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Table of Contents
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.
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Supplier Profile
January 1, 2011
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)
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Supplier Profile
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:
Supplier Guiding Principles Status (applicable for suppliers with annual volumes above $60,000):
Date Completed or Scheduled: Rating: Third Party Auditor:
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Worksheet 3: Stakeholders
Stakeholders
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)
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Worksheet 4: Pre-Assessment
Pre-Assessment
page 9 of 26
Pre-Assessment
page 10 of 26
Pre-Assessment
Date
Customer
Issue
Corrective Action
Verification
Status
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Pre-Assessment
page 12 of 26
Technical Information
page 14 of 26
Worksheet 6: Assessment
Assessment
Is the Supplier in compliance with one of the recognized GFSI schemes? If not, is certification scheduled within the next 12 months? B. QUALITY PROGRAMS B.1 Conformance to Specifications Does the supplier understand and meet the relevant Coca-Cola B.1 Company technical requirements? B.2 Good Manufacturing Practices Are there documented Good Manufacturing Practices in place B.2.1 describing the rules for sanitary practices and hygiene for all personnel? Are the facility conditions adequate for food ingredients / food B.2.2 packaging manufacturing? B.3 Good Laboratory Practices Are testing facilities and equipment adequate for the degree of B.3.1 accuracy required ? B.3.2 Are the current testing methods documented and validated? Are reagent solutions, reactants and standards handled properly? B.4 Personnel Training B.4.1 Is there an employee training program in place? B.3.3
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Assessment
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. Are all permanent employees trained and qualified prior to performing their assigned duties? Is there a system in place (e.g. evaluations) to verify the effectiveness of the training program? B.5 Pest Control Is there a documented Pest Control program in place? Are insecticides and rodenticides used appropriately? B.6 Housekeeping and Sanitation Controls Has the Supplier implemented an adequate cleaning and housekeeping program? Is there a system for verifying the effectiveness of the sanitation program that includes microbial and cross contamination? B.7 Facilities and Equipment Design Is the facility design adequate for food ingredients / food packaging manufacturing? Is equipment designed to reduce the risk of inadvertent contamination? B.8 Record Keeping Are systems in place for managing and controlling quality system data and records? Is there a record retention schedule and is it followed? Are records accurate and legible, and are proper procedures used for making corrections? B.9 Corrective and Preventive Action
NF
5 5 20 10 20 10
5 5 20 10 20 10
B.7.1 B.7.2
20 40
20 40
NF NF 100%
10 10 10
10 10 10
NF NF NF 100%
Does the supplier have a systematic approach or program for all corrective and preventive actions, from both external and B.9.1 internal sources (non-conformances, complaints, internal and external audit deviations, customer complaints)? Does the process include identification of issue, investigation B.9.2 of root cause, timely corrective action, and follow-up to confirm implementation and effectiveness?
20
20
NF
10
10
NF
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Assessment
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
Does the Supplier have a copy of the most recent TCCC assessment and the associated corrective action plan? Can the Supplier demonstrate the effectiveness of its B.9.5 corrective action program by the proper completion of all items from previous assessments by TCCC? C. SUPPLIER GUIDING PRINCIPLES B.9.4 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 . D. PURCHASED MATERIALS/ SERVICES Does the supplier have a defined program to approve and monitor the performance of suppliers and purchased materials / services? Is there an effective incoming inspection program in place? 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?
5 50
5 50
NF NF 100%
C.1
10
10
NF
100% 20 10 20 10 NF NF
D.1 D.2
D.3
10
10
NF 100% 100%
E. PROCESS MONITORING AND CONTROL E.1 Process Control Has the supplier clearly defined the key process control points E.1.1 and monitoring frequencies used to convert raw materials into finished products? Are the accept/reject criteria and responsibilities clearly E.1.2 defined for each control point? E.1.3 Are the process control points being properly monitored? Do current and historical test results, as well as process control data, demonstrate that the supplier is capable of E.1.4 consistently producing products within the specifications of The Coca-Cola Company? E.2 Calibration Controls
20 20 20
20 20 20
NF NF NF
20
20
NF 100%
page 18 of 26
Assessment
E.3.1
E.4.1 E.4.2
F.1.1 F.1.2
Does the supplier have a formal calibration program in place that identifies critical equipment? Is test equipment calibrated at regular intervals, and are adequate records of these calibrations kept? Are the calibration frequencies reasonable? Are calibration standards appropriate and traceable to national standards? When applicable, are critical equipment (scales, inline detectors, etc.) verified at documented intervals? Are records of verifications properly documented? E.3 Weight \ Fill Controls Does the supplier have a method to ensure that shipments to TCCC are of accurate quantity? E.4 Preventive and Corrective Maintenance Program Is there an effective maintenance program in place that identifies critical equipment, monitors performance, and schedules routine maintenance? Are corrective maintenance records reviewed to define the need for preventive maintenance activities? F. FINISHED PRODUCT MANAGEMENT F.1 Finished Product Management Is there a stock management procedure in place? When required, are Certificates of Compliance or Analysis issued to TCCC manufacturing sites for all materials?
10 10 5 5 10
10 10 5 5 10
NF NF NF NF NF 100%
NF 100%
10 10
10 10
10 10
10 10
F.2 Design of Storage Facilities Are storage facilities designed and maintained in a way to guarantee adequate storage conditions (protection from dust, F.2.1 condensation, drains, waste, temperature changes and other sources of contamination)? If third party storage is used, is there a process in place to select, contract and monitor the service? F.3 Transportation Are there procedures in place to ensure transportation F.3.1 conditions do not affect the product? F.4 Non-Conforming Product Has the supplier implemented an adequate non-conforming F.4.1 product segregation procedure? G. FOOD SAFETY MANAGEMENT Has a HACCP food safety management program been defined G.1 and implemented? F.2.2
10
10
NF
10
10
NF 100%
10
10
NF 100%
20
20
NF 100%
40
40
NF
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Assessment
Is there an adequate process flow diagram, and has a formal hazard analysis been conducted? Are Critical Control Points identified and monitored? Adequate pre-requisite programs (water quality, pest control, cross contamination, employee practices, etc.) have been formalized and verified? Is there an allergen program in place, with procedures to prevent cross-contamination of products? H. CHEMICAL RESIDUE AND CONTAMINATION CONTROL 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)? 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? Are utilities (air, water, steam, etc.) of the appropriate quality for their application (to be defined by the supplier)? Are pallets of the appropriate quality and free from potential contaminants? I. TRACEABILITY Is there an effective system in place to guarantee full backward and forward traceability? Does the traceability procedure include the regular completion of mock recalls (annually of more often if required by customer)? Can the traceability system effectiveness be demonstrated through a traceability exercise or mock recall data? Can traceability records be linked to the relevant quality and process data? J. SCIENTIFIC AND REGULATORY AFFAIRS Has the supplier implemented a process to consistently ensure compliance to all applicable regulatory requirements? Where required, are Certificates of Regulatory Compliance supplied to Coca-Cola Bottlers and The Coca-Cola Company for all food contact materials?
20 20 20 20
20 20 20 20
NF NF NF NF 100%
H.1
20
20
NF
H.2
NF
H.3 H.4
10 20
10 20
NF NF 100%
I.1 I.2
20 10
20 10
NF NF
I.3 I.4
20 10
20 10
NF NF 100%
J.1
10
10
NF
J.2
10
10
NF
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Assessment
K. REGULATORY ACTION NOTIFICATION Has the supplier implemented a procedure to notify the CocaCola 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 ? 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? 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? L. CHANGE CONTROL MANAGEMENT PROCESS 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? 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? M. ASSESSOR ACCESS Does the supplier allow the assessor to all areas and information that is needed to reasonably conduct this assessment? Were all 4 sections of the pre-assessment satisfactorily completed? N. SECURITY / FOOD DEFENSE Does the supplier have documented security procedures and policies, and are they adequate?
100%
K.1
NF
K.2
NF
K.3
NF 100%
L.1
20
20
NF
L.2
10
10
NF
100% 10 30 10 30 NF NF 100% 20 20 NF
M.1 M.2
N.1
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Assessment
O.1
P.1
Q.1
R.1
Are the facilities secure from unauthorized access? Does the supplier properly maintain control of the TCCC Trademark by ensuring all scraps, damaged, or obsolete trademark materials are destroyed? Does the supplier properly secure confidential information concerning products used by TCCC? O. LEGAL CONTRACTS If required, has the supplier signed a Supplier Authorization Agreement? P. COMPLIANCE WITH LAWS Is there a procedure in place to ensure goods and services supplied to the Coca-Cola system comply to applicable laws and regulations ? Q. CONFIDENTIALITY Does the supplier have a signed Non-Disclosure agreement with The Coca-Cola Company? R. CODE OF BUSINESS CONDUCT 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)? TOTAL
20 10 10
20 10 10
NF NF NF 100%
NF 100%
NF 100%
NF 100%
5 1090
5 1090
NF
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Worksheet 7: Definitions
Definitions
page 24 of 26
Definitions
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 Companys 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 lead auditor 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 Lead Auditor 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 effective performance. Any situation where the current system meets the requirements of TCCQS but there is an important opportunity for efficiency improvement 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.
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Definitions
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.
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