A TS 16949 Implementation through Registration Project Diary - Automotive

[Icy Mountain]

Okey dokey,
Still waiting on approval of the Design & Development Procedure.

A large package of filling in the To Be Determined's, font corrections, and word alignments (e.g. use the TS term "Managment Representative" everywhere instead of sometimes using the 1994 "Executive Management Representative") is now complete and distributed.
Important stuff like:
Quality Management System
 Purpose
 Scope
 References
 Definitions
 General Requirements
 General Requirements - Supplemental
 Quality Policy
 Quality Objectives
 Quality Manual
 Engineering Specifications
 Control of Records
 Identification
 Collection and Indexing
 Filing and Storage
 Electronic Data
 Access
 Retention and Disposition
 Changed "Executive Management Representative" to "Management Representative"

Management Responsibility
 Correct Fonts
 HR Rep to Doc and Data Control Coordinator
 Job Description Matrix to TBO Training Register-TBO Skills List

Resource Management
 Correct Fonts
 HR Rep to Doc and Data Control Coordinator
 Fill in TBD for
 Product Design Skills
 Employee Motivation and Empowerment
 Plant, Facility and Equipment Planning
 Contingency Plans
 Personnel Safety to Achieve Product Quality

Measurement, Analysis and Improvement
 Fill in TBD for:
 Customer Satisfaction
 Internal Audit
 Manufacturing Process Audit
 Product Audit
 Internal Audit Plans
 Internal Auditor Qualifications
 Monitoring and Measuring of Manufacturing Processes
 Monitoring and Measuring of Product
 Add Work Instruction Internal Quality Audits
 Changed Auditing Standard from ISO10011 to 19011
 Changed "Executive Management Representative" to "Management Representative"

Most of these were already determined and/or written they just had not been reviewed and properly released.

I have written the Product Realization - Production and Service Provision procedure. Just a couple of minor changes (this procedure has been in place since long before we had a Quality Manual to put it in) to align with the rest of the manual and update some of the forms. Not distributed for review, yet. Let's get the D & D and updates released first, yo!

Implementation is coming along fine:
Quality Managment System will be complete by the end of the month with the release of the sections above and a comprehensive Control of Records Matrix. Document Control will pass an audit.
Management Responsibility will pass an audit as soon as I complete the last few action items from the September Management Review.
Resource Management will pass an audit.
Product Realization - see above, Purchasing and Control of Monitoring and Measuring Devices will pass an audit.
Measurement, Analysis and Improvement will pass an audit, with the exception of Internal Audit. IA will be performed in November, with followup completed by the December Management Review.

Boy, oh boy, are we getting close!
-Mr. Mountain

[Icy Mountain]

Had a meeting today with the Executive Management to review the Product Realization - Design & Development section of our Manual and the Level II work instruction for our Product Development Control Process, LINE BY LINE It took three hours, but I have an approved process for the manual and our company. YES!

For those of you who have been through this, you are probably saying to yourselves, "That lucky @#$^% should be glad it only took 3 hours".

I am. I am more thankful that we have a documented process for Design & Development.

[Icy Mountain]

Reviewed and approved the Design and Development procedure on 10/21. Having gone through a line by line with "Top Managment" made this rather easy. Now I need to get the Design Engineers on board.

The large list of changes 2 posts ago was approved on 11/5. Also approved were two new procedures for Planning of Product Realization and Control of Measuring and Monitoring Devices.

Completed D&D training with Engineering on 11/9 with mostly good results. I suspect that most companies that are in business and making a profit struggle with this section more than any other. The list of outputs and controls in TS is huge. Most companies I have assessed are compliant (or close to it) in all other areas. Here's the section where you are going to have to put more work into meeting the requirements, rather than just "say what you do". We went through our D&D review process today and it went smoother than ever!

Our last procedures, Production and Service Provision and the Control of Records Matrix, were reviewed and approved yesterday, 11/11.
OUR "PROCEDURES MANUAL" (quality manual) IS NOW COMPLETE!!!!!!

We have a comprehensive Internal Audit next week. That ought to be interesting and give us a lot of low spots to fill in. Follow up IA scheduled for 2/16/05 and 4/13/05 to clean up the details and show everyone we are serious.

Mgmt. Reviews scheduled for 12/9/04, 3/10/05, and 6/9/05.

Due to every reason except "We're not ready!" we have re-scheduled DNV for an April Pre-Assessment and June Registration. Mostly, because we want a TS Certificate on the first pass, not just a "Letter of Conformity". 1 complete year of system data and all that. Anyway, some of the pressure is off, I've got 6+ months to registration audit. I'm gonna start asking questions on the details here shortly.

DNV folks have been great throughout this process. So far, I would recommend their services to anyone. Great outfit, Sidney!

[Sidney Vianna]

In Reply to Parent Post by Icy Mountain

DNV folks have been great throughout this process. So far, I would recommend their services to anyone. Great outfit, Sidney!

Thanks. Even though I am not in charge of the District you fall under, I am glad you've had a positive experience dealing with us, so far! I tell you, TS is a tough Scheme to be involved with. Not only you have to deal with all the additional technical requirements (compared to ISO 9001), but from an administrative point of view, the registrars and auditors too, are barraged with a number of additional requirements.

[lday38]

While thew management review meetings are a quality record, does management review require a form that needs to be controlled?
It would be much simpler to state all input and output discussed is recorded
and maintained as a quality record. Any report can be evidence of management review , however, itshall be marked with the heading management review with date and attendees listed.

[db]

In Reply to Parent Post by lday38

While thew management review meetings are a quality record, does management review require a form that needs to be controlled?

No form, work instruction or procedure is required (other than 4.2.1 d) should that apply). However, if you use a form, it will need to be controlled.

[Icy Mountain]

Our first Comprehensive Internal Audit is now complete.

We generated 18 findings/observations/opportunities for improvement. At least 1/2 are related to having released 1/3 of the manual in the 2 weeks before the Internal Audit. On these findings, the procedure could not be verified because there were no records or when questioned, people could not demonstrate effective implementation. No kidding.

Only 3 are really serious and systemic but even these are easy to iron out with a little time and mileage on the procedures. For example, of the 12 employees asked, every single one could quote the Quality Policy verbatim. 80% could not really connect the QP to their daily activities when asked "What does that mean to you?" Mostly auditor shock, they do really well when I ask them. More training, I guess. Unfortunately, the write up against section 5.3 d) "QP.. is communciated and understood within the organization", makes is sound like no one knew the Quality Policy. I don't necessarily agree with this one. Every Registrar's Auditor I've ever seen went away happy if everyone could quote the QP.

Two were against training paperwork. We have quite a few adminstrative people who do work on the production floor when necessary, since almost all of them have been promoted from within, or designed and implemented the control plans to begin with; however, we neglected to make sure that those people were on the training lists (e.g., I wrote the training materials and trained most of our associates on proper soldering techniques but I don't appear on anyone's list as being trained in soldering). Paperwork! Second, in an Implementation Team SNAFU, we did not identify and approve, whether training was OJT or ClassRoom and how we validate it: oral or written test, or personal observation, or just plain attendance. This one we did to ourselves but it was under section 6.2.2 a) "...determine the necessary competence..."

Next UP:
Enter all of the findings into our Continual Improvement Process.
Get the Implementation Team together to go through the Observations, determine the Root Cause, assign responbility for action, implement Corrective Action, and close them out.
Management Review to go over the whole thing.

Only 90 working days left to Pre-Assessment.

[Icy Mountain]

All 18 Internal Audit Findings (6 Continual Improvements and 12 Corrective Measures) have been entered into our system that supports section 8.5, Improvement. Root Causes determined, actions planned and responsibilities assigned.

All of the updates to the Procedures Manual are complete, reviewed and approved (only 17 IAFs left! 12 of 18 should be closed before 2005).

I have a Customer Audit 12/14, followed by Management Review #2 on 12/15. Except for a few printouts that I'll do next week so they are current, I'm all ready for both. If it's not in place now, I certainly can't get it there in 2 days!