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.	
5.2	Customer Specific Requirements
(NC1)		x	Nonconformity: The process to ensure current customer specific requirements are maintained and changes implemented as needed is inconsistent in practise.
Requirement: Top management shall ensure that customer requirements are determined and fulfilled with the aim of enhancing customer satisfaction.

Evidence: Ford CSR current version is Feb 08, reference document on the company website was from March 06..

Likewise Eberspacher , Dana and Woodbridge Mexico CSR could not be confirmed.

Current process is for Corporate to maintain the CSR on the intranet and for the plant to ensure CSR implementation and training has not been maintained.
	Corporate is responsible for updating the web site accordingly in regards to Customer Specific Requirements. Cause of the sites not updated is the customer sites are not updated or they do not have there web sites finished properly this has been issues as well and they have been notified of this and are trying to update them accordingly.	The quality web site will have links to the IAOB web site and the customers website. 	John Wakulchik
8/29/2008	Yes		
5.6.1.1	Cost of poor quality
(NC2)		x	Nonconformity: The process to track cost of poor quality was not available for review.

Requirement: Clause 5.6.1.1 requires part of the management review shall be the monitoring of quality objectives, and the regular reporting and evaluation of the cost of poor quality.

Evidence: Rework cost is part of the business measurables, the process to collect and analyze the total cost of poor quality is unclear.
	During the management review on Feb / 2008 some information was not available to accurately determine the cost of poor quality.	Plant manager will assign adequate resources to assemble, analyze and report the cost of poor quality.	Paul Brancaccio8/29/2008	Yes		
7.3.6.3	PPAP
(NC3)		x	Nonconformity: The process to ensure Production Part Approval / PPAP is not implemented effectively.
Requirement: Clause 7.3.6.3 Product approval process requires Pioneer to 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: PSW dated March 20/08 for part L0079960AA to Woodbridge Mexico
lists Pellus site and not Tilbury Assembly on the warrant 
Also the referenced drawing L0079960AA dated Feb 06 does not link to the current Windsor drawing requirement for the chrome spec GS90010..This became the new BMW chrome requirement when Tilbury took this job over.
	The PSW forms are verified by PPAP coordinator Ana Chau signed and sent to the customer. The plant fills out the necessary information and PPAP coordinator fills in the IMDS information and assembles the rest of the PPAP information. This issue was brought up that the plant fills in all information so no mistakes are made when sending and filing forms. 	Tilbury has requested a change in print to verify the chrome specifications to the BMW chrome spec. 	John Wakulchik
8/29/2008	Yes		
	MSA - Gauge R&R

(NC3)			Nonconformity: The process to ensure MSA studies are performed within the defined frequencies has not been maintained.
Requirement: Statistical studies shall be conducted to analyse the variation present in the results of each type of measuring and test equipment system. This requirement shall apply to measurement systems referenced in the control plan. And as per the customer reference manuals on MSA. Other analytical methods and acceptance criteria may be used if approved by the customer.
Evidence: There were no records for final gauges used on parts 11-52-205-40-1-93 and 11-23-165-47-1-91.
Also data collected for L0079960AA could not be retrieved to show the results for 3 appraisers as per the MSA manual requirements.	Quality personnel  responsible for gauge control did not fully understand the MSA requirement. 	Looking into new ways of doing R&Rs and training new people on how to do and log information.. New forms are being made to track and maintain MSA and gauge R&Rs.	John Wakulchik
8/29/2008	Yes		
7.6	Calibration
(NC4)		x	Nonconformity: The process to ensure calibration of test equipment is maintained is not effective in practise.

Requirement: The organization shall establish processes to ensure that measuring equipment shall calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to NIST, where no such standards exist, the basis used for calibration shall be recorded
Evidence: 
(a)	A number of fixtures used on line are past due for calibration. Examples include Fixture for 11-23-165-47-191 due 08/06, Fixture for 250324 due 11/07 and 1123-165-47-191 due 01/08

(b)	Gauge blocks # 990686/990325 – no record of calibration on file.

(c)	Since Pro gauge is no longer in use, it is unclear how other pieces of equipment (other than fixtures) are tracked for calibration due dates e.g. shadow graph, callipers and scales. 
	a) Fixtures on the floor were out of calibration and were scheduled for calibration at Ellis Tool this was on the manual sheet in the quality office.

b) The gauge blocks had a calibration sticker on but the information was not written in the log book.

c)	The software Pro Gauge has been discontinued for some time and there is no available updates for this software and because of this is it causes crashes and lost information when the program is closed. There has been a replacement manual way of tracking the calibrations but it has been found not to be very effective due to time to imput information when needed. 

	a)	The fixtures are in the calibration schedule for re certification by Ellis Tool and is documented by log book as soon as the new software is up and running these will be logged in.
b)	Gauge blocks also will be logged in as well when the software is running. 
c)	The excel spread sheet has been in use in replacement of Pro Gauge and everything is manually logged in as soon as the new program is up and running this will be how we are tracking all equipment for calibration and is being updated as needed.
	John Wakulchik
8/29/2008	Yes		
Core Tools	FMEA
(NC5)		x	The process to maintain current information on the PFMEAs is not consistent.

Requirement: Core Tool FMEA manual requires update of PFMEA when new failure modes are identified or occurrences escalate.

Evidence: Process FMEA for Woodbridge part L0079960AA (311207) does not reflect current chrome issues. FMEA dated 11-Aug-07.
	The Job 311207-1 was moved from one location to Tilbury Assemblys plant. When the new documents were being done the date was not accurate and showed it to be incorrect. This was a oversite by the Quality dept. The PFMEA has not been updated because of the ongoing issues with the chroming it changes frequently and trying to get a handle on the issue is difficult to control.	ALL CARs that are issued will now have to check PFMEA for appropriate updates and inplement as necessary.	John Wakulchik
8/29/2008	Yes		
8.5.2	Corrective action – supplier responses

(NC6)		x	The process to obtain and close out corrective actions relating to supplier issues was found to be inconsistent.

Requirement: The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence. The process shall include: determining the causes of nonconformities and maintain records of the results of action taken.

Evidence: There were several incidences of supplier issues with regards to the chrome process by Rauscher for part 311207-1. Corrective action responses from the supplier were not available for review.

	There were many issues with the corrective actions in regards to the chroming issue that were open for reasons of a incapable process by the plater. These issues are hard to resolve because of the inconcistancy of the chroming processes. 	New procedure in receiving CARs from suppliers, an internal CAR will be issued so that there is a tracking process and will effect there scorecard.	John Wakulchik
8/29/2008	Yes		
8.2.2	Internal Audits
(NC7)		x	Nonconformity: The process of planning and completion of effective internal audits is not in place.
Requirement: 8.2.2.4 Internal audits shall cover all quality management related processes, activities and shifts, and shall be scheduled according to an annual plan.
When internal/external nonconformities or customer complaints occur, the audit frequency shall be appropriately increased.

Evidence:
1. No evidence to show that Corrective action, preventative maintenance, receiving & shipping and  Management review system audits have been audit in 2007 or in 2008 timeframe.

2. Past audit plans do not show how frequency of audits related to issue found through customer complaints or past findings or importance and status of processes.
3. Nor does the schedule clearly show what product and process audits need to be covered.
Evidence: For example no headrest product audits have been completed in the last year.

	The internal audit was pushed back until it was impossible to finish in a appropriate time frame. A few were done but the major of the internal audits were not finished in a timely manner. Scheduling was not properly scheduled for audits and auditors were very busy with there own plants. 	Jerry Mitri and Ana Chau will be involved in Auditing system at Plant level to assist in auditing. They will be used when the lack of manpower at plant level for auditing.	John Wakulchik
2008 / 2009	Yes		
8.2.2	Internal audits  
(continued)		x	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: 
3. There is no evidence to show that customer specific requirements have been reviewed during the internal audits.

	Since the web sites were not being updated the sites were not being used properly for viewing and checking for new requirments.	A plan has been sought out that corporate PPAP coordinator is updating the sites, when a site is found by a Quality Manager that has not been updated a email request to Ana Chau will be issued to have the site updated.	John Wakulchik
2008 / 2009	Yes		

B) Improvement Potential

Chapter
ISO/TS, ISO, KBA
VDA	
Process 	
Improvement Potential	
Corrective action 
of the company	
Respon-
sible / Date	
Corrective Action	
						Verific.	Effect.	
8.5.2.2	Mistake Proofing	It may benefit Tilbury Assembly to mark up the “red herring “ parts used on the new tube line as such. And consideration should be given to documenting when these mistake proofing checks are performed.	The new tube line ( red herring) parts were implemented and in place.	TBD			
8.5.2.3	Corrective action impact	There may be a benefit to include a section on the CAR to state corrective action impact was considered and list where this applied, if applicable.	Being looked into.	TBD			

May 6 2008		Pauline McCusker		John Wakulchik 
		
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.