Académique Documents
Professionnel Documents
Culture Documents
Is there a documented process (utilizing a team approach) for quality planning? The following elements should be included:
Is there a documented system for drawing and change control? The following elements should be included:
A. Review and approval of new or revised drawings, manufacturing processes, and (Rate 0, 10, 18, 25)
specifications by authorized personnel prior to use. (Internal Change Request Procedure)
B. Positive system for updating documents affected by changes or revisions (Rate 0, 10, 18, 25)
C. Positive system for removal of obsolete drawings and specifications from point of use (Rate 0, 10, 18, 25)
D. A master list or equivalent identifying revision status (Rate 0, 10, 18, 25)
Is there a documented system for gage control and calibration? The following elements should be included:
A. A system for routine calibration and maintenance of all gages, measurement, and (Rate 0, 10, 18, 25)
test equipment
B. Are intervals frequent enough to assure continued accuracy (Rate 0, 10, 18, 25)
C. Production fixtures or jigs used for process control or to make acceptance decisions (Rate 0, 10, 18, 25)
should be documented in the same manner as any other gage
D. All gages, measurement devices, and test equipment should be uniquely identified (Rate 0, 10, 18, 25)
and indicate current calibration status
Is there a documented procedure for product identification and traceability? The following elements should be included:
A. A documented procedure should be in place for providing positive identification (Rate 0, 13, 23, 33)
of all material throughout all stages of the process.
B. A system for age control (FIFO, LIFO, etc.) (Rate 0, 13, 23, 33)
C. Are supplier parts (including components and raw materials) traceable to the (Rate 0, 13, 23, 33)
supplier's receiving and manufacturing records
Is there a documented system that defines the procedures, methods, and documentation requirements for control of the
manufacturing process? The following elements should be included?
Is there a documented system of inspection and testing? The following elements should be included:
Is there a documented system for control of non-conforming products and materials? The following elements should be included:
A. Positive identification of all non-conforming or suspect products or material (Rate 0, 8, 14, 20)
B. Segregation of all non-conforming or suspect products or material from the normal process flow (Rate 0, 8, 14, 20)
C. Defined responsibility for review and disposition of non-conforming or suspect product or material (Rate 0, 8, 14, 20)
D. Reworked products are re-inspected and/or tested for conformance to specification (Rate 0, 8, 14, 20)
Is there a documented corrective action procedure defining methods and responsibility for developing effective
corrective actions? The following elements should be included:
E. Are corrective actions reviewed for use on similar product as preventative measure? (Rate 0, 5, 10, 14)
G. Are corrective actions reviewed and approved by the necessary people to assure they (Rate 0, 5, 10, 14)
are feasible and the funding is available when applicable?
Suppliers must maintain a system for control and retention of quality system records for active life of the product plus one (1) year.
The following records should be included:
C. Quality performance records including inspection and test results (Rate 0, 13, 23, 33)
(One calendar year after the year in which they were created)
Suppliers must perform internal audits and maintain a matrix to track audit schedule, completion dates, and corrective actions
generated from audit findings.
C. Are corrective actions assigned and completed. (Rate 0, 13, 23, 33)
Suppliers must have a Preventative Maintenance program in place that includes documented regularly scheduled maintenance to
both equipment and tooling. Equipment schedules should be based on manufacturer recommendations. Tooling PM should be
based on historical data, or PMs scheduled on pre-production, or post production schedule.
A. Are machines and equipment on a PM schedule with records maintained for all service performed? (Rate 0, 8, 14, 20)
B. Are PM frequencies at minimum performed to equipment Manufacturers recommendations/specs? (Rate 0, 8, 14, 20)
C. Is all tooling maintained to a prescribed frequency? (By pieces produced or before and/or after use) (Rate 0, 8, 14, 20)
D. Are all tooling repairs and modifications logged or documented so it can be retrieved and reviewed? (Rate 0, 8, 14, 20)
Supplier should have a system sufficient to produce barcode labels to with minimal operator input, or an audit system that will verify
the information is correct with sign off for completion of verification by shipping personnel.
A. Is there a Work Instruction for labeling and label verification? (Rate 0, 8, 14, 20)
B. Does the WI include specific items to be verified, Part Number, PO Number, etc.? (Rate 0, 8, 14, 20)
C. Does the WI require sign off by two persons one applying label & another performing verification? (Rate 0, 8, 14, 20)
D. Is the proper printer and software available for generation of labels allowing ease of use for customer (Rate 0, 8, 14, 20)
specified information, and requirements.
E. Is the information the person(s) use to create the labels current and correct? How is the (Rate 0, 8, 14, 20)
revision maintained / updated?
Suppliers should have a documented system for traing employees, which designates the scope of the employees abilities.
This should include a ranking, or certification of their abilitys in a method that limits their activities to the level of training they
have achieved e.g. trainee, machine operator, operator trainer, setup operator, etc.. The system should ensure that a trainee
always be closely supervised by an operator certified to train. Product produced by any level of trainee should not be released to
further processing until it is validated by a certified operator, or 100% ceritifed by off line containment. A trainee should share
duties with an operator who is designated as approved to train, and not be overwelmed with all operator duties until fully certified.
B. Does it include operator levels of certification, including "certified to train" (new) operators? (Rate 0, 8, 14, 20)
C. Are training records available for most recent hires or position changes (if applicable)? (Rate 0, 8, 14, 20)
D. Was trainer certified or approved to train new operators? (Rate 0, 8, 14, 20)
E. Is there a method for containment, or approval of trainee produced product by certified operator before
release to next process, shipping, or stock? (Rate 0, 8, 14, 20)
Each section is worth 100 points. Total each section, then add the section totals together and divide by 13. This total should be
put in the "GRAND TOTAL FOR COMPLETE AUDIT".
* CAR may be requested for item deemed acceptable if system is acceptable, but discrepancies are found in documents.
Note: If N/A is entered as the score for any item, assign full point value for that item.
Upon completion of audit,load audit into Domino for management approval (SQA-WI-0001)
YES / NO
MATERIALS MANAGER DATE
YES / NO
QUALITY MANAGER DATE
YES / NO
PURCHASING SUPERVISOR DATE
YES / NO
SUPPLIER QUALITY ENGINEER DATE
COMMENTS