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SUPPLIER:

SUPPLIER AUDIT DATE:


AUDITOR:
AUDITEE:
SECTION 1 - QUALITY PLANNING

Is there a documented process (utilizing a team approach) for quality planning? The following elements should be included:

A. Design and specification review (Rate 0, 8, 14, 20)

B. Process flow charts (Rate 0, 8, 14, 20)

C. FMEAs (Rate 0, 8, 14, 20)


Are FMEAs correct, detailed enough to satisfy customer requirements, and numbered to match CP?
Do they reflect failure mode for all aspects of process including, Setup, Mfg, Packaging and Labeling?

D. Quality control process charts (control plan) (Rate 0, 8, 14, 20)


Does the Control Plan include all dimensional controls including RI, Setup, Operator checks, and QC checks?

E. Inspection Standards (Rate 0, 8, 14, 20)

Comments on Quality Planning:

Total for Section 1 - Quality Planning 0

SECTION 2 - DRAWING AND CHANGE CONTROL

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)

Comments on Drawing and Change Control:

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Total for Section 2 - Drawing and Change Control 0
SECTION 3 - GAGE CONTROL AND CALIBRATION

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

Comments on Gage Control and Calibration:

Total for Section 3 - Gage Control and Calibration 0

SECTION 4 - PRODUCT IDENTIFICATION AND TRACEABILITY

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

Comments on Product Identification and Traceability:

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Total for Section 4 - Product Identification and Traceability 1
SECTION 5 - PROCESS CONTROL

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?

A. Documented work instruction for each operation (Rate 0, 8, 14, 20)

B. Procedure for set-up verification (Rate 0, 8, 14, 20)

C. Identification and handling of non-conforming material (Rate 0, 8, 14, 20)

D. Application of statistical methods for critical/significant characteristics (Rate 0, 8, 14, 20)

E. Handling, storage, packaging (Rate 0, 8, 14, 20)

Comments on Process Control:

Total for Section 5 - Process Control 0

SECTION 6 - INSPECTION AND TESTING

Is there a documented system of inspection and testing? The following elements should be included:

A. Incoming parts and materials (Rate 0, 13, 23, 33)

B. In-process inspection and testing (Rate 0, 13, 23, 33)

C. Final inspection and testing (Rate 0, 13, 23, 33)

Comments on Inspection and Testing:

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Total for Section 6 - Inspection and Testing 1

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SECTION 7 - CONTROL OF NON-CONFORMING PRODUCTS AND MATERIALS

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)

E. Traceability of non-conforming or reworked products (Rate 0, 8, 14, 20)

Comments on Control of Non-conforming Products or Material:

Total for Section 7 - Control of Non-conforming Products or Material 0

SECTION 8 - CORRECTIVE ACTION

Is there a documented corrective action procedure defining methods and responsibility for developing effective
corrective actions? The following elements should be included:

A. Identification of root cause (Rate 0, 5, 10, 14)

B. Containment action taken (Rate 0, 5, 10, 14)

C. Long-term corrective action (Rate 0, 5, 10, 14)

D. Verification of effectiveness (Rate 0, 5, 10, 14)

E. Are corrective actions reviewed for use on similar product as preventative measure? (Rate 0, 5, 10, 14)

F. A method to update all supporting documents? (Rate 0, 5, 10, 14)


Including Work instructions, Control plans , FMEAs, etc.

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?

Comments on Corrective Actions:

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Total for Section 8 - Corrective Action 2

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SECTION 9 - QUALITY RECORDS

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:

A. Drawing and change control (Rate 0, 13, 23, 33)

B. Gage and test equipment calibration (Rate 0, 13, 23, 33)

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)

Comments on Quality Records:

Total for Section 9 - Quality Records 1

SECTION 10 - INTERNAL AUDITS / CONTINUOUS IMPROVEMENT

Suppliers must perform internal audits and maintain a matrix to track audit schedule, completion dates, and corrective actions
generated from audit findings.

A. Is there a matrix to track internal audits? (Rate 0, 13, 23, 33)

B. Are audits completed as scheduled? (Rate 0, 13, 23, 33)

C. Are corrective actions assigned and completed. (Rate 0, 13, 23, 33)

Comments on Internal Audits / Continuous Improvements:

Total for Section 10 - Internal Audits / Continuous Improvement 1

Page 7 of 11 SQA-FM-0001 / VERSION 10.0


SECTION 11- PREVENTATIVE MAINTENANCE

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)

E. Is tooling traceable to current part revision (Rate 0, 8, 14, 20)

Comments on Preventative Maintenance:

Total for Section 11 - Preventative Maintenance 0

SECTION 12- LABELING, AND BARCODE CAPABILITIES

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?

Comments on Labeling and Barcode Capabilities

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Total for Section 12 - Labeling and Barcode Capabilities 0

SECTION 13 - EMPLOYEE TRAINING AND CERTIFICATION

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.

A. Is there a documented procedure for training? (Rate 0, 8, 14, 20)

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)

Comments on New Employee Training and Certification

Total for Section 13 - Employee Training and Certification 0

GRAND TOTAL FOR COMPLETE AUDIT 0.461538


Corrective action is required if red block appears on rating. example
More than one finding requiring corrective action will have **. (example = 2 findings)
OPPORTUNITIES FOR IMPROVEMENT (OFI) are indicated by yellow block

POINTS RATING SCALE:

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".

100 - 90 = Excellent - All or most controls as required by Supplier Quality Manual.


89 - 80 = Good - Most controls as required by Supplier Quality Manual.
79 - 70 = Fair - Improvement must be made to meet Supplier Quality Manual requirements.
69 - 0 = Unacceptable.

INDIVIDUAL SECTION SCORING


Points per question: 14 20 25 33
RATING: 0 = Non-existent 0 = Non-existent 0 = Non-existent 0 = Non-existent
5 = Insufficient 8 = Insufficient 10 = Insufficient 13 = Insufficient

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10 = Acceptable* 14 = Acceptable* 18 = Acceptable* 23 = Acceptable*
14 = Good 20 = Good 25 = Good 33 = Good

* 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.

INTERNAL AND CUSTOMER PERFORMANCE RATINGS


§ PPM Customer
§ PPM Internal
§ Customer Complaints (Previous Year)
§ Customer Complaints (Current Year)
§ On-time Delivery (Customer)
§ On-time Delivery (Quotes)
§ On-time Delivery (Corrective Actions)
§ Quality Certifications
ISO 9001
TS 16949
ISO 14001

Upon completion of audit,load audit into Domino for management approval (SQA-WI-0001)

Is this supplier approved for sourcing? (CIRCLE)

YES / NO
MATERIALS MANAGER DATE
YES / NO
QUALITY MANAGER DATE
YES / NO
PURCHASING SUPERVISOR DATE
YES / NO
SUPPLIER QUALITY ENGINEER DATE

COMMENTS

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