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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
FQA - 183Supplier On Site Audit Form
FQA - 183Supplier On Site Audit Form
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
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
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
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
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.
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
Quality System Audit X
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20
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60
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0 0 0 0 0
FQA-183Supplier On Site Audit Form
Revision Summary
Previous Level New Level Page # Element # Description
FQA-183Supplier On Site Audit Form
Revision Summary
Description