A) Non-Conformities
A root cause analysis and the implementation of corrective actions for all non-conformities must be completed and verified by the auditor latest 90 days for TS and VDA * questions <8 after the last audit day.
For non-conformities, which will be verified and checked for effective implementation (ISO and VDA) during the next audit, corrective actions must be submitted from the company to the auditor latest 14 days after the last audit day.

Chapter
ISO/TS, ISO, KBA
VDA	
Process 	Evaluation
Maj.  Min.	
Description of non-conformity
	
Root Cause Analysis 
of the company	
Corrective action 
of the company	Responsible / Date	
Corrective Action	
		NC1	nc2						Verific.	Effect.	
8.2.2	Internal audits  
(continued)		x	Nonconformity: The process to ensure customer specific requirements are included in the internal audits has not been fully implemented.
Requirement: 8.2.2.1 The organization shall audit its quality management system to verify compliance with TS and any additional quality management system requirements.
Evidence: 
From the sampled 2007 internal audits, there was no evidence to show that customer specific requirements have been reviewed for the audits performed in the last year.
	When performing internal audits the emphases was placed on the procedures and policies of the company and the customer specific requirements were overlooked.	Corporate memo issued informing internal auditors that when performing internal audits customer specific requirements must be taken into account. See attached memo.
A statement on the internal audit form FOQA66 has been includes notes on Customer Specific Requirements during the auditand reference to the CSR links.
It is the obligation of the Corporate Quality Manager to verify the effectiveness of Internal audits.  A special focus, this year, will be placed on making sure that all CSRs have been addressed.(As per J.Mitri Corporate Quality)
Corrective action plan reviewed and found satisfactory. Effectiveness of implemented actions will be verified at the next surveillance audit. P.McCusker July 15 08
	J Mitri 
6/6/08	PMC
07 08		
7.5.3	Heat  number traceability		x	The process to maintain traceability throughout the production process with regards to Steel heat numbers was found to be inconsistent.

Requirement: The organization shall identify the product by suitable means throughout product realization. Where traceability is a requirement, the organization shall control and record the unique identification of the product.
Pellus process is to take the heat number from the material tag as each coil is put on the machine.

Evidence: Headrest L0007789 production uses 1018 12 mill coil. Records at the line show the heat number to be A91023.There was no material tag to confirm what heat# was running. 
Receiving records show this to be an older shipment from March.
Likewise with part number 1146127, no tag was available to confirm records.
	Clear work instructions are not available to the operators that provide the operator with direction on how the traceability of the product is to be maintained.	Work instructions generated for the operators and have been made part of the instruction booklet at each manufacturing line. See attached work instruction.

Corrective action plan reviewed and found satisfactory. Effectiveness of implemented actions will be verified at the next surveillance audit
P.McCusker June 6/08	Todd VH
6/6/08	PMC
0608		
7.3.6.2	Product Approval Process			The process to ensure records of PPAP are controlled and generated was found to be ineffective.
Requirement: The organization shall conform to a product and process approval procedure recognized by the customer. Note: Product approval should be subsequent to the verification of the manufacturing process.
This product and manufacturing process approval procedure shall also be applied to suppliers.

Evidence: 
1.	There was no evidence to show that P/N L0029315 AA had been PPAP when change ECN 104962 had occurred.
2.	There were no records on hand to show the actions taken in response this ECN.

	WMG’s general practice for retention of the PPAP packages is that PPAP packages are maintained at the corporate office and only a copy of the signed PSW are retained at the plant level.	For all future PPAP’s Pellus will retain a copy of the entire package and the signed PSW.

Corporate has created a new requirement for all PPAPs to be propogated by the individual companies i.e. Pellus.   PPAPs will now be done for parts and components supplied intercompany.  When the production of a product or component is shifted from one location to another, the original production plant is required to submit all part blueprints, gauge layouts, PAPP documents, to the corporate office.  There, the PPAP coordinator or Quality Manager will ensure that the new production facility receives proper documentation of the part, and will require the new plant to go through the PPAP process.
As per J.Mitri, Corporate Quality.

Corrective action plan reviewed and found satisfactory. Effectiveness of implemented actions will be verified at the next surveillance audit

	Todd VH
6/6/08	PMC July 15/08		
B) Improvement Potential

Chapter
ISO/TS, ISO, KBA
VDA	
Process 	
Improvement Potential	
Corrective action 
of the company	
Respon-
sible / Date	
Corrective Action	
						Verific.	Effect.	
5.6.1.1	Cost of poor quality	Consideration should be given to expand on all the costs incurred by Pellus in incidences of poor quality. 	Cost of poor quality systems to be reviewed and potentially introduced at Pellus	Marc Charron / Todd Van Hal / Jerry Mitri 8/1/08			

July 15, 2008		
Pauline McCusker		
Todd Van Hal		
Date		Lead Auditor		Customer		

Information about the handling of corrective action      -      Criteria that must be fulfilled for auditors to accept corrective action	
1. Is immediate action required to prevent recurrence and/or delivery of nonconforming parts?	
2. Have the root causes underlying problem occurrence been identified? Has this been done using an adequate method?	
- In what instances has the system failed, allowing this nonconformity to occur?	
3. Is the problem system-related?	
- A specific incidence is not a system-related problem.	
4. Have measures to limit the problems involved in the specific incidences been taken?	
- If further external customers or projects may be concerned, have measures been taken to limit or correct the problems and protect these parties or projects?	
5. Does corrective action defined by the organization also take the following into account:	
- ...changes in the system, unspecified employees, procedures etc..?	
- ...and the identified underlying causes?	
6. Have the pertinent FMEAs (design and/or process) been reviewed on the basis of non-conformities?	
- Does evaluation of recurrence have to be revised?	
- Does evaluation of detection have to be revised?	
- Does the organization treat FMEAs as "living documents"? 	
7. Have the plans, work and test instructions of production control etc. been reviewed?	
- Does the organization treat this documentation as "living documents"?	
8. 100 % elimination of nonconformity is required:        --> 100% elimination means : 	
- Narrowing down the cause underlying the nonconformity to prevent customers from being exposed to risks	
- The root cause must be determined within the 90-day period and corrective action implemented and verified by the auditor by then. In cases involving long-term solutions (programming, new machinery, investments, etc.) proof of initiation may be furnished.	
- Documented evidence, e.g. action catalogue, instructions, records, to furnish proof that the non-conformity has been corrected, including the names of the persons responsible, or direct on-site verification within 90 days.	
- In a re-audit these measures must be followed up and verified and the nonconformity closed.