Quality Systems Compliance 1 FDA Medical Device Quality Systems Compliance

Quality Systems Compliance 1

FDA Medical Device Quality Systems Compliance


Agenda• Introductions, Attendance Sign in • Domestic and International Quality Systems • Food and Drug Law • Organization of the FDABreak ( 15 min)• Procedures• FDA Quality Systems Regulations ( 21 CFR 820)Lunch• Labeling• Complaint Handling• Record KeepingBreak (15 Min)• FDA Quality Systems Audits• Exam• Course Evaluations


US and European Regulatory Systems

Congress Passes Laws

US

FDA Writes Regulations

Companies Develop Quality Systems Procedures

FDA Audits for Compliance to Regulations

European System

European Commission Issues Directives

Member Countries identify independent Notified Bodies

Harmonized Standards adopted by the Member Countries

Notified Bodies Audit for Compliance to the Directive and Harmonized Standards


US vs European Laws

US• Food, Drug and

Cosmetics Act• Medical Device

Amendments (1976)• Safe Medical Devices

Amendments (1990)• FDAMA (1997)

Europe• Medical Device

Directive (MDD) 1993• Active Implantable

Medical Device Directive (AIMD) 1990


US vs. European Quality System Requirements

US• 21 CFR 820

(Also known as the QSR)

• Guidance Documents

Europe• Essential Requirements• Harmonized Standards• ISO 13485


Background of the FDA

• Biologics Control Act. 1902

• The Pure Food and Drug Act-1906

• Food Drugs and Cosmetics Act -1938– Medical Device Amendments to the FDCA –

1976– Safe Medical Devices Act- 1990– FDAMA- 1997


CBERCenter for Biologics

Evaluation and Research

CDRHCenter for Devices and

Radiological Health

CDERCenter for Drug

Evaluation and Research

Offices of Medical Product Regulation within theOffices of Medical Product Regulation within theU.S. Food and Drug Administration (FDA)U.S. Food and Drug Administration (FDA)


Drugs “[an article] intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease . . . [or] . . . intended to affect the structure or any function of the body” FD&C Act, §201(g)(1)

Devices

“. . . An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar related article . . . intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease . . . or intended to affect the structure or any function of the body . . . and which does not achieve any of its primary intended purposes through chemical action within or on the body . . . and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes” FD&C Act, §201(h) (emphasis added)

Biologics “ . . .any virus, therapeutic serum, toxin, anti-toxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product applicable to the prevention, treatment or cure of diseases or injuries” PHS Act, §351(a)

DefinitionsDefinitions


FDA Center Responsibilities

Blood Products

Vaccines

Gene/Cell Therapy

Stem Cell Research

Stethoscopes

MRI Scanners

Hemodialysis Machines

Surgical Instruments

Microwave ovens

Zocor

Viagra

Tylenol

Celebrex

Penicillin

CBER CDRH CDER


RegulationsCBER CDRH CDER

Biologics

•21 CFR 600/601/610

Blood

•21CFR 606

CLIA

21CFR 1270, 1271 (tissue)

21 CFR 58 (GLP)

21CFR 11 (electronic records)

Devices

•21 CFR 21 CFR 820 QSR (GMP)•21 CFR 56 (IRB’s)

•21 CFR 58 (GLP)

•21CFR 11 (Electronic records)

•21 CFRR 800-1050 (devices)

•21 CFR 807 (510(k))

•21 CFR 812 (IDE)

Drugs

• 21 CFR 56 (IRB’s)

• 21 CFR 58 (GLP)

• 21CFR 11 (Electronic records)

•21 CFR 210, 211 (Drug GMP’s)

• 21 CFR 312 (IND)

• 21 CFR 314 (NDA)


Class Exercise - FDA Organization

Which division of the FDA has authority over the following products?

• Blood banks• Bandages• Computer terminals• Bone graft material• Pre-filled antibiotic syringes• Lasers for eye surgery• Artificial skin graft materials• Contact Lenses• Dog and Cat Food


Quality System

A Medical Device Quality System is designed to assure that products are Safe and Effective for their Intended Use

and

Consistently meet the specifications as defined by results of clinical and/or detailed technical design and validation


Quality Control



Quality System Basics (ctd)

• Quality is everyone’s responsibility

• Quality has measurable attributes

• Specifications are the of a Quality System

• Documented policy and procedures contribute to consistency

• Quality planning is essential


Quality Systems Basics (ctd)

• Clinical evaluation is the basis for safety and effectiveness

• Design Controls and validation assure that designs meet clinical expectations and specifications

• Process validation assures consistency• Identification, segregation and control of

materials and products prevents mix-ups• Documentation control is essential


Quality System Basics (ctd)

• Corrective and preventative action systems foster continual improvement

• Labeling is important

• Internal and external (FDA) auditing keeps quality systems up to date


The Documentation Pyramid

Quality Manual

Procedures

Work Instructions

Records (forms, notebooks, travelers)


Important Terms

• Device Master Record (DMR)-

• Device History Record (DHR)

• Design History File (DHF)• Technical File• Complaint• Corrective Action• Controlled Document• Engineering Change Order

(ECO)

• Labeling• Verification • Validation• Traceability• Medical Device Directive

(MDD)• Essential Requirements• Notified Body


Procedures

FDA 21 CFR 820 requires following written procedures


Group Exercise: Draw a House


Draw A House1. Read all instructions before beginning to draw the house2. Draw your house in the lower ½ of the page3. Begin by drawing a rectangle approximately 4 inches wide by 3 inches tall,

with the long side parallel to the bottom edge of the paper. The bottom of the rectangle should be 1 inch from the bottom of the paper.

4. Locate the center of the top edge of the rectangle. Put a small dot at that point.5. Put a small dot 1 ½ inches above the dot you just made. This dot will be

above the rectangle.6. Draw a line from the new dot to each edge of the top of the rectangle.7. Draw a door in the center of the rectangle. The door should be 3/4 inch wide

by 2 inches tall. The bottom of the door should touch the bottom of the rectangle.

8. Draw a window, approximately 1 inch square on each side of the door, 1 inch from the bottom of the rectangle. Hint: A average thumb is about 1 inch wide at the knuckle. The edge of each window should be ¼ inch from the nearest edge of the door.

9. Draw 4 panes of glass in each window by making a cross in each window. Each pane should be the same size.

10. Draw a chimney on the left side of the roof of the house. The chimney should be parallel to the left wall of the rectangle, touching the roof. The chimney should be ½ inch wide by 1 inch tall and go straight up.

11. Draw some smoke coming from the chimney. A squiggly line will represent smoke.

12. Put your pencil down when you are finished.


Quality System Processes• Management Controls• Design Controls• Materials Controls• Document Controls• Purchasing Controls• Production and Process Controls• Facilities and Equipment Controls• Document, Record and Change Controls• Corrective and Preventative Action• Labeling Controls• Handling, Storage, and Distribution controls• Servicing Controls• Statistical Techniques


Management Controls

• Possible careers – Internal Auditor– External Auditor– Quality Specialist– Quality Systems

Trainer


Who is an Auditor?

An AuditorAuditor is someone who comes in after the war is lost to bayonet the wounded…

Anon.


Management Controls21CFR 820 Subpart B

• Quality Policy Defined

• Management Representative

• Management Review

• Quality Systems Procedures

• Quality Systems Audits

• Trained Personnel


Design Controls

• Possible Careers– Design Engineer or

Technicians– Quality Test

Technicians– Clinical Specialists– Documentation

Specialists


Design Controls

A Medical Device Quality System is designed to assure that products are Safe and Effective for their Intended Use

and

Consistently meet the specifications as defined by results of clinical and/or detailed technical design and validation


Design Controls

• A Design Control System is intended to design products which

• provide safe and effective medical devices,• meet the clinical needs of the intended patient population, • provide outstanding value to the user, • satisfy the needs and expectations of our customers.

• Phased approach to product development• Each phase has deliverables• Design reviews are the checkpoints


Design Control Elements

• Design Planning• Design Input (Requirements)• Design Output (Specifications)• Design Reviews (Technical)• Design Verification (Meets Specifications• Design Validation (Meets clinical needs) • Design Transfer- (Moves from Design to

Manufacturing)• Design Changes (Formal Process)• Design History File (DHF)


Design Planning

• Feasibility Studies

• Risk Assessments

• Project Plan Defines Interfaces with Others

• Stage-Gate Methodology

• Constantly Changing


Design Input• Where

– Customers– Technical Papers– Medical experts– Service people

• What– Intended Use– Technical Requirements– Safety Issues

• How– Documented– Approved– Filed– Formal Change Control System


Design Output

• Final Design Specifications– Quantitative – Documented– Approved

• Final Risk Assessments

• Clinical Testing May Be Needed


Design Reviews

• Planned Formal Technical Reviews

• Independent Member of Review Team

• Documented


Design Verification And Validation

• Verification - Meets Specification

• Validations - Meets Intended Clinical Use

• Written Procedure Required

• Testing Must be Documented, Reviewed and Approved

• Software Must be Validated

• Manufacturing Processes Must be Validated


Design Transfer

• Design moves from R&D to Manufacturing• Manufacturing and Production

Specifications are Documented • Manufacturing IQ, OQ, PQ

– IQ - Installation Qualification (Equipment)– OQ - Operational Qualification( 1st ones meet

specs)– PQ - Performance Qualification (Consistently

repeatable)


Design Changes

• All changes to the design after release must be controlled (Engineering Change Control)– Re-validation may be needed

• Continues for the Life of Product


Design History File

• Record of the Development Process– Plans– Specifications– V&V Test Results– Design Reviews– Changes to the Design


Class Exercise-Design ControlsDr. Bright and Dr. Idea have found a novel way to produce a machine to determine if a heart attack patient has additional blockage in the coronary arteries that may be caused by the surgical bypass procedure (CABG). The machine non-invasively measures arterial flow by using Doppler sonar to determine if the arteries are blocked. It can be used in a patient’s home, by itself, on post heart attack patients who may be at risk for additional heart attacks. It transfers the data to a monitoring station at a EMS facility for 24/7 monitoring.

They have formed a company (The Bright-Idea Company), built a prototype and tested it in the lab on sheep and pigs. It worked great. Now they want to begin marketing it for use on humans.

1. Is the machine a medical device?2. What steps should Dr. Bright and Dr. Idea take before they can begin

marketing the machine? 3. What documents do they need to have on file?


Manufacturing and

Servicing the Product


Manufacturing and Service

A Medical Device Quality System is designed to assure that products are Safe

and Effective for their Intended Use

and

Consistently meet the specifications as defined by results of clinical and/or

detailed technical design and validation


Documents Controls

• Career Opportunities– Documentation Control

Specialist– Change Order

Coordinator– Drafter


Documents Controls

• Controlled System

• Review and Approval Required– Signature, Date – Authorized Personnel Listed in a Procedure

• Engineering Change Order Process (ECO)

• Electronic Records Require Special Security


Purchasing Controls

• Career Opportunities– Purchasing Agent– Buyer– Supplier Auditor


Purchasing Controls

• Written Procedures Required

• Supplier Selection Process– Approved Supplier List

• Purchase Orders – Detailed Specifications Needed – Supplier is Required to Have Current

Specifications

• Supplier Auditing


Identification and Traceability

• Career Opportunities– Receiving and

Inspection Coordinators

– Shipping Coordinators– Quality Technicians


Identification and Traceability

• Unique Identification of Product Through All stages of Receiving, Production, Installation, and Service

• Separate Accepted (Good) from Non- Conforming (Bad)

• Implants or Life Sustaining Product Requires Traceability to the User


Production and Process Controls

• Career Opportunities– Calibration Technician– Maintenance

Technicians– Change Coordinators– Trainers– Process Validation

Technicians


Production and Process Controls

• Written Instructions (SOP’s) Required• Environmental Controls

– Clean Rooms

• Personnel– Health, Cleanliness, etc.

• Contamination Control• Equipment

– Maintenance Schedules– Software Validation Required in Process Equipment


Inspection, Measurement and Test Equipment

• Routine Calibration of Measurement Equipment

• Reference Standards Must Be Maintained

• Records Must Be Kept In Secure Areas


Acceptance Activities

• Career Opportunities– Inspection Technician– Test Technicians– Non-conforming

product coordinator


Acceptance Activities

• Written Procedures are Required for all Inspection and Test Activities

• Receiving Inspection

• In-Process Inspection and Test

• Final Inspection and Test

• Records


Non-Conforming Product

• Non-conforming- Def: Does not meet Specifications

• Segregation, Identification and Status of Nonconforming Product is Required

• Material Review Board (MRB)

• Rework, Retest and Disposition


Typical Inspection, NCMR, and Rework Process(The Happy Path)

C:\ My Documents\ QA Training\ NCMR-Reprocess.abc

Incoming Inspection SP-00050 SP-00031

Accept/ Reject

In Process (WIP)

SP 00044 Travelers SP 00004 In-process

inspection

Accept/ Reject

Accept/ Reject

Finished Goods

Final QA Release

SP-00042

NCMR SP00022

Sort/ Rework ScrapReturn to

VendorUse As Is

Reprocess Order

Scrap Log

Vendor Notification Corrective

Action Request FM 00036

Re-Inspect

Return material to

Stores, in-process,

MRB

Stores SP00020 Material

control Process

Vendor replacement Debit Memo

FM00026

FM 00035Reject

FM 00029 Debit Memo

Special IP IP's

FM

FM 00032

00043

FM 00049 (MO)

QA Quarrentine

Material

Reject

Accept/ reject

Reject

Reject

Close NCMR File in Quality Data

files

Receive Correcive Action (CPAN or

Vendor CAR)

Accept

Use as is rationale

CPAR/ CPAN required?

NO

Yes

ECO Rework, Repair, Update

disposition


Corrective and Preventative Actions (CAPA)

• Career Opportunities– Quality Analyst– Quality Engineer– Complaint Coordinator



• Includes Internal and External Actions (Complaints to be covered after lunch)

• Corrective Actions- Actions Taken After Occurrence of the Event to Prevent Reoccurrence– Process Analysis– Failure Analysis – Procedure Review



• Examples of Corrective Actions– Review of Field Failures– Review of NCMR– Procedure Reviews

• Corrective Actions Should be Validated to Assure They Work



• Preventative Action- Actions Taken to Prevent a Problem from Occurring– Process Validations (IQ,OQ,PQ)– Trend Analysis of Complaints, Repairs – Internal Production Rework Trend Analysis

• (NCMR DATA)

– Supplier Audits and Reviews– Highly Accelerated Stress Screening Testing (HASS) – Highly Accelerated Life Testing (HALT)– Market Information Review from Competitors



• Communicate the Results of Analysis

• Management Reviews must Include CAPA Information

• Documentation of Actions is REQUIRED– Indication of the effectiveness of the Quality

System


Labeling and Packaging

• Written Procedures Required• Label Integrity-

– Does the label remain legible for product life• Label Inspection

– Control of labels required• Label Storage

– Secure area– QA release

• Labeling Operations– Assure that labels are not mixed up– Recalls of FDA regulated product can be initiated by mis-

labeling• Serial Numbers


Labeling and Packaging

• Packaging must be Designed to Assure That Products Are Protected During Transit and Storage– Shipping testing– Environmental testing (Temperature, Humidity)– Specialized labeling of the package may be

needed

• Sterile Packaging has Special Considerations


Handling, Storage, Distribution and Installation

• Career Opportunities– Material Handlers– Stockroom Personnel– Shipping Personnel– Field Installation– Traffic Managers



• Official Release (QA) from Production to Storage (Stockroom) Required

• Mix-Ups Must be Prevented

• Prevention from Damage or Deterioration– Shelf Life– Stock Control-FIFO



• Procedures Required to Assure that Only “GOOD” Product is Released for Distribution

• Records of Following must be Kept by Manufacturer– Name and Address of Consignee (Company or

Person who Receives Product)– Quantity shipped– Date Shipped– Serial, Lot Numbers Shipped



• Installation Instructions Required (IQ)

• Installation of Equipment Must Be Verified

• Records Kept (if done by Mfgr.)


Records

• General– Records Must be Legible– Security maintained– Available for Life of Product

• (min) 2 years past shipping date


Records• Device Master Record (DMR)( Recipe)

– Design Specifications– Process Specifications– QA Procedures– Packaging Info Records– Labeling Info– Installation and Maintenance Info

• Device History Record (DHR)(As really Built)– Date of Manufacture– Quantity Manufactured– Quantity Released for Distribution– Acceptance ( Test) Records– Primary Labeling Information

• Quality System Record (QSR)– Quality Manual, Management Review Procedures, SOP’s, Generic

Training Procedures, Other Non-device Specific Quality Procedures


Service

• Career Opportunities– Service Technicians


Service

• Written Procedure For Service Required• Testing Post Servicing Required

– Record is part of the DHR

• Records Must Contain– Name and SN of Device– Date and Person Servicing Device– Service preformed and Test Results

• Service Information Must Reviewed for Complaints


Statistical Techniques

• Valid Statistical Plans must be used for all sampling and testing to verify conformance to specifications


Class Exercise Manufacturing and Service

The Bright-Idea Company received approval to market the machine . They have produced approximately 1000 of the machines, shipped 700 to their customers.

One afternoon, the final tester began to notice that the machines did not always work the way they were supposed to at the final test station. He was rejecting about 50% of them.

The design engineer in charge found that there was a sticky valve in about 50% of one of the lots of valves they received two months ago. It was hard to tell if the valves would always fail or not, because the problem was intermittent.

350 machines had been made using the lot with the defective valves.

You are the Quality Engineer responsible for Corrective Actions. What steps should you take next?


Labeling

• Career Opportunities– Label Designer– Graphic Artist– Technical Writer


Labeling21 CFR 801

• Section 201(k) defines "label" as a:

"display of written, printed, or graphic matter upon the immediate container of any article..." The term "immediate container" does not include package liners. Any word, statement, or other information appearing on the immediate container must also appear "on the outside container or wrapper, if any there be, of the retain package of such article, or is easily legible through the outside container of wrapper."

• Section 201(m) defines "labeling" as:

"all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article" at any time while a device is held for sale after

shipment or delivery for shipment in interstate commerce.


Over The Counter (OTC)Device Labeling

• Principal Display Panel 21 CFR 801.60 The principal display panel is that portion of the label which is intended to be displayed, presented, shown, or examined under customary conditions for retail sales.

• Statement of Identity 21 CFR 801.61The statement of identity of the device must be listed on the principal display panel. – It must list the common name – Indications for use– Bold type, – Reasonably sized generally parallel to the base of the package

• Net Quantity of Contents Statement 21 CFR 801.62 The label of an over-the-counter (OTC) device in package form must contain a statement of net quantity of contents in terms of weight, measure, numerical count; or a combination of numerical count and weight, measure.


Prescription Device Labeling• Prescription Device 21 CFR 801.109 • A device which, because of any potentiality for harmful effect, or the supervision of

the method of its use, or the collateral measures necessary to its use is not safe unless under a practitioner licensed by law to direct use this device, and hence for which "adequate directions for use" cannot be written, is exempt from such provided:

– - It is in the possession of either a licensed practitioner or persons lawfully engaged in the manufacture of distribution of the product;

– - Its labeling bears an Rx statement, i.e., "Caution: Federal law restricts this device to sale by or on the order of a (Insert name of physician, dentist or other licensed practitioner;"

– - Its labeling bears information for use including, indications, effects, routes, methods, and frequency and duration of administration, and any relevant hazards, contraindications, side effects, and precautions under which the device can safely be used; and

– - All labeling other than labels and carton bears the date of issuance or date of the latest revision.


Rx Medical Device Labeling- General Requirements

• Intended Use• Indications for Use• Contraindications for Use• Warnings, Cautions• Description of the Device• User Instructions• Specifications• Corrective Actions (Troubleshooting)


FDA Actions for Mislabeling

• Warning Letters

• Mandatory Recall

• Injunctions to Stop Shipment

• Seizure

• Fines and Imprisonment


FDA Legal Actions• SEC. 303. [21 U.S.C. 333] (a)(1) Any person who violates a provision of section 301 shall be

imprisoned for not more than one year or fined not more than $1,000, or both.

• Notwithstanding the provisions of paragraph (1) of this section, if any person commits such a violation after a conviction of him under this section has become final, or commits such a violation with the intent to defraud or mislead, such person shall be imprisoned for not more than three years or fined not more than $10,000 or both.

• Knowingly distributing drugs/devices in violation of section 503(e)(2)(A), shall be imprisoned for not more than 10 years or fined not more than $250,000, or both.

• Any manufacturer or distributor who distributes drug/device samples by means other than the mail or common carrier whose representative, during the course of the representative’s employment or association with that manufacturer or distributor, violated section 301(t) because of a violation of section 503(c)(1) or violated any State law prohibiting the sale, purchase, or trade of a drug sample subject to section 503(b) or the offer to sell, purchase, or trade such a drug sample shall, upon conviction of the representative for such violation, be subject to the following civil penalties:

(A) A civil penalty of not more than $50,000 for each of the first two such violations resulting in a conviction of any representative of the manufacturer or distributor in any 10-year period.

(B) A civil penalty of not more than $1,000,000 for each violation resulting in a conviction of any representative after the second conviction in any 10-year period.


Class Exercise- Labeling

• Review of Respironics REMStar® Heated Humidifier labeling for:– Indications for use– Contraindications– Prescription Statement– Description– Corrective Actions


Complaints


Complaint Definitions

• Any written, electronic, or oral communication that alleges deficiencies related to the – Identity– quality– durability– reliability– safety– effectiveness– or performance

of a device after it is released for distribution."


World of Complaints

MDR

Incidents and near incidents

US EU

Some Definitions: Complaint: An expression of dissatisfaction concerning a product or services Quality Complaint: Any report that a product failed to meet its specifications for intended use, safety, performance or reliability; caused or contributed to a patient’s death; malfunctioned and could have caused or contributed to a death, or that the labeling was misleading or misbranding the product. Reportable Quality Complaints

US- Medical Device Reports- Report required if a death or serious injury occurred or could occur in similar circumstances due to a malfunction or improper labeling.


Sources of Complaints

Complaints that shall be processed according to the GMP requirements may be received from:

• Customers by letter, credit memo, returned goods form, or phone;

• A manufacturer's representative, or other employees;

• The MedWatch voluntary reporting program; • A service or repair request; • Journal articles; or • The FDA


What to do

1. Remain Calm 2. Gather details of the complaint:

a. Date complaint received, recipient’s name, recipient’s department, phone and extension number, if applicable.

b. Complainant’s information: name, address, telephone, and fax number if applicable.

c. Customer information: customer name, contact person, customer address, telephone, and fax number if applicable.

d. Patient information: patient name, date product placed in service, date of problem/event.

e. Device information: device name, model number, serial/lot number.

f. The form of communication of complaint: written, electronic, oral.

g. Details of complaint: Verify that enough information has been given in order that an analysis can be made of the type of complaint, specific malfunction or deficiency of product or service, or problem which has occurred.

h. If product has been returned, verify that an authorized RA number has been assigned

i. If the product has not been returned, try to have the product placed in Quarantine by the hospital, and arrange for return

j. Follow Up on Complaints k. Link to CAPA system


Complaints-MDR

• Medical Device Report (MDR)-The MDR regulation requires that all manufacturers of medical devices notify FDA when they become aware of a death or serious injury that may have been caused or contributed to by one of their marketed devices and/or any malfunction of one of their devices which, if it were to recur, would be likely to cause or contribute to a death or serious injury.


Class Exercise

Sandy Bright is Dr. Bright’s daughter. One day she was at a neighbor’s house (Ms. Consumer) when the machine Dr. Bright’s company made stopped working while Ms. Consumer was using it and Ms. Consumer had to go to the hospital. Ms. Consumer told Sandy to tell her Dad about the problem. Sandy told her Dad the next morning.

What Should Dr. Bright do and when?


FDA Audits


FDA Audits

• Career Opportunities– FDA Compliance

Officer– FDA Consumer Safety

Officer– Internal Auditor FDAFDA


FDA Audits of a Device Manufacturer

• Types– QSR-Risk Based Approach– Targeted- Based on a Complaint/Recall

• Establishment must be registered• May Be Unannounced• FDA issues a Form 482-Notice of Inspection• If problems- FDA issues a form 483-Notice of

Observations• Possible Warning Letter if not corrected.


Manufacturer’s Responsibilities

• Have Written Policy for FDA or other External Audits• Have Records Organized• Have an Escort at all Times• Have a Separate Room for the Auditor• Bring Information to Auditor• Be Courteous• Don’t offer any “bribes”

– Lunch– Trips to Hawaii– Baseball Game Tickets– Company Party


Employee Responsibility

• Remain Calm

• Answer Questions Truthfully

• Don’t Volunteer Information

• Refer to Procedures

• If in Doubt, Refer to Supervisor/Escort


Questions


Test