An ISO/TS16949 Registration Maintenance Diary

[Icy Mountain]

We are now TS registered. As many have warned in this thread:
A TS16949 Implementation through Registration Diary
that is only the beginning. What appears below is a continuation of that saga. Hopefully this will assist others in what to do (and not to do) once the Initial or Registration Audit is closed and you’ve got that precious piece of paper.

First, I took careful notes during the initial audit of things that caused the auditor some concern. These items did not make it to the level of findings. However, they make a dandy starting point for Preventive Actions. Here’s my list:

• Clarity of the feedback path for information from customers (Sales Team Process Diagram or turtle addition)
• FIFO stock rotation, expiration dates on consumables (nothing important found out of date but we don’t have a documented rotation instruction)
• Warehouse shipping instructions (e.g. Wooden pallet regulations, Hazardous materials labels, Customer specific requirements (these were covered to the auditor’s satisfaction by an experienced logistics person that has left the company)
• Sales through shipment order checking (we have a good process but it could use a QMS Work Instruction.
• Green shipper vs. customer order checking procedure (ditto above)
• Post shipment checks detailed and documented (ditto above)
• Warehouse scales calibrated or known weights available (we dodged the bullet because these are not used to count parts, just to calculate shipping cost but they could end up being used to segregate shipments so that each box is below the customer’s weight requirements)
• Identify proper operating levels on gauges (e.g. air pressure)
• ESD wrist strap and heel strap checking consistency (we have a good process and instruction but form-filling is lacking)
• ESD/Quality Training for new hires (just keeping up!)
• Current revision/approved part number listed on Purchase Orders (adding a new requirement for every part)
• EXTENDING PPAP TO SUPPLIERS (more on this below)

-Icy Mt.

[Icy Mountain]

Next, keep up the maintenance that got you registered to begin with, Management Review and Internal Audit. Our Initial Audit was at the end of June and our Certificates say August 1, 2005. In Mid-September, we had another Management Review with three action items resulting:

• Our scrap and rework trend graphs look good but we had a couple of rework spikes based on our new practice of building and tracking Engineering prototypes, Beta units and PPAP product in the same manner as “Released” product. So we are going to separate pre-release rework from the overall scrap & rework graphs.
• Order SPC Manual Second Edition.
• Administrative Team to begin attacking the already low warranty costs and provide direction on any cost justified product changes to reduce these costs further.

Internal Audit in Late-September with 5 findings:

• 3 minor continual improvement findings related to clarification/typographical errors in procedures or quality records.
• 1 minor corrective action finding to clarify a “Team Leader” as a skill set in our training system.
• 1 minor continual improvement finding against our home rolled product development process.

This last one requires some actual work to make sure it is clear in both our “Quality Manual” and the actual work instruction where the elements of the standard are covered. While we had a lot of detail on the deliverables at each evaluation point, the actual activities required to produce those deliverables were not always evident. For example, TS requires a “layout inspection” during the validation phase. We say we do that in the procedures manual. We don’t list that as a specific deliverable in the detailed work instruction, unlike pFMEAs, dFMEAs, etc. We only list validation results against the specification.

Clarification is good for the soul, especially when the registrar’s auditor has made it clear that the surveillance audit will spend a lot of time on the results of our first product release to a TS subscriber under the new quality management system.
-Icy

[Icy Mountain]

After that, make sure you meet the important stuff:
7.3.6.3 Product Approval Process was a near thing during registration. Our only product with a Parts Submission Warrant was released to our subscribing customer one year before we started our Registration Project. Our biggest problem was “…process approval procedure shall also be applied to suppliers.”
We only escaped 7.4.1.2, Supplier Quality Management System Development, because we had a waiver from the customer to the “…suppliers…shall be third party registered to ISO9001:2000…” clause.

So, for our newest launch to our TS subscribing customer we have:

• Generated an “approved suppliers” list for all of the components that go into their product.
• Determined the QMS status and registration status of all of these suppliers.
• Generated a sub-list of suppliers of custom designed components. These are our number one priorities as there is no value to be gained from requiring PPAPs from Motorola on a diode in their catalog.

We will:

• Establish a relationship between our QA responsible folks and those at the suppliers.
• All of these “custom” suppliers WILL have a complete set of Quality Management System documentation, including an on-site evaluation if they are not 9k2k or QS/TS registered.
• Assist all of these folks to assure that we have a valid, PPAP documentation backed, Parts Submission Warrant for each of these custom components.
• Begin monitoring and development per our manual in order of priority.

That ought to be enough work to keep the Iceman busy until January!

[Icy Mountain]

It is November and I've achieved nothing listed in the first post. However, the stuff that is actually giving us improvement vs. satisfying auditors is going well:

• Scrap and rework are being reported in a more coherent fashion.
• All our AIAG manuals are up-to-date (including errata).
• Executive Management has delivered a detailed warranty statement to our service Department.
• 3 minor continual improvement findings related to clarification/typographical errors in procedures or quality records. (corrected)
• 1 minor corrective action finding to clarify a “Team Leader” as a skill set in our training system. (reviewed the training system with Team Leaders to see if we left anything else out)
• 1 minor continual improvement finding against our home rolled product development process. (Training, clarification and improvement of the product development process is resulting in a more efficient use of engineering resources).
• Establish a relationship between our QA responsible folks and those at the suppliers. (I am on a first name basis with the Inside Sales and QA contacts at 14 suppliers).
• All of these “custom” suppliers WILL have a complete set of Quality Management System documentation, including an on-site evaluation if they are not 9k2k or QS/TS registered. (10 of 14 covered by ISO9001 registration or better. On-site visits scheduled for the other 4).
• Assist all of these folks to assure that we have a valid, PPAP documentation backed, Parts Submission Warrant for each of these custom components. (Complete for 61 custom designed components).
• Begin monitoring and development per our manual in order of priority. (Two of the 4 that are not registered expressed GREAT interest in the offer of free assistance in getting their system registered to ISO9001!)

I must note that I was already on a first name basis with the QA Manager at the only supplier on this list that is registered to QS9000. They are our number one generator of Supplier Corrective Action Requests.

Here's what I am working on now:

• Multi-functional team to create a better understanding of our ECO process for everyone involved and streamline it.
• #1 feedback from suppliers is that we don't do a good job of clarifying the Drawing Number and Revision Level for custom parts. Since we often have rev X in production and are ordering protoypes at rev Y, there is sometimes confusion as to which parts are for "production".
• Training, training, training, lots of newhires.
• I have 2 days of APQP, PPAP and FMEA training to attend at AIAG this week!
• Three inch thick APQP/PPAP manual complete for our product launch this month!!!

And that's the way it is - Icy Mt.

[Icy Mountain]

Just completed a 1 day course for APQP and 1/2 day each for FMEA and PPAP at the AIAG mothership in Southfield, Michigan, USA. These were overview courses so there was not a lot of how-to, activity based stuff that would be necessary for a complete neophyte(newbie) to understand the material enough to implement it on their own. The instructor, Don Wood, has also done time as a trainer for Certification Body TS16949 Auditors. Therefore, he was chock full of information as to what the CB auditors have been trained to look for as Objective Evidence for APQP, FMEA, and PPAP. Worth its weight in gold for a battle-scarred holder of a TS cert starting down the barrel of his first surveillance audit.

[ralphsulser]

We just completed our first semi-annual TS16949 surveillance audit since registration in July.
Only 3 minors:
1-Lot number tracebility system had an incomplete document on 11/09/05
2-Dimensional results recorded only show 2 decimal places, spec. shows 3 places.
3-Work instructions not available for press lube testing and documenting.

Not too bad......TGIF

[Icy Mountain]

Completed my first fully compliant PPAP submission for a new product.

We have achieved PSW signoff for a 3000W 120VAC power source! This will be our second product approved by our TS requiring customer. Since this is now in the public domain I don't mind sharing.

Introducing the PowerPack3.-Icy

[Howard Atkins]

In Reply to Parent Post by Icy Mountain

Completed my first fully compliant PPAP submission for a new product.

We have achieved PSW signoff for a 3000W 120VAC power source! This will be our second product approved by our TS requiring customer. Since this is now in the public domain I don't mind sharing.

Introducing the PowerPack3.-Icy

Congratulations