emergency is declared, following the directions of Security Officers becomes critical to your safety and the safety of others. When a building evacuation is announced: Do walk to your shelter Do take your security badge and personal belongings if readily available Do escort your guest with you to the shelter Do use the stairways Do not use the elevators Sirens tested on the first Saturday of every month, (1:00 PM) at all 3 sites Emergencies can happen at any time. Please be sure to obey parking signs and directions, being especially careful no to block fire lanes or other marked emergency access points.



6.3 Emergency Numbers

Fire Injury /Medical Explosion Haz-mat Bomb threat Mail threat

Dial 123

269-833-4799

Non-Emergency Spills/Releases (Solid, liquid or gas) (269) 833-3800

6.4 Contact Phone Numbers

Security (269) 833-3636 Fire Station/Non Emergency (269) 833-5122 Emergency Planner (269) 833-8351 Health and Wellness (269) 833-9291

6.5 General Guidelines

When to make an emergency call Each of us is responsible for reporting an emergency. Following this simple guide of instructions will ensure that emergencies are reported accurately and that effective action can be taken. Please remain calm and speak clearly so that the dispatcher can understand you. Let the dispatcher guide the conversation. He or she will need specific information so be prepared to provide the following details: Your name and the telephone number you are calling from The building number, floor number and exact room location if known. Type of emergency you are reporting (fire, injury, security emergency) Any other helpful information. The dispatcher will let you know when all of the information is recorded and will give you instructions about the next steps. Do not hang up until told to do so. Notify your Pfizer contact as soon as possible.

6.6 Injury/Medical Response Procedures

All incidences are potentially serious, it is Pfizer policy that all injuries and chemical exposures should be promptly reported and investigated. Contractor injuries are to be reported immediately to your supervisor, Pfizer Contractor Safety and Pfizer contact. Suppliers are required to complete a Kalamazoo Site “Contractor Incident Investigation Report” and submit the form to the appropriate “Contractor Safety”. The form is available on the KCA website.



http://kalamazoocontractoradministration.pfizer.com/Forms_Manuals_Instructions.htm Select the “Incident Report Form” from the list. Instructions for Form submission are printed on the form. An emergency medical issue, such as those issues requiring ambulance transport, should be reported first to 123. Non-emergency injuries can be handled via the supplier designated medical provider. If there is any doubt as to the severity of an injury ALWAYS call 123. Contractors should not call 911 for ambulance service. All ambulance requests should go through 123 or (269) 833-4799 by cell phone.

6.7 Fire Response Procedures

Preparation Know the location of your building egress routes, exits and fire alarms. Refer to posted emergency maps located throughout the building. Know the location of your Evacuation Assembly Area. Response If you discover smoke or a fire in your work area: Dial 123 or (269) 833-4799 to report the fire immediately Activate the nearest fire alarm Secure ongoing process (if safe to do so) Ensure all people are proceeding to their Evacuation Assembly Area Evacuation Assembly Areas - See section titled “Evacuation Procedures” Pfizer Unit Leads to verify that their work areas have been swept and no known personnel are still in the affected area. If you know a person is down or still in the building, report directly to the Incident Commander at the scene. If you have critical information related to the fire or the facility, report directly to the Incident Commander at the scene. Once at the Evacuation Assembly Area: Contractor Foreman or Superintendant leads shall account for everyone in their unit Await further instructions from the Pfizer Incident Command everyone shall remain in the evacuation area until directed. Do not re-enter the work area until all-clear is given



Other Tips Only authorized personnel shall use fire hoses and breathing apparatus If you are caught in a fire, always crawl along the floor to minimize the effects of inhaling smoke or other fumes If your clothes catch on fire, do not run. Stop where you are, drop to the ground and roll over and over until the flames are smothered If you are disabled, ensure that plans have been made for your safe evacuation and the Fire Station knows your work location. Some buildings have designated areas (area of refuge) where people who are unable to use the stairs can wait for assistance.

6.8 Tornado Sheltering Procedures

Preparation

Know the location of your Tornado Shelter ahead of time. Shelters are assigned for each site building – refer to the posted building emergency maps. When visiting another building, refer to that building’s emergency maps for the assigned tornado shelter. Response

o Tornado Watch ( Issued by the National Weather Service (NWS) for Kalamazoo County)

− Notification – PA announcement

− Be sure everyone in your area is aware of the announcement and establish direct radio communications with essential plant operators

− Do not start any new processes

− Be prepared to secure on-going processes

− Management should identify essential plant operations (See Tornado Warning below)

− Stand by for further instructions

o Tornado Warning ( Issued by the National Weather Service (NWS) for Kalamazoo County)

− Notification – PA announcement, Pfizer outdoor emergency warning siren*, strobe lights and auto-call bells where available.

− Secure any on-going processes

− Proceed immediately to your primary tornado shelter

− Unit leads to verify that their work areas have been swept and no known personnel are still in the building. Exception: Essential Plant Operations



− Essential Plant Operators should stay at their work stations and stand by for further PA or company radio announcements.

− Do not go your locker room or change clothes

− If you are disabled, ensure that plans have been made for your safe evacuation to your tornado shelter

o Take Cover (Site Specific threat)

− Notification – one or more of the following:

− PA announcement, outdoor emergency warning siren, company radio or other means

− All personnel (including essential plant operators) should go immediately to the nearest tornado shelter (for Portage East – this may be a secondary shelter)

− See shelter maps in Emergency Procedures Handbook Kalamazoo

− Exception: If you do not have time to reach a primary or secondary shelter, go directly to an enclosed windowless area at the lowest level of your building, such as a stairwell or internal room/restroom. Crouch down and cover your head.

o Once at the Tornado Shelter

− If you know a person is down or still in your building, call Central dispatch (123) or (269) 833-4799

− Await further instructions from Pfizer Incident Command − Do not leave the shelter until the all-clear is given

Other Tips

Do walk to your shelter Do take your security badge and personal belongings if readily available Do escort your guest with you to the shelter Do use the stairways Do not use the elevators Sirens are tested on the first Saturday of every month, (1:00 PM) at all 3 sites

6.9 Evacuation Procedures

Evacuation of personnel may be necessary for emergencies involving hazardous materials, workplace violence, bomb or mail threats, etc.

Preparation

Know the location of your building egress routes and exits. Refer to posted emergency maps located throughout the building. Know the location of your evacuation Assembly Area



Contractor Foreman or Superintendant should pre-establish unit meeting points/locations within your Evacuation Assembly Area to help account for everyone in your unit. Response Individual Noting the Condition • Take immediate measures for protection from the hazard • Warn others in the affected area • Dial 123 or (269) 833-4799 to report emergency to Central Dispatch • Follow PA instructions and /or auto call bells • Move to your Evacuation Assembly Area if conditions require immediate evacuation

Personnel in Affected Area • Take immediate measures for protection from the hazard • Secure on-going processes (if safe to do so) • Follow PA instructions and /or auto call bells • Move to your Evacuation Assembly Area if conditions require immediate evacuation

Building Evacuation • If a building evacuation order is given, proceed in an upwind direction to your Evacuation

Assembly Area or other location as directed by Central Dispatch or the Incident Commander. Perform a sweep of your work area as you leave to ensure all personnel are evacuating

Evacuation Assembly Areas • The assembly areas are dependent upon the activity itself and the location of that particular

activity. • When on Pfizer’s sites, refer to the posted red emergency maps inside the building for

information pertaining to emergency guidelines.

• Contractor Foreman or Superintendant to verify their work areas have been swept and no known personnel are still in the affected area.

• If you know a person is down or still in the building, report directly to the Incident Commander at the scene.

• If you have critical information related to the incident, or the facility, report directly to the Incident Commander at the scene.

Once at the Evacuation Assembly Area: • Unit leads should account for everyone in their unit • Await further instructions from the Pfizer Incident Command • Do no re-enter the work area until all-clear is given



6.10 Emergency Alarms

Auto-Call Alarms – Portage East 1 Ring All Clear 5 Rings Volunteer Guards 7 Rings Supplied Breathing (Air Emergency) 10 rings and 3 Digit Code (Alarm Box #) Fire 15 rings Chemical Area Only First Aid 20 rings Rapid Tornado Continuous Rings Evacuation

(Note: All auto-call alarms are automatically repeated 4 times)

Strobe Lights – Portage East 2 Flashes plus 6 Flashes Repeats 4x Non-Evacuation (Bomb Threat) 7 Flashes Supplied Breathing (Air Emergency) 10 Flashes and 3 digit code Fire 20 Rapid Flashes Tornado Continuous Flashes Evacuation 3 Flashes and 3 Digit Code Individual Building Evacuations

(Chemical Area Only)

Strobe Lights – Downtown/Richland (where available) Continuous Flashes Fire, Evacuation

Pfizer Outdoor Siren Portage Animal Health Tornado Warning Downtown Tornado Warning The siren downtown is controlled by the City of Kalamazoo

6.11 Emergency Response Guide

Refer to posted Emergency Response Guides at laboratory entrance and other select locations for guidance in responding to radiation, chemical and biological spills.

6.12 Safety Equipment

All Pfizer units have specific guidelines governing the use of safety showers, eye wash stations, fire alarm boxes and fire extinguishers. Contractors should familiarize themselves with the location and use of these types of safety equipment.



7.0 GMP/GLP

7.1 Good Manufacturing Practices (GMP) – GMP, also known as cGMP, stands for Good Manufacturing Practice, and is a set of regulations set forth by the U.S Food and Drug Administration to help ensure that various products intended for human consumption and use are safe and effective. GMP regulations mandate a quality-related methodology to manufacturing, enabling businesses to minimize product contamination, mislabeling and other errors. This protects the consumer from purchasing a product that may be effective or even dangerous. Most of the GMP regulations primarily address issues such as sanitation, process validation, equipment and document traceability, and personnel qualification. Failure of suppliers to comply with GMP regulations can result in product recall or seizure, fines and prison.

7.2 Hygiene Practices of Contractors

It is expected that contractors will practice good personal hygiene and wear clean clothing that is appropriate for the job and the work area. In some restricted manufacturing areas, and/or research areas, contractors are expected to wear hairnets, beard covers, shoe covers, and tyvek suits covering your clothing. Cosmetics, artificial nails, jewelry, watches or wedding rings with stones may not be allowed in certain areas. Be sure to follow the specific policies and SOPs for the area you will be working in. All contractors must report wounds and illnesses to their Pfizer Contact. Open lesions can impact product quality in areas with restricted access and controlled environments.

7.3 The Importance of Training

The Code of Federal Regulations states the each person who works in a GMP facility shall have the education, training and experience to enable him to perform his assigned job function. Training will focus on the particular operations that the employee performs and include current Good Manufacturing Practices related to their job function. Therefore, contractors must take the training you are provided seriously. The Pfizer contact is responsible to assure that contractors receive the proper on-the-job training or work site training to perform the work contracted in accordance with GMP’s or GLP’s related to your job function. A positive attitude toward training is important. When contractors are actively involved in training sessions and apply the training on the job as required, Pfizer can be assured the task will be completed safely and efficiently.

Upon completion of classroom style training contractors are required to print name, sign and date and name your supplier on a Training Sign-in Sheet. The Training Sign-in Sheet provides Pfizer



and the Food and Drug Administration with documentation of the required training. Contractors may also be asked to document other Pfizer specific on-the-job training by signing other types of training documentation forms.

Wood ladders/wooden hand tools are not allowed on site unless pre-approved by Pfizer

7.4 The Importance of Documentation

The Code of Federal Regulations states that if you didn’t document it, you didn’t do the work, or take the training session. GMP and GLP regulations require that we document our work. As a contractor or service provider, your work, or training, is documented by you printing your name, providing your signature, list the date of the work you performed and the name of the employer you work for. When documenting these things do the following:

Write clearly and use black ink only. When making entries into work logs, do it immediately after the work activity occurs. Fill in all blanks required; do not leave blank lines. Write N/A if needed. Line out mistakes or incorrect entries, write the corrected information, write your initials next to the corrected entry, and the date on which the corrected data was written down. Do not erase, use white out, or cross out the incorrect data to the point where it can’t be recognized as it was originally written.

7.5 Employee and Product Protection

Because people are the biggest source of contamination at Pfizer sites, GMP and GLP regulations include requirements to prevent contamination to our products and processes used to make, hold, test or distribute our drugs. To prevent contamination Pfizer monitors the hygiene practices of people, the flow of people traffic in the site, restricted access in various areas, and housekeeping or cleanliness of the workplace.

7.6 Housekeeping and Cleanliness of the Workplace- physical contamination

Examples of physical contamination are tools or materials that make their way into raw materials or product. Material or foreign objects left in equipment may dissolve in the process and become a chemical contaminant (a tape measure or gasket that dissolves in the process solvent). Product or materials contaminated in this manner may need to be destroyed.

Examples of activities to be aware of to promote Pfizer product safety are: • Tool control: Make sure all of your tools are accounted for when you finish a job. • Certain waste containers are specifically for product waste and can’t be used for general

garbage. Be alert to labels on waste containers. • Teflon tape: Begin applying tape on the second thread and back from the end of the pipe.

Teflon tape should not be exposed or come into contact with drug substances, additives or production processes.

• Pipe dope: Adhere to all Pfizer Piping standards. • Doors and windows must not be propped open under any circumstances, unless approved in

advance by your Pfizer Contact.



Gaskets that come with equipment should be checked with the operating unit to make sure that they are the correct ones. Contractors are held accountable for littering and tool control when it contributes to unsafe or unsanitary housekeeping conditions on the job site.

8.0 General Work Information

8.1 Equipment

Business needs may require contractors to use specialized site-specific equipment and/or facilities provided by Pfizer. Pfizer owned equipment & facilities such as material handling trucks and carts, floor washers, freight elevators, chain and electric hoists, monitoring equipment, fans and blowers etc. may be used by non-Pfizer workers when the following conditions are met:

A principal owner of the supplier agrees to hold Pfizer harmless if contractor workers are injured using the equipment or facilities. (Or attachment to PO / general conditions) The contractor has demonstrated to the Pfizer contact person that the contractor cannot economically provide the equipment and/or facilities. The contractor ensures their workers are properly trained in the safe and environmentally compliant operation of the equipment, or facilities, and that the equipment is operated in a safe and environmentally compliant manner. The contractor provides training and skills testing for their employees. Pfizer personnel may train non-Pfizer worker as the last resort, if no other competent trainer is available. If this occurs, Procurement should be contacted to determine if a more qualified contractor can be obtained. If State or Federal regulations mandate a certification of training, the contractor ensures their employees who operate the equipment have the appropriate credentials. The contractor provides their Pfizer contact person with documentation of each operators training, if it is requested. The equipment must be inspected before each use, and not used if problems are found. All problems and accidents involving the equipment are immediately reported to their Pfizer Responsible person.

8.2 Use of Cafeterias and Snack Bars

Cafeterias and snack bars are open to contractors. Contractors are expected to use the cafeterias and snack bars during regular service hours. Proper attire and a reasonable level of cleanliness are expected while in Pfizer cafeteria and snack bars. Note: No PPE is allowed in Cafeteria areas.



8.3 Use of Restrooms

Contractors are allowed to use Pfizer restrooms however if the cleanliness of the restroom is compromised in any way, other arrangements will be made.

8.4 Tobacco Policy

Smoking and the use of tobacco products are prohibited on Pfizer properties. Violation of this policy may result in immediate removal from Pfizer premises.

8.5 Dress Code

There is no formal dress code for Pfizer contractors, due to the diverse nature of the type of work being performed by different types of contractors. Attire deemed inappropriate by a Pfizer colleague will have the discretion to respond to the situation accordingly.

There are to be no offensive graphics or words of any form on attire worn.

No shorts

Dress should be in good shape without holes.

8.6 Contractors

Providing additional field office security beyond that provided by Owner’s Security Department. Where additional security measures are instituted, advise the Project Safety Manager, Project Engineering and Pfizer Security Management. Providing a list of supervisory personnel (name, address, and telephone number) to their Pfizer contact, who will be available during non-work periods to assist, in the event of a security breach and/or emergency situations. Advising employees, contractors, and suppliers of site speed limits and security measures. Providing identification of all equipment and machinery by paint scheme, I.D. tag or contractor’s name painted in a prominent location. Disabling all motorized machinery, i.e. front-end loaders, backhoes, bulldozers, etc., during non-work hours to prevent unauthorized operation. All deliveries shall enter the property through pre-specified access points and report to the appropriate contractor’s trailer prior to proceeding on site. After hour deliveries must have special permission. Be ready to show your Contractor Badge - We can best protect our site by controlling who has access to it. Security Officers may ask to see your contractor badge when you enter a site, or building. Remember - they are doing their job. A “spot check” means they are checking to see if you are authorized on the site.



Suppliers must provide all necessary equipment to perform their tasks and ensure that it stays in a good working condition and is inspected according to standards and manufacturing recommendations.

Wear your issued Contractor Badge – If you work in an area that is specifically identified as a GMP area, you must wear your badge below the waist. Everyone must always display their contractor badge prominently, and always on an outer garment.

Don’t lend your Contractor Badge to anyone or use an access badge to let others into locked areas – Many areas at Pfizer are protected by automated card access readers. Do not enter these areas unless YOUR access card lets you in. One very important piece of information—using someone else’s contractor badge, or lending yours to someone, WILL result in you being asked to leave the premises.

Lock up your property - Pfizer cannot be responsible for the security of personal items or contractor equipment. If your equipment will be stored on the site overnight, please consult your Pfizer contact concerning an appropriate, secure storage area.

All items are subject to search - In order to protect the site properly, Pfizer reserves the right to inspect all vehicles, packages, bags, and other effects coming into, leaving the site, or while they remain on Company property. Be sure you check with your Pfizer Contact before bringing any questionable items onto the work site.

Report any suspicious activities - Don’t hesitate to report any suspicious activity to Security or to a Pfizer employee. The Security Team would rather respond to a false alarm, than investigate a serious theft or incident.

9.0 Supplier Non-Compliance Process

9.1 Purpose

The purpose of this guideline is to ensure that service providers comply with Kalamazoo Site requirements, procedures and policies as well as applicable federal, state and local regulations. Additionally this guideline will ensure that there is a consistent approach to handling non-compliance to site policies by any service provider performing work on the Kalamazoo Site. The scope of this guideline includes all service providers to the Kalamazoo Site. The guideline addresses actions to be taken with companies not adhering to Pfizer policies and procedures and does not address individuals working for service providers. For the purposes of this guideline, any company under contract to Pfizer will be defined as service provider. Individuals working for service providers will be referred to as contractors. Any requirement for operating on the Kalamazoo Site, whether termed policy, procedure, requirement or governmental regulation, will be considered a “policy” for the purposes of this document.



9.2 Responsibilities PGM Procurement – Kalamazoo PGM Procurement will be responsible for the official notification to any service provider and executing the notification requirements of this guideline. Procurement will attend any and all meetings with service providers to discuss actions taken in regard to this guideline. Pfizer Responsible Compliance Groups – Pfizer responsible compliance groups, which include KCA, Security, Health and Wellness, and any other responsible compliance group, will be responsible for documenting all incidents resulting in violations of policies and provide necessary data to procurement to properly document the incident. Pfizer Sponsor – The Pfizer sponsor is the Pfizer colleague responsible for having the service provider on site and or the business representative who initially helped procurement establish the contract. Once informed, the Pfizer sponsor will be part of all discussions held with the service provider regarding non-compliance with site policies and subsequent actions taken with regard to the non-compliance incident(s) by the service provider.

9.3 Procedure/Process

Violations of site policies may be brought to the attention of the involved service provider by any Pfizer colleague. If the violation is believed to be of a nature to cause serious harm or injury to personnel, the environment, or Pfizer property, work shall be stopped immediately. Violations of lesser magnitude should be brought to the attention of the service provider, Pfizer Responsible Compliance Groups and the Pfizer sponsor. Pfizer Responsible Compliance Groups will document the incident in accordance with this guideline as well as notify the sponsor of the service provider involved. Identified violations must be promptly addressed and corrected. Violations may result in work stoppage (at the Supplier’s cost) and result in loss of current and future work for the supplier. Also note that the individuals involved in any incident/violation may face temporary to permanent removal from the Pfizer site. Pfizer encourages the contract company to take appropriate actions with their employees to ensure that no future violations/non-compliance situations arise. On-going non-compliance with site policies will be handled as outlined below. However, note that Pfizer Responsible Compliance Groups and Procurement can re-assess and increase the severity of the action if deemed necessary. Written notifications will be issued during a meeting with Pfizer Responsible Compliance Groups, Procurement, the supplier and other Pfizer representatives as necessary. The supplier may be required to complete a corrective action plan to ensure that the violation has been adequately addressed.

9.4 Non-compliance Notification Process

Observation – Service Provider Immediate Action If a violation of policy is discovered and brought to the attention of the service provider (management) and immediate (and appropriate) actions are taken with the affected employees, the issue will be documented but the violation will not result in initiation of the process outlined below. Violation of policies resulting in potential for danger to life, the environment of Pfizer property may not be listed as observations.



Non-Compliance Notification Process 1st Violation – A discussion of the violation will be held between PGM Procurement, Pfizer Responsible Compliance Groups, Pfizer Sponsor and the management of the service provider. The discussion will be documented with a copy provided to the service provider. The documentation will stay on file for 90 days or until an additional violation is noted. If Non-compliance issues are considered to be severe, contractor contracts can be terminated at any time. 2nd Violation - A discussion of the violation will be held between PGM Procurement, Pfizer Responsible Compliance Groups, Pfizer Sponsor and the management of the service provider. The service provider will be notified that for a period of 6 months any additional violations of policies or non-compliance situations may result in termination of their contract. The service provider will receive written notification from PGM Procurement. Notification of a second violation may result in lost bidding opportunities as well as lost opportunities for on-going work. 3rd Violation - A discussion of the violation will be held between PGM Procurement, Pfizer Responsible Compliance Groups, Pfizer Sponsor and the management of the service provider. The contract between Kalamazoo PGM and the service provider will be terminated according to the provisions in the contract for a period of not less than 1 year. Reinstatement of the contract will be dependent on the needs of Pfizer.

10.0 Environment, Health & Safety Topics

10.1 Barrier Guidelines

Purpose – Outline requirements for construction related activities to restrict access by other persons than the worker(s) working on the project. Requirements – • Construction sites must be isolated from all non-authorized pedestrians and traffic. Appropriate

information signs, tape and guarding shall be in place to prevent unauthorized access. • The use of barrier tape will ONLY be allowed for activities that will be completed in 4 hours or

less. • The use of barrier tape should only be used where it can be easily supported and installed. • Tape must be maintained at all times. • Once activity is complete, all tape around construction area must be removed. • If the activity being performed does not fall under the above guideline and will take more than

4 hours to complete, than the use of rigid barriers and appropriate signage must be used. • Any exception to this guideline must be approved by a Pfizer CM representative in writing,

before proceeding. • Pfizer has hard barriers for contractors to use and are available on a first come first serve basis. Applicability – • Applies to all building and construction contractors.



Site-Specific Training requirements • None required.

10.2 Compressed Gas Cylinders

Purpose – Outline requirements for storage and transportation of compressed gas cylinders. Requirements – • Cylinders shall be identified with the contract company’s name. • Cylinders shall be stored and transported upright and in a secure position with proper protective

caps. Cylinders must be secured with a restraint (chain or strap) of sufficient strength to prevent overturning of the cylinder.

• Acetylene or oxygen cylinders, or other non-compatible materials are to be stored separately (at least 20' apart) and in well-ventilated areas.

• Propane storage tanks are not to be stored inside a building. Applicability – • Applies to all contractors. Site-Specific Training requirements • None required. References – • 27136 Compressed Gas Cylinder Handling and Storage • MIOSHA Construction Part 7, General Industry Part 69 (Compressed Gas Requirements)

10.3 Confined Space Entry

Purpose– To inform all contractors working on site that Pfizer has a confined space entry program. The purpose of the program is to protect personnel working in a confined space. A confined space has a limited means of egress, may contain a hazardous atmosphere or presents an engulfment hazard. Some examples include: tanks, process vessels, bins, boilers, ducts, silos, pits, excavations and sewers. Requirements – • Contractors must have their employee training records for Lockout/Tagout and Confined Space

Entry available prior to receiving Pfizer Safe Work Permit training and also for auditing purposes.

• Contractors must review work to be done with Pfizer representative to determine if a confined space will be entered and whether or not it is a permit-required space.

• Contractors must comply with MIOSHA General Industry Safety Standard Part 90 and Park 1910.146 requirements, including written program, training and equipment requirements.

• If scope of work includes confined space entry, all contractors involved in this activity must complete Pfizer Safe Work Permit training programs.

• Contractors must check-in with Pfizer operations to ensure that the appropriate equipment lockout procedure is obtained and followed prior to starting work.



• Contractors must not enter the confined space until the appropriate entry permit is filled out completely by all parties.

• Contractors must use a Pfizer issued vapor monitor, if contractors choose to use a non-Pfizer vapor tester for additional monitoring, employees must be adequately trained and assure that the instruments are in good working condition and calibrated.

• Suppliers will have to provide an approved confined space rescue team (CSR) for required entries.

Applicability – • Applies to all building and construction contractors. Site-Specific Training requirements • Safe Work Permit training • Vapor Monitor Tester Train the Trainer • Training records maintained by KCA. References – • 25919 Confined Space Entry • 25922 Safe Work Permit • MIOSHA General Industry Part 90, Construction Part 622

10.4 Electrical Safety

Purpose – To inform all contractors working on site that Pfizer has an electrical safety program.

Requirements – • All permanent and temporary electrical work shall be done in accordance with National Electric

Code (NEC), MIOSHA requirements, and NFPA standards, including 70E. • Contractors shall use ground fault circuit interrupter (GFCI) protection at the source when using

electrical tools/equipment. • Temporary electrical services installed at job sites shall be equipped with GFCI protection. • Electrical equipment inspection is to be done in accordance with manufacturer’s specifications,

or at least quarterly. • Frayed or cut electrical cords, or cords with damaged plugs or missing ground plugs shall be

immediately removed from service, rendered unusable, and removed from the site. Defective tools shall not be stored on site.

• All work on live electrical • Per NFPA 70E, no live electrical work is allowed without prior authorization from Pfizer

Management. • Pfizer reserves the right to confiscate and destroy any defective tool or cord immediately. Applicability – • Applies to all contractors. Site-Specific Training requirements • None required.



References – • MIOSHA Construction Part 17 • NEC • NFPA 70E

10.5 Electrically Classified Areas Purpose – To outline requirements for working in electrically classified areas. Requirements – • Pfizer Kalamazoo sites have areas classified by NFPA as Class I, Division 1, Class I, Division

2, as well as general purpose areas. • Class I, Division 1 or 2 areas contain flammable materials. Therefore, no electric or electronic

device may be brought in unless it either meets the electrical classification (is intrinsically safe and Pfizer approved) or is used with a hot work permit.

• Cell phones, pagers, PDA’s, computers, flashlights, battery-powered tools that are not intrinsically safe cannot be brought into electrically classified areas unless a hot work permit is issued for their use.

• Electrical equipment being installed must meet Underwriters Laboratory (UL)/Factory Mutual (FM) approval for hazardous /electrically classified locations (explosion proof or intrinsically safe).

• Fully trained in the Safe Work Permit process to meet Pfizer requirements Applicability – • Applies to all contractors. Site-Specific Training requirements • None required. References – • NFPA – National Fire Protection Association • Hazardous Area Classification Committee (HACC) • NEC

10.6 Environmental Topics

Purpose – Outline requirements for Contractors regarding Environmental aspects All spills need to be reported to (269) 833-3800 Requirements – • Secondary Spill Containment – Fuel, oil, and other chemicals require in containers with a

capacity of 10 gallons or more require secondary containment and are required to be included in the site’s spill prevention plans. Environmental Compliance and KCA must be notified and authorize all fuel, oil and chemical storage.



10.7 Waste Disposal The Pfizer Contact is responsible for the proper disposal of hazardous and non-hazardous liquid and solid wastes generated as a result of contractor activities. Therefore your Pfizer Contact must be consulted prior to disposal in order to ensure compliance with Pfizer disposal procedures and applicable regulations. In addition, consultation with the Pfizer Environmental Compliance Unit is required to determine proper waste characterization and disposal. All hazardous material that is to be disposed of must have a label that contains the name of the material and placed in a container that is appropriate for the type of material that is to be disposed. If excavation of soils is to be performed, contractors must contact the Pfizer Contact to obtain a signed Excavation Tracking Log Authorization Form. This will ensure that excavated soils are disposed of in a cost-effective and appropriate manner. Proper waste characterization and disposal of hazardous and non-hazardous liquid and solid wastes generated as a result of contractor activities must be discussed with KCA and Environmental Compliance (if necessary) prior to the start of work. Contact Project Manager to ensure compliance with Pfizer disposal procedures and applicable regulations. Contractors are responsible for removing their unused chemical materials from Pfizer property.

10.8 Demolition

Contact Site Environmental Compliance to arrange a pre-demolition/excavation review if work involves demolition and the following activities:

a. Managing Environmental Hazards in Excavation or Demolition Projects b. Mercury Management and Disposal c. Scrap Metal Disposal d. Fluorescent Lighting Tube and Light Bulb Disposal e. Cleaning Laboratory Hoods f. Equipment and Piping Identification Hazard Tag

10.9 Water Compliance

Contact the Site Environmental Compliance Water group regarding water rinses or wastewater streams that will be generated. This is to ensure proper disposal disposition. Do not discharge liquids to any drain without first obtaining documentation and approval. Waste streams that have had solvent contact will require collection for proper disposal. Fugitive Emission Program (needs to be its own section (i.e. not in water) Contractors should be aware of the fugitive equipment tags on valves, pumps, and agitators. If changing piping or piping insulation, retain the fugitive tags from the equipment that is removed or changed and return them to Operations when finished.



10.10 Ozone Depleting Chemicals (ODC) Contractors involved in servicing, maintaining, repairing or disposing of refrigerant containing equipment must follow site Refrigerant Management, Recovery, Disposal and Reporting procedure and Title 40 of the Code of Federal Regulations, Part 82, Protection of Stratospheric Ozone. Copies of all refrigerant service/use/release forms must be provided to EHS.

Applicability – • Applies to all contractors.


References – • 25254 Refrigerant and Ozone Depleting Compound Management • 25225 Management of Demolition Materials, Excavation and Debris • 25226 Waste: Kalamazoo Waste Handling & Disposal

10.11 Bloodborne Pathogens Bloodborne pathogens can be found at Pfizer in research and development, in the animal health buildings and may be used in various testing throughout laboratories on the Kalamazoo Site. Contractors who are required to come in contact with BBP’s should be adequately trained in handling, clean-up and emergency procedures. Waste created from the use of BBP’s should be considered hazardous and will be identified with the following symbol:

Contractors coming in contact with potentially contaminated fluids should be knowledgeable in the subject and use of “universal precautions” as they are expected to comply with this system of personal protection. “Universal Precautions” as defined by OSHA Standard 1910.1030 subpart b are “ an approach to infection control where all human blood and certain human body fluids are treated as if known to be infectious for HIV, HBV, and other bloodborne pathogens.”



10.12 Radiation

Pfizer is proud to be one of the largest pharmaceutical, fine chemical manufacturing, and medical related research institutions in the world. In our research, we use radioactive material (RAM) and radiation-producing devices. We operate under licenses issued by the U.S. Nuclear Regulatory Commission (NRC) and registrations issued by the Michigan Department of Community Health (MDCH). Pfizer must comply with all applicable rules and regulations. Violation(s) of these requirements could result in civil penalties (fines) or modification, suspension or revocation of the licenses or registrations. We are required to tell you what NRC and State of Michigan requirements apply to your work and to post Notices of Violation involving radiological working conditions. We do this to assure a safe working environment and to comply with the governmental requirements.

The Radiation Safety Officer (RSO), a trained health physicist, is responsible for the administration of the Radiation Safety Program. Other health physicists at Pfizer are trained in dealing with radioactive materials and the effects of radiation. The Radiation Safety Committee has the responsibility to oversee the use of licensed material and to review the Radiation Safety Program.

Radiation Safety (RS) provides safety instructions that protect the worker, the public, and the environment. We are committed to provide our customers with services and support in the use of ionizing radiation that meet or exceed all regulatory requirements. Access to Radiation Sources Our license and state registration covers RAM and radiation-producing devices stored or used at:

Farms Research Complex

Laboratories/Downtown Complex

Portage Road Manufacturing and Research Complex (including B248 Kilgore Rd.)

RAM and equipment containing RAM are labeled with the international symbol for radiation (purple or black tri-foil on a yellow background) shown below. In addition approved laboratory areas where radiation sources are stored or used are posted with the symbol to acknowledge their possible presence.

CAUTION

RADIOACTIVE MATERIALS In order to clean, maintain or modify these areas individuals may be required to attend Ancillary Radiation Worker Training or Laboratory Radiation Worker Training. A Radiation Work Permit may be required.



All material and equipment containing radioactive sources are handled or operated only by personnel trained in the safe use of RAM.

Your Rights and Responsibilities

Specific rights and responsibilities are detailed in State and Federal rules and regulations, and include: • Your right to receive information on radiation, its possible risks or effects, and precautions and instructions to minimize your exposures. • Your right to request reports of your radiation exposures (monitored personnel). Most nonusers and visitors are not required to wear dosimetry. • Your right to choose to decline to enter radiation use areas. • Your responsibility to observe the provisions for the protection of personnel from radiation and RAM. • Your responsibility to report to RS any condition which may lead to or cause a violation of applicable licenses and registrations or which may lead to unnecessary exposure to radiation or RAM. • Your responsibility to maintain your exposures to radiation “As Low As Is Reasonably Achievable” (ALARA). Your supervisor and RS will provide guidance and assistance.

Applicable Rules, Regulations, and Licenses Conditions State and Federal regulations require that current copies of the following documents be made available to employees for review. These documents are located in the RS office. FEDERAL • NRC regulations contained in Title 10, ENERGY, Code of Federal Regulations (CFR), Parts 19 & 20. • The NRC Type A Broad Scope license, license conditions, all documents incorporated into the license by reference, and all license amendments. • Operating procedures applicable to NRC licensed activities. • Any notice of violation involving radiological working conditions, proposed imposition of civil penalty, or order issued by the NRC.

STATE • The acknowledgment of State registration. • Operating procedures applicable to work under the registration.

If you have any questions, contact the Radiation Safety Officer @ 269-833-9364

10.13 Portable Ionizing Radiation Purpose – Provide protection for personnel and control over operations that involve the use of portable sources of ionizing radiation (such as the use of X-rays to inspect piping and welds).



Requirements – • Contractors must obtain a Safe Work Permit from Operations or the Mechanical Integrity

group where sources may exceed 2mR/hour. • Contractors must fill out a Safe Work Permit to identify the scope of work and the mechanisms

to minimize personnel exposure to ionizing radiation. • X-ray work cannot proceed without approval from operating unit.

Applicability – • Applies to contractors who will bring portable ionizing radiation sources on site. Site-Specific Training requirements • Site Mechanical Integrity provides as needed. References – • 25923 Portable Ionizing Radiation Source Permitting • 25922 Safe Work Permit • MIOSHA Construction Part 681

10.14 Asbestos Awareness

Purpose– To inform all contractors working on site that Pfizer facilities may have asbestos containing materials in areas such as, but not limited to: insulating materials, transite wall boards, vermiculite, cement, lab working surfaces. In addition, the purpose is to inform contractors who might be working in those areas, what steps to take if asbestos containing materials are disturbed. Requirements – • Building and construction contractors are expected to comply with all MIOSHA provisions,

including the annual 2-hour asbestos awareness training. • If asbestos containing materials are discovered or disturbed, contractors must notify Pfizer

project representative or KCA immediately and barricade the area to prevent further contamination.

• Any suspected asbestos containing materials must be treated as asbestos-containing until tested to show otherwise.

• Assure contractor employees are aware of Pfizer asbestos labeling systems: • A yellow sign located on building entrances where asbestos is known to exist. • Asbestos containing materials are marked with red letters, “ACM” • Non-Asbestos containing materials are marked with black letters, “NON-ACM”. • All building trades, custodial contractors, and all others who may be potentially exposed to

asbestos-containing materials must have completed an annual 2-hour Asbestos Awareness training at a minimum. Abatement contractors must be certified by the state of Michigan, and have their employee training records available for auditing purposes.

• Contractors must assure care when dealing with traced lines. • Contractors must be cautious of lines that may contain double layers of insulation concealing

asbestos containing materials. For example steam headers on trestle systems are likely to contain ACM on an inner layer of insulation.



Applicability – • Applies to all building and construction contractors. Site-Specific Training requirements – • Orientation covers asbestos labeling systems. • No additional site specific training required. References – • SITE-EHS-28292: Asbestos Management • MIOSHA Construction Part 602

10.15 Asbestos-Containing Material

Pfizer Kalamazoo sites house many miles of process piping. Asbestos-containing material (ACM) has been identified in portions of the thermal system insulation of the piping. These portions will be identified as follows:

Likewise insulation that does not contain asbestos with identified – NON-ACM (NON Asbestos Containing Material) Non-thermal system insulation ACM (i.e. ceiling and floor tile, laboratory bench tops, etc) has also been identified and will be marked with labels or stickers. Contractors who come in contact with ACM must follow all state and federal regulations pertaining to asbestos. Only properly licensed, trained, qualified individuals will be allowed to disturb any material containing asbestos. Contractors working with asbestos containing material (ACM) must notify their Pfizer Contact prior to beginning work.



11.0 Site Permitting

11.1 Safe Work Permit

Purpose – Outline requirements for using the safe work permit system. The Safe Work Permit at Pfizer is a form that has a step by step checklist that ensures applicable jobs are performed safely. All contractors performing procedures using permits are required to take site-specific permit training annually. The purpose of this procedure is to describe the process by which personnel review and document safety information prior to completing work. The Safe Work Permit is designed to incorporate the permitting requirements for Hot Work, Confined Space Entry, Energy Isolation, Heights, Trestle and Roof access, Portable Ionizing radiation Sources (X-ray), Line Entry/Line Break, and working with exhaust ducts. The Permit is applicable for all Pfizer colleagues and contractors who work at the Kalamazoo Site. These permits are required for certain job activities, are job specific, must be posted at the job site and cannot be shared with other projects. All information regarding the Safe Work Permit program may be found in SOP 25922, on the Environmental Health and Safety webpage. Contractors are to contact their supervisor to schedule this course. Pfizer’s Safe Work Permit covers the following types of work: Lockout/Tagout This program is used to control hazardous energy sources when equipment or machines are being serviced, or maintenance is being performed. Document of employer provided training is required prior to performing work on site. Confined Space Entry: Tanks, vessels, pits, and dikes may all be considered confined spaces. The Confined Space Entry Permit identifies and controls the hazards associated with entering a confined space. A sign posted near the entrance identifies permit Required Confined Spaces. At least 2 people must verify the atmosphere prior to entering any confined space. One of those individuals verifying the atmosphere must be a Pfizer employee. Hot Work: All welding, cutting, grinding, using electric tools, and other work that has the potential for starting a fire or causing an explosion must have a SWP before work commences.

Type I – Welding, cutting, spark producing tools. • Hands on Fire Extinguisher training is required for all participants. Type II – Electrical tools used in an electrical classified area.

Line Entry An opening in process piping at Pfizer is considered line entry. This will identify any hazards and assure that all measures have been taken to guard against accidental exposure to personnel working on the system. Radiation Work A Radiation Work Permit must be obtained before beginning work on any system containing radioactive material.



Rules to be followed for the SWP: • The permit checklist must be filled out completely. Skipping a step defeats the purpose of the

permit and could lead to an accident.

• All authorized signatures must be obtained. This ensures that those signing the permit agree about the type of work to be done and are satisfied that the area is safe.

• The permit must be posted at the job site so that it can be easily seen.

• Each safety permit applies to one job being performed at a specific location at a defined time

by certain workers. This means that permits CANNOT be shared by Contracting Firms and moved from job to job. If work needs to be done on another system, or on a different day, another permit needs to be obtained.

• The permit must be returned to the office where it was issued upon completion of the job.

• Permit is required to be completed at the end of the shift.

• It is very important that all people involved in the permit process know when the job is

finished.

Requirements – Contractors must conform with Safe Work Permit Requirements • Submit prior to starting work for hot work, confined space (including duct work), portable

ionizing radiation source work, line entry/line break, lockout/tagout, working at heights, roof access, and Portage Site trestle work outside of the guarded catwalk.

• Prior to starting work, all workers must check in with the Operating Unit Representative to determine the requirements for the specified job.

• The Safe Work permit requires all green sections be filled out, along with any additional selected topics in Section 5 of the permit.

• Sections 1through 5 are to be completed by the worker(s) requesting the permit.

Applicability – • Applies to all contractors working in Pfizer Kalamazoo locations. • Applies for all work conducted in API and Utilities. • Applies in Building 41, Downtown, and Richland Farm areas for permitted activities.

Site-Specific Training requirements • Safe Work Permit Training given by KCA. Required annually. • Annual refresher training.

References – • 25922 Safe Work Permit



11.2 Excavation Permit

Purpose– To inform all contractors working on site that Pfizer has an excavation permit. The purpose of the program is to protect personnel working in and around excavations and trenches. An excavation permit is required for any excavation on site. Requirements – • Pfizer has an excavation permit process • Safe Work Permit training is required. • Contractors must review work with a KCA representative to address items in the Job Safety

Analysis (JSA). • Contractors must have competent person on site during exaction. • Contractors must comply with MIOSHA requirements, including training and equipment

requirements. • KCA will review all excavation permits prior to digging. • Contractors must ensure that qualifications for “competent” and “qualified” persons meet

minimum MIOSHA requirements. − A “competent person” is defined as “one who is capable of identifying existing and

predictable hazards in the surroundings or working conditions which are unsanitary, hazardous, or dangerous to employees, and who has the authorization to take prompt corrective measures to eliminate them”

− A “qualified person” is defined as one who, by possession of a recognized degree, certificate or professional standing, or who by extensive knowledge, training, and experience, has successfully demonstrated his ability to solve or resolve problems relating to the subject matter, the work or the project

• Before entering an excavation greater than four feet, entrants must have authorization by their competent or qualified person.

• All involved with an excavation must understand the hazards of excavations, by completing MIOSHA required training.

• When there is work taking place in the excavation, there must be a minimum of one additional person in the immediate area outside the excavation to maintain communication with the entrant. In addition, atmospheric testing will be required.

• Contractors must investigate underground utilities prior to any excavation. • Contractors must follow Pfizer Environmental procedures for disposal of excavated materials,

such as concrete, asphalt and soil. • Contractors must not enter the excavation or trench until qualified person authorizes the entry

and the excavation permit is filled out completely by all parties. • If Lockout/Tagout or Line Entry jobs will take place inside an excavation, contractors must

ensure that site-specific training has been completed. • Must have their employee training records available prior to receiving Pfizer site-specific

training and also for auditing purposes. A “Qualified Person and Competent Person” in charge of this excavation must be identified before the exaction can occur. Excavation permits will be required to be “Posted” at the job site, along with contact names and phone numbers for the Project Manager, Construction Manager/EMA/CAC, and Qualified Person



Applicability – • Applies to all building and construction contractors. Site-Specific Training requirements • Safe Work Permit Training required annually. • Current Lockout/Tagout Training by employer as applicable. • Training records maintained by KCA. References – • 25845 Lockout/Tagout • MIOSHA Construction Standards Part 9 • 25922 Safe Work Permit

11.3 Crane / Critical Lift

Purpose – Outline requirements for using cranes and other heavy equipment. Requirements – • Crane use is regulated by the Kalamazoo/Battle Creek International Airport and the FAA

within a designated perimeter at the Pfizer Portage, MI sites. Contact Construction Management to assure crane boom height is compliant with current permit / regulations.

• All raised crane booms on the Pfizer site must fly an airfield safety flag meeting FAA requirements (High visibility international orange / white checkered pattern).

• A Pfizer Critical Lift Permit is required prior to any of the following types of lifts: − When two or more cranes are used to lift − Lifts equal or are greater than 24,000 lbs − Crane will lift Personnel − Crane will “Walk” with load − Load will be upended and weighs greater than 10,000 lbs − The loads equal or are greater than 75% of Rated Load Capacity.

• Contractor must assure that placement of crane is safe for area and all obstacles have been identified.

• Contractor must assure that crane is on stable ground. • Contractor must assure that crane is appropriate for the job and kept in good condition. • If crane/heavy equipment will block a roadway, contractors must contact the Fire Station

(3-5122) and Transportation (3-3767) to obtain approval. The crane/heavy equipment operator must meet MIOSHA qualification requirements in order to operate the equipment. Must be able to verify a “competent person” is to inspect the crane/heavy equipment prior to and during use. Operator must be trained in the capabilities of the crane/heavy equipment and its attachments, the purpose, use, and limitations of controls, and daily inspections. Contractor shall review height requirements with a Pfizer representative or construction manager prior to crane use.

Applicability – • Applies to all contractors.



Site-Specific Training requirements • None required. References – • Pfizer Critical Lift Program • MIOSHA Construction Part 10

11.4 Demolition Permit

Purpose– To inform all contractors working on site that Pfizer has a Demolition Permit requirement. The purpose of the permit is to ensure that all testing, identification, waste management and administrative systems have been addressed prior to demolition. Demolition is defined as removal of equipment and facilities that will not be replaced. Requirements – • Contractors must review demolition work with a Pfizer representative and KCA to determine

appropriate steps to take. • Refer to permit for color code requirements for identifying systems to remain and systems to be

removed prior to starting work. • Demolition work may also require the use of Lockout/Tagout, and Safe Work Permit as

identified in the Job Safety Analysis (JSA). • Contractors must identify a competent person for each demolition project and must ensure that

they are trained on the Pfizer processes. Applicability – • Applies to all building and construction contractors. Site-Specific Training requirements • Lockout/Tagout, , Hot Work and Confined Space Entry training, if applicable. Required

annually. • Safe Work Permit Training required annually. • Safe Work Permit Training records maintained by KCA. References – • KCA Demolition Permit • MIOSHA Construction Part 20

12.0 Basic Safety Requirements

12.1 Fall Protection

Purpose– Outline requirements for contractors working in elevated positions greater than four (4) feet above a lower level or work closer than six (6) feet from unprotected edges. It also includes work closer than six (6) feet from unprotected edges greater than four (4) feet above a lower level. Fall protection is classified into two separate categories depending on work classification.



Requirements – • Contractors must ensure that each worker who is at risk is provided with 100% fall protection

to provide protection from the fall hazards. Such protection includes approved guardrails, personal fall arrest systems, safety net systems, and hole covers

• Contractors must comply with MIOSHA requirements, including training and equipment requirements.

• Small diameter pipes, cable trays and electrical conduit are not to be used for anchor points. • Roof work -- If performing work within six feet of the edge, fall protection must be

implemented. Warning system is not an acceptable means of providing fall protection. Site-Specific Requirements for Construction Ladder use at heights greater than 6 (six) feet -

− Complete work whenever possible with the use of mechanical lifts or scaffolding. − If a ladder is required and there is an engineered tie point or structural steel (> 4 inches)

available directly overhead and within a reasonable vertical distance, personal fall protection shall be worn.

− Where a ladder is needed and the first two conditions cannot be met, a second person shall be available to hold the ladder and remind the person to stay within the confines (between the vertical rails) of the ladder.

− Step ladders must be used according to MIOSHA regulations and inspected and maintained in good condition.

− The step ladder must be used in the open and locked position and not be used leaning against walls and equipment.

− Wood ladders are not allowed on Pfizer site. Exceptions exist for certain production equipment. Contact your Pfizer Representative or KCA for approval.

Applicability – • Applies to all building and construction contractors. Site-Specific Training requirements • None required. References – • MIOSHA Construction Standards Part 45 (Fall Protection), Part 11 (Fixed and Portable

Ladders), Part 21 (Guarding of Walking and Working Areas) • MIOSHA General Industry

12.2 Hazard Communication Purpose– To inform all contractors working on site how to access Pfizer chemical information and to inform contractors of their site requirements that all contractors bring Material Safety Data Sheets (MSDS) for chemicals they bring on site. Pfizer abides by the Michigan “Right-to-Know” regulations and makes information pertaining to the chemical hazards found at their workplace available to all contractors. Specific questions regarding Hazard Communication should be directed your supervision or Pfizer Contact.



Requirements – • Contractors are expected to comply with all MIOSHA provisions. • Contractors must have in their possession, on site, MSDSs for any hazardous chemicals that

they bring on site. • Containers must be labeled according to regulations. • Contractors may request Pfizer MSDSs from their Pfizer representative or operating unit

personnel where work is taking place. • Contractors must be aware of Pfizer labeling system. NFPA and in-house precautionary

labeling systems are used. • Contractors must have their employee training records available for assessment purposes. • If work takes place in laboratories, ensure that the Chemical Hygiene plan has been reviewed

and proper precautions have been implemented. Applicability – • Applies to all contractors. Site-Specific Training requirements • New Contractor Orientation Test and Annual Refresher • No additional site specific training required. References – • 25789 Hazard Communication (HAZCOM) Program • MIOSHA General Industry Parts 92 and 430, Construction Part 42 and 430 (Right to

Know/Hazard Communication/Retention of DOT Markings, Placards and Labels), Part 431 (Hazardous Work in Laboratories)

12.3 Noise / Hearing Conservation

Purpose – To outline requirements for Hearing Conservation and use of Hearing Protective Devices Requirements – • Contractors must have their own established Hearing Conservation Program, meeting

MIOSHA requirements, if applicable to their work. • Pfizer requires hearing protection to be worn in areas where noise levels are 85 decibels or

above. Signs are posted at entrances to buildings/areas where hearing protection is required. • Contractors must provide their employees with hearing protection that reduces noise levels to

below 85 decibels. • Contractors must provide signs or other means to alert personnel in the area if their work is

creating noise levels above 85 decibels. Applicability – • Applies to all contractors who will be exposed to noise above 85 decibels either by their work

or by proximity to loud equipment. Site-Specific Training requirements



• None required. References – • 26887 Hearing Conservation Program • MIOSHA Construction Part 680

12.4 Hot Work Purpose– To inform all contractors working on site that Pfizer has a Hot Work permit system.

Type I – Welding, cutting, spark producing tools. Type II – Electrical tools used in an electrical classified area.

Requirements – • Contractors must review work to be done to determine if hot work program applies. • If scope of work includes activities described above, all contractors involved in this activity

must complete Pfizer Safe Work training program. • Contractors must ensure that persons serving as fire watch must have annual hands-on fire

extinguisher training every three years as well as complete the Pfizer Safe Work training program.

• Contractors must provide at least a 10 # ABC fire extinguisher for fire watch duties. • Contractors must not start hot work activities until the hot work permit is filled out completely

by all parties. • The Fire Watch must wear a red safety vest to be easily identifiable. • The Fire Watch must stay on the hot work site for a minimum of 30 minutes after the hot work

is complete and up to four hours in the truss area of B41. • Contractors may need to provide more than one fire watch if they cannot maintain a line of

sight with the hot work activities. • Contractors with cell phones, PDAs, laptop computers and other electronic devices must ensure

that they do not take these devices into facility areas that are electrically classified. • Contractors that use non-Pfizer vapor testers for additional monitoring must assure that

employees have been adequately trained and that the instruments are in good working condition and calibrated.

Applicability – • Applies to all building and construction contractors. Site-Specific Training requirements • Safe Work Permit Training • Vapor Tester Train the Trainer • Training records maintained by KCA. References – • 25920 Hot Work Program • 25922 Safe Work Permit • MIOSHA Construction Part 7



12.5 Housekeeping Purpose – Outline expectations for conditions or work areas under the control of contractors. Requirements – • Do not block work areas, aisles, fire exits, stairs and other emergency equipment. • Store materials, equipment and tools in an orderly manner. • Ensure work areas are kept clean and organized during the day and especially at the end of the

work day. • Electrical cords to be maintained bin an orderly fashion, elevated when possible to prevent trip

hazards. Applicability – • Applies to all contractors. Site-Specific Training requirements • None required.

12.6 Incident Reporting

Purpose – Outline requirements for reporting incidents Requirements – • Contractors must report all incidents including injuries, near misses, spills, and property

damage. − All incidents must be reported to a Pfizer representative and KCA as soon as possible. − Reports must be received by KCA within 48 hours of the incident. Initial reports are

required within this time frame. If additional time may be required to complete the investigation, a supplemental report can be filed. Keep KCA informed of the progress of any injuries, damages, repairs or corrective action.

Applicability – • Applies to all contractors. Site-Specific Training requirements • None required. References – • Contractor Incident Workflow sheet • Contractor Incident Investigation Report

12.7 Job Safety Analysis (JSA)

Purpose – Outline requirements for identifying hazards associated with all types of work.



Requirements – • A Job Safety Analysis (JSA) is a written plan prepared by the contractor that highlights safety-

related concerns related to the contracted scope of work and how they are to be addressed. • Contractors must submit a written JSA to Construction Management for approval and for KCA

approval for capital projects and other complex maintenance or construction activities. • For jobs with limited scope, a written JSA may not be required. A verbal review with KCA on

the jobsite may be sufficient. Applicability – • Applies to all contractors. Site-Specific Training requirements • None required. References – • Job Safety Analysis (JSA) Form

12.8 Lead Awareness

Purpose– To inform all contractors working on site that Pfizer facilities are likely to contain lead on any painted surface. Requirements – • Building and construction contractors are expected to comply with all MIOSHA provisions of

the Lead standard. • If performing sanding, grinding, other abrasive work or any hot work activities on painted

surfaces, contractors must follow their company lead program, including medical surveillance, air monitoring and PPE.

• Must have their employee training records available for assessments. • Contact Pfizer representative and/or Pfizer Environmental Representative to ensure disposal

requirements are met. Applicability – • Applies to all building and construction contractors. Site-Specific Training requirements • No additional site specific training required. References – • 25694 Lead Management • MIOSHA Construction Part 603



12.9 Line Entry

Purpose– To inform all contractors working on site that Pfizer has a line entry program. The purpose of the program is to protect personnel and control operations which involve the physical opening of a process or service piping line. Requirements – • Contractors must review work to be completed with a Pfizer representative to determine if a

line entry permit will be required. • Contractors may request Pfizer MSDSs from their Pfizer representative or operating unit

personnel where work is taking place. • If scope of work includes Line Entry, all contractors involved in this activity must complete the

Safe Work Permit. • Contractor’s employer must provide proper training, if applicable, in Lockout/Tagout and

Confined Space Entry. • Minimum PPE requirements include a face shield and chemical-resistant goggles along with a

face shield. Pfizer operations will indicate additional PPE requirements on the Safe Work Permit.

• Contractors must work with Pfizer operations to ensure that PPE is adequate for potential chemical exposure.

• Contractors must not break into the line until the Safe Work Permit has been approved. Applicability – • Applies to all building and construction contractors. Site-Specific Training requirements • Safe Work Permit Training. Required annually. References – • 25922 Safe Work Permit

12.10 Lockout/Tagout

Lockout/Tagout (LOTO) procedures are used to control hazardous energy sources during service or maintenance where the unexpected release of energy could cause bodily harm. All contractors performing procedures using LOTO are required to take site-specific Safe Work Permit annual training. Suppliers are required to train their employees on the general principles as required under MIOSHA’s Control of Hazardous Energy Sources standard documentation must be provided to KCA prior to SWP training. Contractors are to contact their supervisor to schedule this course. Prior to LOTO of any Pfizer equipment procedures must be reviewed with operations for proper LOTO and verification that the system is de-energized. Hazardous energy sources come in many forms including: • Electrical



• Mechanical • Thermal • Potential • Pressure • Chemical Key elements on Lockout/Tagout at Pfizer sites: • Red locks used only for LOTO. • Any control lock must be blue or any other color then red. • Every person must have personal control of all energy sources • Lock box must be used for Confined Space and Line Entry permits. • Tag in field should indicate only the lock box number • Tag on lock box contains persons name, date, and unit (or company) • Procedure must be complete before beginning LOTO • Control lock must be used with Line Entry and Confined Space Entry permits. • Tags must be secured with the shank of the lock or a plastic cable tie (no string, twist ties, etc.) • Always test on/off switches to be sure system is de-energized

− All individuals having work duties on that piece of equipment must physical lock-out the equipment

12.11 Personal Protective Equipment (PPE)

Purpose– Outline minimum requirements for personal protective equipment use on Pfizer sites. Requirements – • Contractors must train and provide their employees with PPE applicable for hazards present. • Safety glasses that meet ANSI Z87.1 must be worn while performing maintenance and

construction work and when entering any area posted as requiring safety glasses. • Hard hats that meet ANSI Z89.1 must be worn with bill forward. Metal hard hats are not

allowed on site. • Gloves must be selected and worn. • Chemical protective clothing shall be provided by contractor where the possibility of chemical

exposure. Contractors must ensure that PPE materials are adequate for the chemicals. A Pfizer Representative or KCA can assist to determine appropriate materials.

• Clothing contaminated with chemicals/products, must be disposed of onsite. Follow waste handling procedures for proper disposal of contaminated clothing.

• Contractors must dress appropriately for work being performed. • Foot protection must be provided according to MIOSHA regulations that meet ASTM F2413 • Contractors working in GMP areas must be sure that additional dress/gowning requirements

and training have been met. Note that Building 41 requires long sleeves in all GMP areas.



Applicability – • Applies to all building and construction contractors. Site-Specific Training requirements • Gowning training where applicable. References – • 25196 Personal Protective Equipment (PPE) • MIOSHA Construction Part 6

12.12 Powered Industrial Trucks (PIT), including Aerial Lifts Purpose – To inform contractors of Pfizer requirements. Requirements • Contractors must ensure that all aerial lift and powered industrial truck operators have been

trained, according to MIOSHA regulations. Proof of training must be readily available upon request.

• Contractors must ensure that aerial lifts and PITs are inspected before each use and maintained in good condition.

• Aerial lifts should be used primarily for lifting personnel. If lifting equipment, it can only be done according to manufacturer’s requirements.

• Scissor lifts do not require additional fall protection other than the guardrail system, unless you will be exiting to an elevated work surface. Contractors must be tied off before exiting the scissor lift.

• JLGs require a full body harness and lanyard when in the basket. Additionally, if exiting to an elevated work surface, double lanyards are required to ensure 100% fall protection.

Applicability – • Applies to all contractors who will use powered industrial trucks and aerial lifts. Site-Specific Training requirements • No additional site specific training required. References – • 26900 Powered Industrial Trucks & Aerial Lifts • MIOSHA Construction Part 32 (Aerial Lifts), General Industry Part 21 (Powered Industrial

Trucks)

12.13 Respiratory Protection Purpose – Outline requirements for Respiratory Protection Respiratory hazards may be associated with the work areas you will need to access. If you need to use respiratory protection to do your job you must have medical clearance to use respiratory protection and training on its use. In addition, certain forms of respiratory protection will require fit testing. In most cases, your employer will be required to provide the respirator, medical clearance,



training and fit testing. If you need to use the Pfizer breathing air system, your Pfizer Contact may provide a compatible respirator and will arrange for training specific to its use. You must inform your Pfizer Contact if the work or equipment you will bring on site will generate a respiratory hazard. If the work you are doing will introduce a respiratory hazard you must protect yourself and alert any one else in the area to do the same. Requirements – • Contractors must have their own established written Respiratory Protection Program, meeting

MIOSHA requirements, if applicable to their work. • Contractors should work with Pfizer Representative, KCA and/or Operations to ensure proper

respirator selection for each job when the hazard presented is due to a Pfizer material. • If contractors will use Pfizer breathing air system, they must show proof of “ability to wear” a

respirator before being allowed to use the breathing air system. • Contractors must be aware that hoods used to supply breathing air have Snap-Tite® fittings for

Pfizer’s breathing air header fittings. Contact KCA to obtain equipment. • The breathing air system is continually monitored. If a hazard is detected, a warning system of

seven (7) bells will sound to alert users to discontinue use of the breathing air.

Applicability – • Applies to all contractors who will use respiratory protection.

Site-Specific Training requirements • Must be familiar with site breathing air system header connections.

References – • 26951 Respiratory Protection Program • MIOSHA Construction Part 451

12.14 Scaffolds

Purpose – Outline requirements for using scaffolds on Kalamazoo Pfizer site.

Requirements – • Scaffolds must be designed, erected, inspected and tagged by trained, competent

persons/qualified persons in accordance with MIOSHA requirements. Scaffolds that do not meet MIOSHA requirements are not allowed on site.

o Red – DO NOT USE o Yellow – No hand rail fall protection required. o Green – General access upon completion of daily inspection.

• Prior to work, designated persons must be able to verify he/she has had proper training. • The scaffold must be inspected by the designated competent person prior to allowing work to

proceed from the scaffold. • The scaffold shall be equipped with an inspection tag with daily notations by the competent

person that the scaffold has been inspected and approved for use. • Do not allow tools, materials, or debris to accumulate on scaffolds. • Fall protection is not required when working from the platform area if the guardrails meet

MIOSHA regulations.



• Identification of controlled access zones (CAZ).

Applicability – • Applies to all construction and trades contractors.


References – • 25821 Scaffolding • MIOSHA Construction Part 12, General Industry Part 5

12.15 Vapor Test Use Purpose – Inform contractors of Pfizer requirements for using instruments to test atmospheres for Hot Work, Confined Space Entry Permits.

Requirements – • Contractors must use Pfizer vapor testers to document atmospheric tests for Hot Work,

Confined Space Entry and Duct Entry permits. • Contractors must be knowledgeable in the use and span calibration of Pfizer vapor test

equipment before documenting atmospheric tests on Pfizer permits and are required to attend Safe Work Permit training annually.

• Contractors may use their own vapor testers as additional verification of a safe atmosphere. • Contractors that use non-Pfizer vapor testers for additional monitoring must assure that

employees have been adequately trained and that the instruments are in good working condition and calibrated.

Applicability – • Applies to all contractors. • Site-Specific Training requirements • Safe Work Permit Training

References – • 25856 Before Use Meter Performance (BUMP) Testing for Portable Gas Monitors • 25856-S02 PhD Ultra Operator's Guide • 25856-S03 GasAlertMax Operator's Guide • 25856-S04 PhD Lite Operator's Guide • 25856-S05 RKI Eagle Operator's Guide

12.16 Special Site Specific Considerations

If your work requires you to enter research areas either at the downtown campus or the veterinary research complex in Richland, Michigan there are unusual circumstances you may encounter. You may see animals in cages, laboratory, viral and bacteriological studies that use growth media, and studies that use syringes and other equipment that you may not be familiar with. Special permission must be obtained before you enter any area that is designated as RESTRICTED. You must check



with your Pfizer contact, or Pfizer Facility Management about special gowning, shower in and shower out procedures, and follow all Personal Protective Equipment (PPE) Requirements before you may enter these areas.

VMRD – Richland VMRD – Downtown Kalamazoo PGM – Portage PGM – Kilgore Road – B248 ______ - Milham Road – B212

Documents

Pfizer Kalamazoo Contractor Manual – Version 2.0 – Last ...kalamazoocontractoradministration.pfizer.com/Files/Contractor... · Pfizer Kalamazoo Contractor Manual ... **In Case