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Supplier Self Assessment_KO General Audit Module

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Worksheet 1: Table of Contents
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Page 1: Supplier Self Assessment_KO General Audit Module

Worksheet 1: Table of Contents

Page 2: Supplier Self Assessment_KO General Audit Module

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

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Page 3: Supplier Self Assessment_KO General Audit Module

Worksheet 2: Supplier Profile

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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

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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

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Worksheet 3: Stakeholders

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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

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Worksheet 4: Pre-Assessment

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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

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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

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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

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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

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Worksheet 5: Technical Information

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The Coca-Cola Company Supplier Assessment Workbook: Technical Information

To be populated with any additional technical information, as needed, by the assessor.

Technical Information

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Worksheet 6: Assessment

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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

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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

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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

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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

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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

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Page 21: Supplier Self Assessment_KO General Audit Module

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

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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

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Worksheet 7: Definitions

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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

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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

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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

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