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_X4 Supplier Onsite Audit Form FQA183

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FQA - 183 Supplier On Site Audit Form Corrective Action Plan Audit Date: Assessor: Discrepancy/Failure Correction/Action Plan Corrective/Action Plan Closed Date Item Number Target Date for Completion Responsibilit y
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Page 1: _X4 Supplier Onsite Audit Form FQA183

FQA - 183Supplier On Site Audit Form

Corrective Action Plan

Audit Date: Assessor:

Discrepancy/Failure Correction/Action Plan Corrective/Action Plan Target Date for Completion Closed Date ResponsibilityItem Number

Page 2: _X4 Supplier Onsite Audit Form FQA183

FQA - 183Supplier On Site Audit Form

Page 3: _X4 Supplier Onsite Audit Form FQA183

FQA - 183Supplier On Site Audit Form

Page 4: _X4 Supplier Onsite Audit Form FQA183

FQA-183Supplier On Site Audit Form

Released OC-01-07

SUPPLIER ONSITE AUDIT FORM

General Organization and Management Structure

No. ITEM EVIDENCE/ DOCUMENTATION REQUIRED OBSERVATIONS/NOTES Score Risk CORRECTIVE ACTION

1 High

2 High

3 High

4 High

5 High

6 High

Advanced Product Planning

No. ITEM EVIDENCE/ DOCUMENTATION REQUIRED OBSERVATIONS/NOTES Score Risk CORRECTIVE ACTION

7 High

8 High

SUPPLIER ASSESSMENT FORM

"0" = No Documented System and No Compliance; "1" = No Documented System but Compliance; "2" = Documented System and Partial Compliance; "3" = Documented System and Full Compliance

Is the Management structure and Resource allocation sufficient to support all necessary disciplines

Workplace Health and Safety practices are in place and are consistently adhered to

Does Management regularly communicate key operational and performance information to all employees

Management defines quality and performance objectives that promote Continuous Improvement

Responsibilities and authority are defined and evidence supports effective employee training

Management has sufficient resources to effectively manage Customer Requirements

Process to ensure detailed Contract Review, including Design and Capability review

Product Realization Process provides clear linkages between Product and Process Design and Control Methods

"0" = No Documented System and No Compliance; "1" = No Documented System but Compliance; "2" = Documented System and Partial Compliance; "3" = Documented System and Full Compliance

- Organization Chart with key positions filled- Resources appear adequate to fulfill all tasks- Established plan for succession

- Key personnel have required knowledge to perform job requirements- Sufficient language skills to support the Customer- Provision for 24 hour Customer support

- Plant is clean, orderly and well lit- 5S disciplines are in place- Appropriate machine guarding and safeties are evident- No signs of visible pollution or spills

- Posted information is appropriate and current (including Customer Ratings)- Evidence of communication sessions- Employee Suggestion Program

- Goals defined in the Business Plan- Goals reflect continuous improvement- Minutes of Management Review Meetings- Evidence of Cost of Quality Analysis & Tracking

- Job descriptions for all levels of the organization- Training Records (Including Contract)- Employee training defined & implemented- Cross-Training Matrix

- Presence of DFMEA, PFMEA & Control Plans- Linkage between PFMEA, Control Plan and Inspection/Control methods- 8D methodology links back to PFMEA and Controls

- Records of Design/Drawing Review- Records of Multi-Function Team Reviews- Understanding of Significant/Critical characteristic requirements

- Presence of critical inspection equipment (e.g. CMM, Material Tester etc.)- Availability to 3rd Party Certified Test Facilities- Inspection/Test records to validate testing - Responses to out of specification conditions

Page 5: _X4 Supplier Onsite Audit Form FQA183

FQA-183Supplier On Site Audit Form

Released OC-01-07

9 High

10 High

11 High

12 High

13 High

14 - High

15 High

16 High

Product Realization, Measurement, Analysis & Improvement

No. ITEM EVIDENCE/ DOCUMENTATION REQUIRED OBSERVATIONS/NOTES Score Risk CORRECTIVE ACTION

17 High

SUPPLIER ASSESSMENT FORM

18 High

Organization is equipped to support necessary verification, validation and monitoring of characteristics

Detailed process for managing Advance Quality activity and sufficient resources to manage activity

Process for Senior Review or Program Review of all new Programs

Capability to communicate Product design and Engineering Data with the Customer

A system in place to define approved packaging and for storage and preservation of product

Organization conducts equipment validation and performs run at rate in preparation for production

Process for New Product Launch and Containment activities

Sub-Contractor/Supplier product is controlled to ensure compliance

System to ensure conformance of purchased product

"0" = No Documented System and No Compliance; "1" = No Documented System but Compliance; "2" = Documented System and Partial Compliance; "3" = Documented System and Full Compliance

Adequate and effective Supplier Management Process

- Presence of critical inspection equipment (e.g. CMM, Material Tester etc.)- Availability to 3rd Party Certified Test Facilities- Inspection/Test records to validate testing - Responses to out of specification conditions

- Engineering software (e.g. CATIA, IGIS etc.)- CAE, Moldflow, Stress Analysis etc.

- APQP Documentation meets AIAG standard- Review submitted PPAP packages for accuracy and completeness- Organization Chart showing resources

- Run-at-Rate or OEE Documents

- Records of Early Product Containment- Review Pre-Launch Control Plans

- Tier 2/3 Supplier PPAP- Records of Advance Quality Planning with Tier 2/3 Suppliers- Records of regular Supplier Audits and development

- PPAP records for purchased products- In-coming Inspection Records/COC- Approved Supplier List- Reaction to non-conformance- Third-Party validation of Material Certifications

- Supplier Performance records- Records of Supplier response to non- conformance- Supplier Development of poor suppliers- Process to ensure use of Customer approved suppliers, when appropriate

-

- Evidence of Job Instructions posted on line- Records of Employee training- Job Instructions match controls as defined in Process Control Plans- Re-Work Instructions

- Approved packaging plans- Warehouse is clean & orderly- Packaging ensures protection of product

- Program Review Process Flow- Records of Program Review Meetings

Page 6: _X4 Supplier Onsite Audit Form FQA183

FQA-183Supplier On Site Audit Form

Released OC-01-07

19 High

20 High

21 High

22 High

23 High

24 High

25 High

26 High

27 Effective Problem Resolution process High

SUPPLIER ASSESSMENT FORM

Material, Facilities, Logistics & Tooling

No. ITEM EVIDENCE/ DOCUMENTATION REQUIRED OBSERVATIONS/NOTES Score Risk CORRECTIVE ACTION

Work Instructions for all employees affecting product quality, including for repair and re-work operations

Controls in place to verify process start up and job change-over

Effective Machine Preventive Maintenance System

System to identify, qualify and control Measuring and Test Equipment

Operators are trained and qualified for any required measurement and tests, including use of appropriate statistical techniques

Process to control and react to changes impacting upon Product Realization

Mistake-proofing and error-proofing used to control critical characteristics and ensure product integrity

Process & Systems Audits to ensure System Compliance and Improvement

"0" = No Documented System and No Compliance; "1" = No Documented System but Compliance; "2" = Documented System and Partial Compliance; "3" = Documented System and Full Compliance

- Supplier Performance records- Records of Supplier response to non- conformance- Supplier Development of poor suppliers- Process to ensure use of Customer approved suppliers, when appropriate

- Evidence of Job Instructions posted on line- Records of Employee training- Job Instructions match controls as defined in Process Control Plans- Re-Work Instructions

- "First-off" Inspection Records- Records of Job Start-up validation, authorized by appropriately designated signature

- Preventive Maintenance Schedule & Records, including downtime analysis- Database for spare parts- Visual condition of equipment- lack of leaks, grease etc.

- MSA Records- Inspection and Gauging identification- Calibration stickers and records

- Operator Gauge Instructions- Training Records- Capability charts are current and properly completed

- Engineering Change Records- Inspection Instructions are changed to reflect latest level- PPAP documents reflect latest level- Manufacturing Documents at latest level

- Error-proofing on line- Poka Yoke- Lock boxes for defects- Record of daily verification of error proof

- EDI Capability- Scheduling Notices- Customer Service documents- Delivery Performance monitored

- Review current 8Ds for completion- Evidence of CFT to resolve problems- Record of Customer Non-conformance reports & status. Evidence of Tracking Log.- Application of corrective action across all applicable and similar products

- Records of Audits- Audit Schedule based on process requirements (High Customer PPM, Failure Modes etc.)- Evidence of Lessons-Learned to drive improvement

Page 7: _X4 Supplier Onsite Audit Form FQA183

FQA-183Supplier On Site Audit Form

Released OC-01-07

28 High

29 Effective Material Identification and Control High

30 Material and Lot Traceability High

31 High

32 High

33 Plant Capacities High

High

System to ensure receipt of Customer schedules and requirements

Final Dock audits ensure integrity of packaging, Correct Part Numbers and Engineering Levels

System ensures preservation of Customer Tooling

- EDI Capability- Scheduling Notices- Customer Service documents- Delivery Performance monitored

- BOM matches labels on finished goods- No visible evidence of damage- FIFO

- Asset Tags and Tooling I.D.- Proper tool storage facilities- Tool Maintenance Records

- Supplier can provide summary of all new & pending Business and timing of critical dates- Current capacity studies and resource planning

- Material identified at all stages of operation (in identified containers)- Suspect material identified and segregated in a secure and segregated area- Proper storage of raw & finished materials- Evidence of FIFO- System to monitor inventory levels and drive reduction- Lack of visible bottlenecks or material constraints

- Lot Traceability Records- Receiving Records with Lot Numbers recorded- Shipping Records indicating Lot Numbers- In-process material with Lot Numbers- Shipped product can be traced back to received material- Check for use of Bar Code labeling

Page 8: _X4 Supplier Onsite Audit Form FQA183

FQA-183Supplier Onsite Audit Form

Supplier AssesmentGeneral Guidelines for Conducting Assessments

Supplier AssesmentGeneral Guidelines for Conducting Assessments

The Supplier Assessment is to be a process assessment and should accurately reflect the Supplier's actual manufacturing and quality processes, as evidenced on the manufacturing floor. The Assessment should validate that the day-to-day operations comply with the requirements detailed in the Assessment. It is insufficient for a Supplier to have documented procedures only.

Prior to the audit date, a copy of the Supplier's Quality Procedures should be obtained by electronic file or hard copy. The procedures should be reviewed prior to finalizing the audit date in order to ensure all assessment requirements have adequate procedures defined.The audit should be conducted by taking a current product that is manufactured and reviewing the process flow, as detailed. The Assessor should review the Advance Product Planning process used for the part in question, and then follow the manufacturing flow from receipt of raw material through manufacturing, storage and shipping. Additional disciplines including Problem Resolution, Testing, Re-Work etc. should be reviewed as well.

For each audit section, the required evidence/documentation is described on the Assessment Form. Key or critical requirements are highlighted in bold text. The Assessor should also use the "Observations & Notes" field to help clarify and explain their findings. A "High", "Medium" or "Low" Risk status will automatically be generated by the score assigned to each element. The Summary Score for each particular element will automatically be reflected on the Audit Cover Page.

All areas assessed as High Risk must have a defined Corrective Action Plan detailed, as well as dates defined for completion, prior to award of any business. Aside from the "High" risk elements, corrective action shall be at the discretion of the Assessor. The goal of Corrective Action is to eliminate all "High" risk elements in addition to attaining a score of 80% for each audit section. The "Corrective Action Plan" contained within the Assessment file, shall be used to track all corrective action activity.

Subsequent follow-up activity, and subsequent Assessments to validate implementation of Corrective Action, shall be the responsibility of the originating Magna Group and Supplier Quality/Development Engineer, and must be initiated with the award of business, at the latest. If the Assessing Group does not source business with the Supplier, development activity shall become the responsibility of the sourcing Group/Division, as defined by their Business Rules.

It is at the discretion of the particular Flex N Gate to base sourcing decisions on the final score attained. Each Groups' Business Rules shall define the selection criteria to be used. The aim of an Assessment is not simply the generation of a score. The ultimate aim is to identify and address areas of systemic failure driving undue risk to our Groups and Divisions, and therefore proper resolution and closure of "High" risk items, is critical.

Assessment results are for site-specific manufacturing facilities. If a supplier has two or more manufacturing locations, all locations require a separate Assessment.

The Supplier Assessment is to be a process assessment and should accurately reflect the Supplier's actual manufacturing and quality processes, as evidenced on the manufacturing floor. The Assessment should validate that the day-to-day operations comply with the requirements detailed in the Assessment. It is insufficient for a Supplier to have documented procedures only.

Prior to the audit date, a copy of the Supplier's Quality Procedures should be obtained by electronic file or hard copy. The procedures should be reviewed prior to finalizing the audit date in order to ensure all assessment requirements have adequate procedures defined.The audit should be conducted by taking a current product that is manufactured and reviewing the process flow, as detailed. The Assessor should review the Advance Product Planning process used for the part in question, and then follow the manufacturing flow from receipt of raw material through manufacturing, storage and shipping. Additional disciplines including Problem Resolution, Testing, Re-Work etc. should be reviewed as well.

For each audit section, the required evidence/documentation is described on the Assessment Form. Key or critical requirements are highlighted in bold text. The Assessor should also use the "Observations & Notes" field to help clarify and explain their findings. A "High", "Medium" or "Low" Risk status will automatically be generated by the score assigned to each element. The Summary Score for each particular element will automatically be reflected on the Audit Cover Page.

All areas assessed as High Risk must have a defined Corrective Action Plan detailed, as well as dates defined for completion, prior to award of any business. Aside from the "High" risk elements, corrective action shall be at the discretion of the Assessor. The goal of Corrective Action is to eliminate all "High" risk elements in addition to attaining a score of 80% for each audit section. The "Corrective Action Plan" contained within the Assessment file, shall be used to track all corrective action activity.

Subsequent follow-up activity, and subsequent Assessments to validate implementation of Corrective Action, shall be the responsibility of the originating Magna Group and Supplier Quality/Development Engineer, and must be initiated with the award of business, at the latest. If the Assessing Group does not source business with the Supplier, development activity shall become the responsibility of the sourcing Group/Division, as defined by their Business Rules.

It is at the discretion of the particular Flex N Gate to base sourcing decisions on the final score attained. Each Groups' Business Rules shall define the selection criteria to be used. The aim of an Assessment is not simply the generation of a score. The ultimate aim is to identify and address areas of systemic failure driving undue risk to our Groups and Divisions, and therefore proper resolution and closure of "High" risk items, is critical.

Assessment results are for site-specific manufacturing facilities. If a supplier has two or more manufacturing locations, all locations require a separate Assessment.

Page 9: _X4 Supplier Onsite Audit Form FQA183

FQA-183Supplier On Site Audit

SUPPLIER ASSESSMENT

ASSESSMENT REFERENCE#: N/A

SUPPLIER NAME: SUPPLIER CONTACT:

ADDRESS / CITY / STATE TELEPHONE #

FAX NUMBER: E-Mail Address

REASON FOR AUDIT: QUALITY ISSUES NEW BUSINESS

ANNUAL ASSESSMENT

N/A

CUSTOMERS (NON-AUTO): -None NA

ANNUAL SALES N/ACUSTOMERS (AUTOMOTIVE):

TS CERTIFICATION EXPIRY DATE ISO Other

Yes

YES- YES YES

X NO

X NO X NO NO

Has Certification ever been revoked? YES If Yes, State Reason: Y N

X NO Supplier has Liability Insurance?

PRODUCT FOCUS FOR ASSESSMENT

(Optional Comments)

Strengths of Organization:

Assessment Completed By:

Name: Group:

E-Mail:

Phone:

Approvals (if required by Group): Program ManagementQuality Purchasing

Name:Title:Signature:

DATE OF AUDIT:

FOLLOW-UP ASSESSMENT

Customer PPM

(Current)

CERTIFICATION DATE

ISO 14001 Certification

CERTIFICATION DATE

CERTIFICATION EXPIRY DATE

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Page 10: _X4 Supplier Onsite Audit Form FQA183

FQA-183Supplier On Site Audit Form

Revision Summary

Previous Level New Level Page # Element # Description

Page 11: _X4 Supplier Onsite Audit Form FQA183

FQA-183Supplier On Site Audit Form

Revision Summary

Description


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