Upload
sharadpc
View
68
Download
6
Embed Size (px)
Citation preview
Worksheet 1: Table of Contents
The Coca-Cola Company Supplier Quality Self Assessment Workbook
The scope of this assessment covers your quality system, GMPs and food safety program, and its purpose is to establish/maintain your authorization to supply customers in
the Coca-Cola system. The supplier authorization process is based on the requirements as stated in the Supplier Expectations brochure.
The following spreadsheets, "Coca-Cola Supplier Quality Assessment Workbook", contain all of the information you need to prepare for this assessment.
Pre-Assessment
The information requested on these Pre-Assessment tabs MUST be submitted in order for the assessment to occur. Failure to submit these items will result in a cancellation of
the assessment, and ultimately, a loss of authorization to supply materials to The Coca-Cola system.
Supplier Profile - Fill in all fields
Stakeholders - Please list contact information for your raw material suppliers and Coca-Cola system customer plants.
Pre-Assessment - Read sheet. Submit requested documents to auditor.
Technical Information - Read sheet. To be populated with any additional technical information, as needed, by the assessor.
Assessment Form - As directed on the pre-assessment tab (row 46-48), use this list of audit questions to evaluate yourself in advance, and close any gaps prior to the visit, if
possible. Using the Rating Key choose a rating in column 'E' (see Definitions tab) for each audit question, and the sheet will score itself. Each audit question should have
either a brief nonconformance description in column 'F', or a reference to the objective evidence that the requirement has been met in column 'G'. Do not attach the
documents, etc. The assessor will review them on-site.
Assessment
Assessment Form - Your auditor will utilize this sheet to evaluate your facility.
Report Summary - Report generating form. Summarized score and quantity of findings by Supplier Expectations Brochure Requirements.
CAP - Corrective action plan, which is required to be closed out for all findings, regardless of authorization status.
Authorization Letter - The supplier facility is granted the following authorization status as a supplier to the Coca-Cola Company:
Supporting Information
Definitions - Definitions for the different rating categories.
Table of Contents
page 2 of 26
Worksheet 2: Supplier Profile
The Coca-Cola Company Supplier Assessment Workbook: Supplier Profile
(All sections must be completed for an assessment to be performed)
Company Name: City, ST (or City, Country): Assessor: Assessment Date:
January 1, 2011
Street address: Zip Code or Postal Code: Phone : Fax :
Who from your facility will be involved in this assessment process? (insert rows as necessary)
Name Title / job position Phone number Email
Who from your corporate office will be involved in this assessment process? (insert rows as necessary)
Name Title / job position Phone number Email
Products currently manufactured for The Coca-Cola Company (insert rows as necessary)
Type of Material Description of Ingredient / Package Container Type Ship-To Location(s)
Supplier Profile
page 4 of 26
Products potentially manufactured for The Coca-Cola Company (insert rows as necessary)
Type of Material Description of Ingredient / Package Container Type Ship-To Location(s)
FDA Registration Number (Bioterrorism):
List all third party audits performed at this facility
(e.g., AIB, GMA-SAFE, Silliker, etc.):
List all certifications for the facility
(e.g., ISO, HACCP, Kosher, Halal, Organic, etc.):
List any Big 8 allergens, sulfites, or FD&C Yellow No. 5
that could be present at this facility:
Describe how lot numbers are assigned to finished product:
Describe the source of process water (well, municipality, condensate), as well as effluent
treatment and destination:
Relative to other customers of this facility, the volume shipped to the Coca-Cola system (all above locations combined) is: Minor (<25%)
GFSI Certification Status (applicable for all suppliers): Not Aware of Requirement
GFSI Scheme:
Date Completed or Scheduled:
Rating:
Third Party Auditor:
Supplier Guiding Principles Status (applicable for suppliers with annual volumes above $60,000): Not Eligible (<$60k)
Date Completed or Scheduled:
Rating:
Third Party Auditor:
Supplier Profile
page 5 of 26
Worksheet 3: Stakeholders
Supplier Assessment Workbook: Stakeholders
(Both sections must be completed for an assessment to be performed)
Please list your raw materials and the facilities that supply them: (insert rows as necessary)
Material Description Supplier Company City, State Phone number
Please list your primary customer contact at each ship-to location listed on the previous tab: (insert rows as necessary)
Name Title or Job Position & Location Phone number Email
For post-audit communications, please list email addresses for the following stakeholders (one cell per group, emails separated by semi-colon)
Your Corporate / Local Representatives Coca-Cola Procurement Representatives Customer Contacts (above)
Stakeholders
page 7 of 26
Worksheet 4: Pre-Assessment
The Coca-Cola Company Supplier Assessment Workbook: Pre-Assessment
Please provide the following four items by the assessor's requested date. Completion of this Pre-assessment will be scored as requirement M.0.2 in the Core
Assessment checklist.
1.) Process Flow Diagram
A diagram which shows the major steps in your manufacturing process and identifies the points in the process where quality control parameters are measured. Diagrams do
not have to be engineering drawings, but should at least give an idea of physical line layout. Please paste a digital image or scanned drawing here:
Pre-Assessment
page 9 of 26
2.) Quality Control Plan/Matrix
A summary of all quality control points labeled in your process flow diagram, with the following information for each: frequency of measurement or testing, sample size, test
method (provide SOP number), specification or acceptable range, and what action is taken (and by whom) if the result is unsatisfactory. If your documented quality control plan
contains all of this information, please attach it separately in an email to your assessor. If not, you may use the table below (insert rows as necessary):
Quality Control Point Frequency Sample Size Test Method (SOP #)Spec or Acceptable
Range
Action Plan
Pre-Assessment
page 10 of 26
3.) Coca-Cola Customer Quality Issues and Corrective Action Program
List each complaint from your Coca-Cola system customers within the last 12 months (applies to existing suppliers). For each, include the corrective actions taken, the status
of the complaint, and verifications that any completed corrective actions have been effective in resolving the issue. If your documented corrective action reports contain all of
this information, please attach these separately in an email to your assessor. If not, you may use the table below (insert rows as necessary):
Date Customer Issue Corrective Action Verification Status
Pre-Assessment
page 11 of 26
4.) Self Assessment (Scored as Requirement M.2)
Using the Assessment tab, complete a self-assessment by entering one of the following ratings in the appropriate cells: NF (no finding), IO (improvement opportunity), PR
(potential risk), HR (high risk), CR (critical risk), or NA (not applicable). Definitions for each of these ratings can be found on the Definitions tab. Each requirement mustreceive a rating in column E; it must also list either a description of any nonconformance (column F) or of the objective evidence which will be produced duringthe assessment to demonstrate compliance (column G).
Pre-Assessment
page 12 of 26
Worksheet 5: Technical Information
The Coca-Cola Company Supplier Assessment Workbook: Technical Information
To be populated with any additional technical information, as needed, by the assessor.
Technical Information
page 14 of 26
Worksheet 6: Assessment
The Coca-Cola Company Supplier Assessment Workbook: Core Assessment
OVERALL ASSESSMENT SCORE: 100.0%
Ref # Questions (Supplier Expectations) Max Earned Rating Brief Nonconformance Description Objective Evidence
A. QUALITY SYSTEM 100%
A.1
Is there a documented quality system in place with well-
defined objectives and metrics?
20 20 NF
A.2
Is management involved in the effectiveness review of the
quality system?
5 5 NF
A.3
Is there a system in place to manage critical procedures and
records?
5 5 NF
A.4
Does the Supplier have an effective internal quality audit
system, conducted by appropriate auditors?
10 10 NF
A.5 Has a customer satisfaction procedure been established? 5 5 NF
A.6
Is the Supplier in compliance with one of the recognized GFSI
schemes? If not, is certification scheduled within the next 12
months?
5 5 NF
B. QUALITY PROGRAMS 100%
B.1 Conformance to Specifications 100%
B.1
Does the supplier understand and meet the relevant Coca-Cola
Company technical requirements?
10 10 NF
B.2 Good Manufacturing Practices 100%
B.2.1
Are there documented Good Manufacturing Practices in place
describing the rules for sanitary practices and hygiene for all
personnel?
25 25 NF
B.2.2
Are the facility conditions adequate for food ingredients / food
packaging manufacturing?
25 25 NF
B.3 Good Laboratory Practices 100%
B.3.1
Are testing facilities and equipment adequate for the degree of
accuracy required ?
10 10 NF
B.3.2 Are the current testing methods documented and validated? 10 10 NF
B.3.3
Are reagent solutions, reactants and standards handled
properly?
5 5 NF
B.4 Personnel Training 100%
B.4.1 Is there an employee training program in place? 10 10 NF
Assessment
page 16 of 26
B.4.2
Is there a training program for temporary and contract
employees covering the aspects of the job they are
performing, as well as essential aspects of the quality, food
safety, security and GMP programs.
5 5 NF
B.4.3
Are all permanent employees trained and qualified prior to
performing their assigned duties?
5 5 NF
B.4.4
Is there a system in place (e.g. evaluations) to verify the
effectiveness of the training program?
5 5 NF
B.5 Pest Control 100%
B.5.1 Is there a documented Pest Control program in place? 20 20 NF
B.5.2 Are insecticides and rodenticides used appropriately? 10 10 NF
B.6 Housekeeping and Sanitation Controls 100%
B.6.1
Has the Supplier implemented an adequate cleaning and
housekeeping program?
20 20 NF
B.6.2
Is there a system for verifying the effectiveness of the
sanitation program that includes microbial and cross
contamination?
10 10 NF
B.7 Facilities and Equipment Design 100%
B.7.1
Is the facility design adequate for food ingredients / food
packaging manufacturing?
20 20 NF
B.7.2
Is equipment designed to reduce the risk of inadvertent
contamination?
40 40 NF
B.8 Record Keeping 100%
B.8.1
Are systems in place for managing and controlling quality
system data and records?
10 10 NF
B.8.2 Is there a record retention schedule and is it followed? 10 10 NF
B.8.3
Are records accurate and legible, and are proper procedures
used for making corrections?
10 10 NF
B.9 Corrective and Preventive Action 100%
B.9.1
Does the supplier have a systematic approach or program for
all corrective and preventive actions, from both external and
internal sources (non-conformances, complaints, internal and
external audit deviations, customer complaints)?
20 20 NF
B.9.2
Does the process include identification of issue, investigation
of root cause, timely corrective action, and follow-up to
confirm implementation and effectiveness?
10 10 NF
Assessment
page 17 of 26
B.9.3
Is internal data or customer satisfaction data (previously
mentioned in A.2) used to evaluate the effectiveness of the
corrective action program and continuous improvement
efforts?
10 10 NF
B.9.4
Does the Supplier have a copy of the most recent TCCC
assessment and the associated corrective action plan?
5 5 NF
B.9.5
Can the Supplier demonstrate the effectiveness of its
corrective action program by the proper completion of all
items from previous assessments by TCCC?
50 50 NF
C. SUPPLIER GUIDING PRINCIPLES 100%
C.1
Has the supplier had a Supplier Guiding Principles Audit (third
party social compliance) performed in the last three years or
scheduled within the next calendar year on behalf of TCCC?
The Supplier Guiding Principles are available at:
http://www.thecocacolacompany.com/citizenship/supplier_gui
ding_principles.html .
10 10 NF
D. PURCHASED MATERIALS/ SERVICES 100%
D.1
Does the supplier have a defined program to approve and
monitor the performance of suppliers and purchased materials
/ services?
20 20 NF
D.2 Is there an effective incoming inspection program in place? 10 10 NF
D.3
If supplier is subcontracting part of the manufacturing
process, is there a procedure in place to audit the third party
operations and ensure quality and process control?
10 10 NF
E. PROCESS MONITORING AND CONTROL 100%
E.1 Process Control 100%
E.1.1
Has the supplier clearly defined the key process control points
and monitoring frequencies used to convert raw materials into
finished products?
20 20 NF
E.1.2
Are the accept/reject criteria and responsibilities clearly
defined for each control point?
20 20 NF
E.1.3 Are the process control points being properly monitored? 20 20 NF
E.1.4
Do current and historical test results, as well as process
control data, demonstrate that the supplier is capable of
consistently producing products within the specifications of
The Coca-Cola Company?
20 20 NF
E.2 Calibration Controls 100%
Assessment
page 18 of 26
E.2.1
Does the supplier have a formal calibration program in place
that identifies critical equipment?
10 10 NF
E.2.2
Is test equipment calibrated at regular intervals, and are
adequate records of these calibrations kept?
10 10 NF
E.2.3 Are the calibration frequencies reasonable? 5 5 NF
E.2.4
Are calibration standards appropriate and traceable to national
standards?
5 5 NF
E.2.5
When applicable, are critical equipment (scales, inline
detectors, etc.) verified at documented intervals? Are records
of verifications properly documented?
10 10 NF
E.3 Weight \ Fill Controls 100%
E.3.1
Does the supplier have a method to ensure that shipments to
TCCC are of accurate quantity?
5 5 NF
E.4 Preventive and Corrective Maintenance Program 100%
E.4.1
Is there an effective maintenance program in place that
identifies critical equipment, monitors performance, and
schedules routine maintenance?
10 10 NF
E.4.2
Are corrective maintenance records reviewed to define the
need for preventive maintenance activities?
10 10 NF
F. FINISHED PRODUCT MANAGEMENT 100%
F.1 Finished Product Management 100%
F.1.1 Is there a stock management procedure in place? 10 10 NF
F.1.2
When required, are Certificates of Compliance or Analysis
issued to TCCC manufacturing sites for all materials?
10 10 NF
F.2 Design of Storage Facilities 100%
F.2.1
Are storage facilities designed and maintained in a way to
guarantee adequate storage conditions (protection from dust,
condensation, drains, waste, temperature changes and other
sources of contamination)?
10 10 NF
F.2.2
If third party storage is used, is there a process in place to
select, contract and monitor the service?
10 10 NF
F.3 Transportation 100%
F.3.1
Are there procedures in place to ensure transportation
conditions do not affect the product?
10 10 NF
F.4 Non-Conforming Product 100%
F.4.1
Has the supplier implemented an adequate non-conforming
product segregation procedure?
20 20 NF
G. FOOD SAFETY MANAGEMENT 100%
G.1Has a HACCP food safety management program been defined
and implemented?
40 40 NF
Assessment
page 19 of 26
G.2Is there an adequate process flow diagram, and has a formal
hazard analysis been conducted?
20 20 NF
G.3 Are Critical Control Points identified and monitored? 20 20 NF
G.4
Adequate pre-requisite programs (water quality, pest control,
cross contamination, employee practices, etc.) have been
formalized and verified?
20 20 NF
G.5Is there an allergen program in place, with procedures to
prevent cross-contamination of products?
20 20 NF
H. CHEMICAL RESIDUE AND CONTAMINATION CONTROL 100%
H.1
Does the supplier have an effective program for receiving,
handling, identifying (labeling), segregating, storing and use
non-food chemical agents (e.g. cleaning and sanitizing
products, water treatment chemicals, refrigerants, and
lubricants)?
20 20 NF
H.2
Is there a list of permitted chemical agents, and is it used to
ensure that only permitted substances (including cleaning
products) and additives are used when they could possibly
contact the product?
5 5 NF
H.3
Are utilities (air, water, steam, etc.) of the appropriate quality
for their application (to be defined by the supplier)?
10 10 NF
H.4
Are pallets of the appropriate quality and free from potential
contaminants?
20 20 NF
I. TRACEABILITY 100%
I.1
Is there an effective system in place to guarantee full backward
and forward traceability?
20 20 NF
I.2
Does the traceability procedure include the regular completion
of mock recalls (annually of more often if required by
customer)?
10 10 NF
I.3
Can the traceability system effectiveness be demonstrated
through a traceability exercise or mock recall data?
20 20 NF
I.4
Can traceability records be linked to the relevant quality and
process data?
10 10 NF
J. SCIENTIFIC AND REGULATORY AFFAIRS 100%
J.1
Has the supplier implemented a process to consistently ensure
compliance to all applicable regulatory requirements?
10 10 NF
J.2
Where required, are Certificates of Regulatory Compliance
supplied to Coca-Cola Bottlers and The Coca-Cola Company
for all food contact materials?
10 10 NF
Assessment
page 20 of 26
K. REGULATORY ACTION NOTIFICATION 100%
K.1
Has the supplier implemented a procedure to notify the Coca-
Cola Company and any receiving locations when any product
or component produced for The Coca-Cola System is directly
or indirectly the subject of:
- A regulatory action,
- A product recall, or
- When there is an event that could create adverse publicity to
The Coca-Cola System ?
5 5 NF
K.2
In case products or components produced for The Coca-Cola
Company are sampled by a Regulatory Authority at the
supplier premises, is there a procedure in place to obtain
duplicate samples?
5 5 NF
K.3
Does the supplier have a current Coca-Cola and customer
contact list that will allow 24/7 access to key individuals at
receiving location to support the notification requirements
above?
5 5 NF
L. CHANGE CONTROL MANAGEMENT PROCESS 100%
L.1
Does the supplier have a documented and implemented
change control management process that ensures changes
impacting product quality are reviewed, verified and approved
before implementation?
20 20 NF
L.2
Does the supplier have a system to notify the customer and
the Coca-Cola Company functions when any changes occur to
the following:
- manufacturing processes,
- manufacturing locations,
- product packaging,
- raw materials or components,
- product specifications, or
- company or facility ownership?
10 10 NF
M. ASSESSOR ACCESS 100%
M.1
Does the supplier allow the assessor to all areas and
information that is needed to reasonably conduct this
assessment?
10 10 NF
M.2
Were all 4 sections of the pre-assessment satisfactorily
completed?
30 30 NF
N. SECURITY / FOOD DEFENSE 100%
N.1
Does the supplier have documented security procedures and
policies, and are they adequate?
20 20 NF
Assessment
page 21 of 26
N.2 Are the facilities secure from unauthorized access? 20 20 NF
N.3
Does the supplier properly maintain control of the TCCC
Trademark by ensuring all scraps, damaged, or obsolete
trademark materials are destroyed?
10 10 NF
N.4
Does the supplier properly secure confidential information
concerning products used by TCCC?
10 10 NF
O. LEGAL CONTRACTS 100%
O.1
If required, has the supplier signed a Supplier Authorization
Agreement?
5 5 NF
P. COMPLIANCE WITH LAWS 100%
P.1
Is there a procedure in place to ensure goods and services
supplied to the Coca-Cola system comply to applicable laws
and regulations ?
5 5 NF
Q. CONFIDENTIALITY 100%
Q.1
Does the supplier have a signed Non-Disclosure agreement
with The Coca-Cola Company?
5 5 NF
R. CODE OF BUSINESS CONDUCT 100%
R.1
Is the supplier familiar with TCCC Code of Business Conduct
for Suppliers (a copy of the document is available at
http://www.thecoca-colacompany.com/ our
company/business_conduct.html)?
5 5 NF
TOTAL 1090 1090
Assessment
page 22 of 26
Worksheet 7: Definitions
Authorization Criteria and Risk Definitions
Full Authorization CriteriaScore at least 90.0 on overall assessment, ANDPass each of the following sections: A: QUALITY SYSTEM, B: QUALITY PROGRAMS, C: SUPPLIER GUIDING PRINCIPLES, E:PROCESS MONITORING AND CONTROL, G: FOOD SAFETY, N: SECURITY, ANDFail no more than one of the other sections
Conditional Authorization CriteriaScore at least 70.0 on overall assessment, ANDFail no more than 4 of the other sections
Limited Authorization CriteriaScore at least 50.0 on overall assessment, ANDFail no more than 4 of the other sections
Not Authorized CriteriaScore less than 50.0 on overall assessment, ORFail 5 or more sections
Critical Risk (CR)Any finding or structural shortcoming in the quality system that could:
–Create a major health and/or safety concern, requiring production to be stopped immediately and market place actions initiated and/or–Result in a major public relations embarrassment or regulatory intervention, thereby putting severely The Company’s integrity orreputation at risk and/or–Significantly reduce or eliminate current or future sales and/or–Significantly reduce or eliminate the financial results of the operation–The business risk to the Company or the operation is critical.
–Items are ranked as critical risk if, on further investigation, it is found that both the preventative and detective controls are inadequate. –Corrective action needs to be initiated immediately and completed before material is purchased from the supplier site.
Definitions
page 24 of 26
High Risk (HR)Any finding or structural shortcoming in the quality system that could: –Create a health and/or safety concern and/or –Result in public relations embarrassment thereby putting The Company’s integrity or reputation at risk and/or –Reduce current or future sales and/or –Reduce the financial results of the operation–The business risk to the Company or the operation is high.
–Items are ranked as high risk if, on further investigation, it is found that either the preventative or detective controls are inadequate. –A number of high risk findings, when reviewed collectively, may present a critical risk to the operation. In these instances, the leadauditor may deem it appropriate to present these collective high risks as a critical risk finding. –Corrective action needs to be initiated immediately before materials are purchased from the supplier site.
Potential Risk (PR)–Any finding that has a current or potential high impact on quality (the finding can be isolated or systematic). –Any structural shortcoming in a quality system element. –The business risk to the Company or the operation is currently not significant. –A number of potential risk findings, when reviewed collectively, may present a high risk to the operation. In these instances, the LeadAuditor may deem it appropriate to present these collective potential risks as a high risk finding. –Corrective action should be as a priority by the supplier and a condition of future purchases from the supplier site.
Improvement Opportunity (IO)–Any low impact finding (isolated or systemic), which is not a structural shortcoming to a quality system element. –Any issue where there is no evidence of bad results, but where the system does not provide enough guarantee for consistent effectiveperformance. –Any situation where the current system meets the requirements of TCCQS but there is an important opportunity for efficiencyimprovement
–A number of improvement opportunities, when reviewed collectively, may present a potential risk to the operation. In these instances,the Lead Auditor may deem it appropriate to present these collective improvement opportunities as a potential risk finding. –The finding should be included in the audit report of the supplier operation.
Definitions
page 25 of 26
Not Applicable (NA) Any specific audit question that does not apply to this location.
Not Reviewed (NR) Any specific audit question that was not evaluated.
No Finding (NF)No finding for this specific audit question. Everything appears to be in order.
Definitions
page 26 of 26