1、January 2003 Quality Systems Audit Page 1 Yum! Brands GLOBAL RESTAURANTS, INC. (A&W, KFC, Long John Silvers, Pizza Hut, and Taco Bell) QUALITY SYSTEMS ASSESSMENT GUIDELINES 2006 version These Guidelines are for use with Yum! Brands Quality Systems Assessment and in Supplier Approval Evaluations. Ite
2、ms in BOLD PRINT are Automatic Failures for No points categories. Those elements not applicable to the supplier shall be designated as n/a on the score sheet. Each question scoring an Automatic Failure or No Points score is to have a corrective action inserted into the Action Plan section of the sco
3、re sheet. The action plan is to be completed with the suppliers input. If a suppliers process or product makes it impossible to meet standards exactly as written, the supplier may request a Letter of Variance from Yum! Brands. A Letter of Variance is issued only under extreme circumstances, and only
4、 if the Yum! Brands QA department agrees a variance is warranted. The document shall be signed by appropriate Yum! Brands QA contact then forwarded to the supplier. All Letters of Variance must be maintained on file at the supplier and updated at a minimum of annually. Variances received the day of
5、the assessment will not count for the current assessment, but will be included in future assessments. Yum! Brands Global Restaurants reserves the right to follow-up on all corrective actions noted in the Quality Systems Assessment. Points noted in parenthesis - ex: (10 points) - represent points ear
6、ned. (*) - Questions designated with an asterisk may be scored n/a for first time audits only. Assessment Sections: Category means the section to be assessed (ex: 1.0, 2.0, etc.) Element is the specific bulleted requirement within the category (ex: 1.1, 1.2, etc.). Criteria is the explanation of eac
7、h audit point. For the purposes of this assessment: single occurrence = refers to one instance isolated occurrences = refers to two or three instances numerous occurrences = refers to more than three instances up to systematic systematic failure = refers to repeated instances of numerous occurrences
8、 over several days maintained = means kept up-to-date and on file at the facility established = means written and implemented program/procedures = refers to written methods, techniques, practices, policies, etc. documentation = refers to established documents supplied to verify Guideline requirement
9、s. records = refer to the actual data collected and maintained, based on the criteria outlined in the procedures. Auditor is to review between1% and 10% January 2003 Quality Systems Audit Page 2 of records since the last assessment, enough to get a representative sample. If issues are found, an addi
10、tional sample of records should be reviewed to determine if the issue is isolated or reoccurring. All record corrections shall be single lined out (so that the correction can still be read) and initialed. White-out shall not be used in correcting records. analytical tests = refers to the chemical, m
11、icrobiological or instrumental physical testing used to verify compliance to specification. These tests can be performed by QA, manufacturing or the laboratory. In certain situations, multiple questions may be marked for the same finding. The Yum! Brands representative shall use their judgment and r
12、ecord the finding under the most appropriate audit point. Circumstances, however, may warrant the Yum! Brands representative to mark down the issue in multiple locations. It is important to understand that local laws and practices may differ from certain guidelines. In all cases, the more complete o
13、r restrictive will prevail. It is important the Yum! Brands representative realize these differences and evaluate the supplier accordingly. _ Quality Systems Assessment Guidelines 1.0 PRODUCT QUALITY 1.1(*) Conformance to specification/formulation is measured at the sample size, frequency and by the
14、 method indicated in the Yum! Brands Product Quality Assurance Program. (Records) All points (15 points): The inspection methods and frequencies outlined in the Yum! Brands Product Quality Assurance Program and specifications are measured as defined. Any variance to Yum! Brands Quality Assurance Pro
15、gram or specification requirements shall require a Letter of Variance from the appropriate Yum! Brands Quality contact. Every point in the Quality Assurance Program should have an associated record to verify that the requirement was met. The following will constitute full points: records are consist
16、ent with methods and frequencies in Yum! Brands QAP supplier-developed quality programs were pre-approved in writing by the appropriate Yum! Brands QA contact and include: Yum! Brands specification KPIs in the routine quality monitoring. Review a minimum of 1% of records since last Quality Systems A
17、ssessment. If issues are found, additional records shall be reviewed. The Quality Assurance Program(s) should be used while reviewing records to verify compliance to requirements. Minor non-conformance (10 points): One of the following will constitute a minor non-conformance: correct and current met
18、hods used, but isolated instances of missed inspections or timings are observed January 2003 Quality Systems Audit Page 3 one quality control point is not monitored at the prescribed frequency or by the proper method without a Letter of Variance Major non-conformance (5 points): One of the following
19、 will constitute a major non-conformance: the correct methods are being used, but there are numerous instances of missed inspections or timings two quality control points are not monitored at the prescribed frequency or by the proper method without a letter of Variance records contain numerous omiss
20、ions the sample size has been reduced without a Letter of Variance one quality control point is not monitored the suppliers Quality Program has not been pre-approved, in writing, by the appropriate Yum! Brands QA contact. No points: No points will be awarded if any one of the following is encountere
21、d: incorrect methods used to monitor the process systematic failure of inspection frequency meeting QAP Guidelines systematic failure to maintain records deviations in frequency or method which could allow or has allowed non-conforming product to pass into the system isolated instances of quality co
22、ntrol points not monitored no records available 1.2(*) Records indicate product shipped conforms to current specification(s), Quality Assurance Program(s) (QAP) and appropriate regulatory guidelines. (Records) All points (25 points): Review all product and process records to determine if the product
23、 consistently conforms to the current specification, Quality Assurance Program and all regulatory guidelines. This includes all records related to product processes, weighing, packing and labeling. (Regulatory agency guidelines shall be adhered to and proper documentation required by these groups sh
24、all be maintained. Separate regulatory files may not be necessary if records are located elsewhere.) If a QAP control point is not tested (refer to 1.1), the supplier cannot verify product meets specification. This constitutes no points for this question. Minor non-conformance (15 points): One of th
25、e following will constitute a minor non-conformance: QC records contain isolated errors which did not result in the release of non-conforming product isolated instances of incomplete or missing records Major non-conformance (6 points): One of the following will constitute a major non-conformance: QC
26、 records contain numerous errors which did NOT result in the release of non-conforming product numerous instances of incomplete or missing records records are incomplete for regulatory agency compliance requirements January 2003 Quality Systems Audit Page 4 No points: No points will be awarded if an
27、y one of the following is encountered: QC records indicate systematic failure due to the number of incomplete or missing records any instance of records indicating the release of non-conforming product; may include calculation errors, oversights, omissions, etc. product which did not meet regulatory
28、 guidelines was released a combination of two or more major noncompliance points no records 1.3(*) The product and packing conform to specification / Quality Assurance Program through observation. Any non-conformance is handled appropriately. (Observation) All points (20 points): Observe and evaluat
29、e product testing conducted by plant personnel for adherence to Quality Assurance Program requirements and methods. Product from current production or storage shall be evaluated for compliance to specification, including packing and labeling requirements. If the product, packing and/or labeling does
30、 not meet all specification requirements and applicable Quality Program, the non-conformance must be handled appropriately by placing the product on hold. Special attention shall be paid to tare weights. If the supplier is not producing Yum! Brands product on the day of the assessment and there is n
31、o product available in storage, this point should be scored n/a. Minor non-conformance (15 points): A single observation of an isolated instance of incorrectly packed, labeled or weighed product without corrective action. Major non-conformance: No major non-conformance category for this element. No
32、points: No points will be awarded if any one of the following is encountered: the product does not meet all specification requirements the non-conformance was not handled immediately and the product was not placed on hold more than one observation in one area of incorrectly packaged, labeled and/or
33、weighed without corrective action process observation shows a practice which negatively impacts product quality or food safety product is found to have a potential health risk and the appropriate action is not taken 1.4 Testing procedures are established for all product attributes in the specificati
34、on(s). (Procedures - Records) All points (5 points): Formal methods and/or procedures (Standard Operating Procedures/ Work Instructions) for all physical, chemical and microbiological tests are documented and utilized for raw materials and finished product testing. Only approved (AOAC, BAM, Yum! Bra
35、nds, etc.) procedures are used. Any deviation in test protocol from those outlined in the specification or quality assurance program requires a Letter of Variance from the appropriate Yum! Brands QA contact. All tests required in the specification and Quality Assurance Program are included in this r
36、equirement. January 2003 Quality Systems Audit Page 5 Minor non-conformance (3 points): One of the following will constitute a minor non-conformance: single instance of missing procedure single/isolated instance(s) of incomplete procedures Major non-conformance (1 point): One of the following will c
37、onstitute a major non-conformance: isolated instances of missing procedures numerous instances of incomplete procedures single/isolated instance(s) of unapproved methods/procedures No points: No points will be awarded if any one of the following is encountered: numerous instances of missing procedur
38、es numerous instances of unapproved methods/procedures 1.5 Individuals are formally trained to conduct assigned testing and QA evaluations. Skills shall be assessed. (Procedures - Records - Observation) All points (10 points): Review the procedures and records to determine if the individuals respons
39、ible for conducting tests and quality inspections are properly trained. This includes all individuals who are performing physical, chemical and/or microbiological analysis. Training will be verified through a record review and observation of individuals performing tests. The training program shall:
40、define the skill requirements, and training method(s) evidence of employee training both initial and annual training updates. Examples are: check sheet copy of a successfully completed test, supervisors evaluation form. have exit criteria to assess the effectiveness of the training. Exit criteria in
41、cludes what steps or tasks must be learned, and a test or evaluation by a supervisor against a defined set of criteria contain a tracking program by individual to track training received and assess progress against training skills needed. If initial training is not evident due to employees long tenu
42、re with the company, a document that the employee has been grandfathered into the program is acceptable. This only applies to the period prior to beginning Yum! Brands Quality Systems Assessments. Minor non-conformance (7 points): One of the following will constitute a minor non-conformance: trainin
43、g records contain isolated omissions (missed dates or missed sessions) one element of the training program is missing Major non-conformance (3 points): One of the following will constitute a major non-conformance: training and/or tracking records contain numerous omissions training records not avail
44、able for all employees conducting product testing two elements of the training program is missing. January 2003 Quality Systems Audit Page 6 No points: No points will be awarded if any one of the following is encountered: a documented training program for personnel does not exist more than two eleme
45、nts of the training program are missing it is observed that personnel do not know how to properly conduct testing or calculate the results. Corrective actions not implemented where observations show training to be inadequate. 1.6 A process is established to manage the accuracy and precision of all K
46、PI testing. (Procedures - Records) All points (10 points): The supplier shall demonstrate a process is established to manage the precision and accuracy of all KPI testing. Statistical comparison should be used where possible. For the attributes that are not compared statistically, the program shall
47、describe the calibration methods for the attribute. The comparative standard is the methodology or standard that is used to measure the results against. The procedure shall include: methods of calibration of all testing associated with all KPIs identified in the product specification / KPI report ca
48、libration of methods for all personnel responsible for testing calibration sessions for all personnel at least twice annually identification of the comparative standard for each test acceptance criteria or acceptable measurement error tolerance action plan for all of out of tolerance results Records
49、 shall include: results of calibration sessions corrective actions for the results that are not within tolerance Minor non-conformance (7 points): One of the following will constitute a minor non-conformance: records or procedures contain single/isolated omission(s) records contain single/isolated d
50、eviation(s) from the schedule comparative standard not identified for each attribute Major non-conformance (3 points): One of the following will constitute a major non-conformance: records or procedures contain numerous omissions numerous deviations from the testing schedule are noted reference stan
