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.	
7.2.2	Sales/ Contract review		x	Non-conformity: The process to ensure customer quotations are generated, reviewed and issued to the customer was found to be ineffective in practice.

Requirement: The Contract review process is outlined in Windsor Machine Products procedure PR-SE-001 and the practice is to track status of all quotes through a quote number and log to ensure timely issue to customer.

Evidence: There are RFQ’s received where there is no evidence to show that the quotations were issued or what is the current status. There appears to be a process for certain requests and it is unclear how others are handled. 
Quotes # 3945 for Flexible and quote # 3963 for Tenneco were examples were no information could be found.
	Windsor Machine tracks all RFQ’s received by assigning a tracking number to each incoming RFQ.  The sales manager reviews all outgoing responses.  The tracking log notes the status of each RFQ.
The RFQ’s are then filed in alphabetical order by customer and part number and kept for 2 years and then they are shredded.
Quotes #3495 and 3963 were in the file cabinet as per our procedures.	Windsor Machine will establish a procedure to review the RFQ log on a monthly basis and ensure that a response has been issued. 	A. Labutte
4/30/08			
7.4.1	Purchasing supplier evaluation		x	Non-conformity: The process to select and evaluate new suppliers is not effectively defined and implemented.

Requirement:	Clause 7.4.1 requires Windsor Machine to evaluate and select suppliers based on their ability to supply products in accordance with the organization’s requirements. Criteria for selection, evaluation, and re-evaluation shall be established. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained.
	
Evidence: 
(1) Procedure PR-PUR-001 states that a self survey (FOQA63) may be used.
There was no evidence available to show that this tool is being used.

(2) The procedure states that either the self survey or the Supplier’s Quality certificate is the evaluation process. The latter does not serve as the sole criteria for supplier approval. The current process is unclear and needs to be defined for all manufacturing sites and incorporated in to the supplier evaluation process.
(3) Also the feedback loop to Corporate Purchasing is unclear when site personnel do supplier visits. 
	Windsor Machine has established it own procedures to evaluate and select suppliers.  Evidence of both self-survey and certificates were provided.  Evaluations are defined by self-evaluation forms and supplier rating forms which were provided.
	None	S.Markoc
4/30/08			
										
7.5.1.2	Warehousing		X	Non-conformity: The process for Inspection as part of Packaging process is not documented for Chromed Head Rest Frames.

Requirement: Section 7.5.1.2 of TS16949 requires the organization to prepare documented work instructions for all employees having responsibilities for the operation of processes that impact product quality. 

Evidence: When auditing the Warehousing process it was observed that inspection being performed on “Temporary Head Rest Frame Chrome Quality Inspection” process was not documented for Frame Pt#L0043611AB. There were no acceptance criteria for Chrome Quality (Boundary Samples) as well as identification requirements (as per work instruction QSS503 and Packaging Control Plan) for any non-conforming product found.
	Windsor Machine Management team determined the root cause to this issue was no formal procedure addressing temporary processes and controls. The lack of instructions allowed the process to operate with minimum guidance and controls.	Windsor Machine will create a procedure to address temporary processes and controls (ECD 3/28/08), add control numbers to inspection forms (ECD 3/28/08), create specific process flow for H/R inspection area (ECD 3/28/08), create specific FMEA and Control Plan for H/R inspection area (ECD 4/11/08), Retrain all employees regarding these changes (ECD 4/16/08)	E. Warren 4/26/08			

B) Improvement Potential

Chapter
ISO/TS, ISO, KBA
VDA	
Process 	
Improvement Potential	
Corrective action 
of the company	
Respon-
sible / Date	
Corrective Action	
						Verific.	Effect.	
8.5.2	Corrective action	There may be a benefit to establish formalized action plans when negative trends occur in cost variance measurables. This could aid in establishing responsibilities, tracking countermeasures and show evidence of resolutions.
	-	-	-	-	
5.4.1	Quality objectives	Process measurables - To further monitor process measureables for the support activities (e.g. % On-time quotes) for accountability of process performance.
	-	-	-	-	
7.4.1	Supplier visits	Supplier visits - To establish and maintain records of all supplier visits and provide feedback to Corporate Purchasing.
	Field Trip reports will be used at all plant levels. This field trip report identifies all key items of a visit to a one supplier	J.Mitri/ 4/24/2008			
4.2.3	Document control	It may be beneficial to provide training for on line procedural access for the design group. This would improve accessibility of current information and remove the manual steps of maintaining hard copy binders.
	A meeting has taken place with the I/T department to provide the required training for online access to WMG data base	M.Dresser  05/01/2008			
7.3.3.1	Design FMEA	DFMEA electronic storage - To centralize design FMEA document storage for better controls and accessibility for the design group could be improved.
	Design manager to develop online access with WMG website for ease of record retention.	M.Brockman
05/03/2008			
8.4	Man. Review	Analysis of Scrap data and related cost (ie. scrap product, labor, administration, etc.) could be enhanced. 
	Scrap data and related costs will be reviewed and appropriate actions to enhance will be taken.	J. Mitri 
05/01/2008
			
7.5.5.1	Warehousing	The storage of Prototype and Sample product in the Quarantine area could be improved. 	Quarantine area to be outlined by floor markings and with an overhead sign.	E.Warren
05/01/2008			

							

Feb 27, 2008		Pauline McCusker		Ana Chau		
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.