Build a Quality Management System from scratch, or improve the old stuff? Which strategy should be chosen?

17th November 2020

It is not every day that an organization decides to build up a Quality Management System (QMS) from scratch.

When can we have such a dilemma if we should build something new from scratch?

Or if we should try to fix and update the old system somehow?

I guess there could be at least three primary reasons if an organization considers this question.

The old QMS does not effective at all

Some symptoms could be:

repeated major non-conformities in the last years, suspension of the certification,
customer escalations, permanent issues with customer satisfaction,
continuous struggling with the fulfillment of the customer requirements.

These are just symptoms and not causes. In such a case, a systematic root-cause analysis is necessary to understand the real reasons.

If it is evident that the QMS can not support the organization’s goals and fulfill customer requirements and reach customer satisfaction, intervention is necessary.

But you can not decide about the appropriate strategy without fully understanding the systematic causes behind the symptoms.

Greenfield investment in a new location

It often happens that a global supplier opens a new plant in a new location, maybe in a new country.

Should we take and copy (adapt) an existing QMS from another sister plant?

Can it work in a different environment by another organization, maybe with a different organization structure?

How about employee culture, discipline, the mentality is the same?

There are certain risks that a simple “copy & paste” approach will not work; adaption is necessary.

It is frequently said that “it does not make sense to reinvent the wheel,” but how much change is necessary to achieve the expected result? After so many changes, will we have the same robust system?

Which is the higher risk?

Inventing something which fits the new organization, to the working culture, start the building from scratch?

Or make changes/updates to the copied systems?

Indeed, there are not only black and white answers. It is also possible to take the best practices from the “copied QMS,” select those we expect will bring the desired results, and define the other necessary processes from scratch.

When can we expect a higher probability that the QMS will be accepted and followed by the organization?

Will they accept the QMS if they were copied from a different plant?

Not involving the organization in the definition of the processes can quickly result in an excellent system rarely followed by anyone.

A supplier steps into the automotive business, and it is a requirement from the customer

The target can be to reach a minimum an ISO9001 or an IATF16949 certification.

In this case, I suppose it is a more simple situation.

Copy and paste can not be an option because that will not work in a different organization, where there was already a particular way of workings method for years.

Updating the existing procedures seems to be the right choice.

Summary:

In particular situations, it can be a dilemma on which strategy should be used to build up the Quality Management System.

There are many pros and cons which need to be considered.

We should always keep in mind that the ultimate purpose of the QMS is to reach the organizations’ goals and fulfill the customer requirements and reach sustainable customer satisfaction through continuous improvement of the processes.

There are no simple answers. A systematic approach is needed to make the right decisions.

As always, think in system with Pro Automotive.

If you are interested in reading articles about automotive quality management topics, best practices, case studies, follow Pro Automotive.

by proautomotivequalityservices

IATF, MSA

Re-measure the product till you find it is OK!

10th November 2020

Why did you put that part there? – I asked the operator as an external VDA6.3 process auditor. We were at the final test station, and I just observed the tester measured one part as NOK, but the operator did not put it into the designated red box. She put the product away on a separate pallet.
They will be re-measured later on once more – answered the operator.
What happens if they pass the test on the 2nd measurement? – I asked again.
Then they are OK – answered the process engineer now.
What kind of settings are you using for the re-measurement?
The same parameters, just a dedicated program is chosen, but it equals the regular final test – the engineer further explained.

I turned to the operator again.

How do you know that such parts need to be separated? – I asked.
I was told – she replied.

Would you show this to me in the FlowChart?– I asked the engineer again.
Well, it is not described there.
Can I find this in the Control Plan?
Not at this moment. We have special instructions in place.
How many times can you re-measure the failed parts?
Only once more.
Why only once? How was it determined?
Well, we agreed on it as a team.
Could you please show me the relevant studies? How can you be sure that what you measure first as good they are really OK parts?

Finally, it turned out there were no relevant studies available.

The final tester was explicitly made for this new project. The customer approval was still missing, but the PPAP parts were already built.

Without considering the re-measurement in the Flowchart, in the PFMEA, no reference to the CP, which also means the customer does not know about it.

PPAP parts were built without having an MSA study in place. But due to the high fall-off rate, one re-measurement has been internally allowed.

How can we trust the tester’s judgment if it is not proved the system is applicable to the desired task?

How can I say that one re-measurement is allowed? Why not three? Or five.

How do I know which time the system judges correctly? When it shows an „OK” or „NOK” result?

If OK, I accept the judgment immediately, but if NOK, I doubt the result?

Most of us in the automotive quality field believe such a story can not happen in our plant. Only at small Tier-3-4… suppliers. Do not be too sure about this.

Anyway, it worth thinking about this story for a moment when you ask yourself, „What MSA is for?”.

Or when you make such a decision: „Let’s re-measure the failed parts once more, we might find some good parts!”

As always, think in system with Pro Automotive.

If you are interested in reading articles about automotive quality management topics, best practices, case studies, follow Pro Automotive.

by proautomotivequalityservices

IATF

How to prepare the organization for an audit?

3rd November 2020

One of the most important goals for the whole plant is to pass the next OEM audit successfully – announced the plant manager many times.

We found ourselves in a critical situation after a “not perfect” result from a customer audit. It happens sometimes. The evaluation we got was not acceptable for the customer, not for our organization. But we got a new chance. We had several months to fix the issues, implement the improvements.

To be clear – I did not drive this process; I was one active team member. But I learned a lot from this experience – I think it is worth sharing as best practice.

We listed the found non-conformities, defined the root-causes, and the necessary improvement actions.

But we did not stop there. We did not only focus on the technical stuff. We knew we had many things to do with the quality mindset of the whole organization.

As I described in my other post, part of the audit preparation is the colleagues’ preparation.

We needed a good plan, training the engineers, and preparing the shift leaders, technicians, and each operator or the production line.

Some quality guys alone can not reach such an ambitious goal. We had to engage all levels of the organization. How can it work? We had to involve them in the process. They had to understand what is their contribution to the Quality Management System.

By the way, it is an ISO9001 and IATF16949 requirement: 7.3 – 7.3.1. Awareness – supplemental:

“The organization shall maintain documented information that demonstrates that all employees are aware of their impact on product quality and the importance of their activities in achieving, maintaining, and improving quality, including customer requirements and the risks involved for the customer with non-conforming product.”

What was our plan? Training and training for everyone. They had to understand their contribution to part quality – and customer satisfaction.

But we knew training is not enough. Each person is different. Some of them are getting nervous if someone is asking what they are doing. They could make mistakes just because their hands were shaking.

We wanted to make sure about the quality awareness of each worker.

Therefore we created simple audit plans with essential but straightforward questionnaires. Mini audits were continuously performed.

Each workstation, each shift had to be audited. Here these mini audits were pieces of training at the same time.

Could not the operator answer successfully? No problem, he/she got the explanation right there. The goal of these audits was the excellent preparation of our staff. To increase and spread the quality mindset continuously.

Who were the auditors? The quality guys only?

No way! We intended to involve everyone—managers, process engineers, shift leaders, technicians – and finally, quality engineers.

This process did not happen in one day. It took many weeks, hundreds of mini audits, and training.

And the result? Our effort paid back! The following customer audit was a success.

But I believe we gained much more. We strengthen the quality mindset, the customer focus in the whole organization. We found a way how to increase the awareness of our people.

As always, think in system with Pro Automotive.

If you are interested in reading articles about automotive quality management topics, best practices, case studies, follow Pro Automotive.

by proautomotivequalityservices

IATF

How to (not) behave during a customer/certification audit?

27th October 2020

I do not precisely remember what the question from the auditor was.

I have no idea what the answer from my colleague was. I was with the other auditor; I explained something about the process. I could not follow what the other pair was talking about.

Then the auditor replied something, and my colleague just started sadly nodding with his head. Immediately he took his notebook and wrote what he just heard.

Then the auditor said once again something.

The same happened; my colleague made the notes. Then the auditor also started making notes.

I found myself in alert mode. Something was obviously not OK. I had to intervene immediately.

⁃ Is there everything alright? – I asked.

⁃ I am afraid, this and this I miss – the auditor explained what he was looking for.

⁃ Well, that we call a bit differently, but we have – I answered.

I asked my partner to show that.

He explained how that works because he knew that. But he was just blocked by the audit situation. He could not think clearly under pressure.

But the most dangerous was his body language.

He did not question what the auditor said. He accepted everything and just messaged: we were guilty.

Even that we had a good answer to the auditor question, we did a bit differently than the auditor’s first expectation. He was too nervous to recognize and gave up defending our way of working immediately.

Later, I gave him feedback, explained what I saw and sensed. We send messages without saying a word, just with our behavior and body language.

And we must defend our interest – if that is possible. At the production line, when and where the question was raised.

This situation was a lesson learned for me too. I should have known that. I did not prepare my colleagues properly. We are all different.

Part of the audit preparation is the preparation for the colleagues.

How to answer, what to say, what do not say.

A good practice to train our colleagues.

We can simulate an audit environment by conducting internal audits. The colleagues can get more comfortable with different questions.

There is an additional lesson I learned over the years. I repeat it every time to the guys as advice.

„Never brag” and „only answer to the question of the auditor”! „Only to the question, do not add anything else what additional things we are doing. If you answered the question, wait for the next question if there is any.”

This sounds too cautious or maybe odd, but I have seen issues so often because these single pieces of advice are not kept.

Do not forget that when you think about the necessary preparation for the audit, the participants should be prepared and trained as well.

As always, think in system with Pro Automotive.

If you are interested in reading articles about automotive quality management topics, best practices, case studies, follow Pro Automotive.

by proautomotivequalityservices

IATF

Know the standard from your heart! (?)

6th October 2020

Have you already read the standard from the first page till the end? – asked me the manager who was responsible for the Quality Management System.

Well…not all pages…- I admitted.

Then go away and come back when you did! -he replied. – I will not talk to you before.

Wow, what a rude guy -I thought, but I did not express my feelings.

I recently joined the company as a customer quality engineer and got a list of managers I need to talk as part of my onboarding process.

The” standard” he meant was the ISO/TS16949; now, it is replaced by IATF16949.

I thought he was impolite, and he could be more helpful to a new guy, but anyway, I followed his advice and read through the standard.

For many years I thought he was right – rude, but right. He was sick of explaining everything many times.

Ten years later, I found myself in the same position, responsible for the Quality Management System (QMS).

As it was a greenfield project, the task was also to build the QMS from scratch.

When we worked on the onboarding system, I remembered this unpleasant memory again.

Is it really a fair expectation that an engineer who talks to customers is familiar with the whole IATF 16949? Is it a requirement?

It definitely makes sense, and it is an advantage for sure.

But was this the right answer from the manager?

I doubt it.

His answer just proved that there were some rooms for the QMS improvement.

Why?

Roles and responsibilities – competence issue

What were the requirements for my position, were they appropriately defined? Was the ISO/TS16949 described as a must?

Lack of assessment of my competence against the requirement and appropriate action plan.

If the position required that knowledge, why was then not a lack of competence identified and relevant actions defined?

Who should be an expert on the standard? Should all engineers read the norm at home when they can not feel asleep? (They will probably fall asleep in 3 minutes.)

How will they know which part of it relevant’s their job? How can they apply what they learned in their daily work?

There is a better answer.

Engineers do not need to be an expert on the IATF16949. They do not need to know that from their heart.

It is our (who are responsible for the QMS) duty to make sure that the internal procedures are aligned with the standard requirements.

Our duty is that the onboarding system is robust enough and includes all internal procedures (documented processes) necessary to perform the specific job. This is what we should focus on.

Do not expect that everyone knows the standard from their heart.

Have robust QMS, which ensures that our daily work is aligned with the expectations from the norm.

As always, think in system with Pro Automotive.

If you are interested in reading articles about automotive quality management topics, best practices, case studies, follow Pro Automotive.

by proautomotivequalityservices

IATF

Before the FIRE starts – Control Plan with additional referenced parameter lists

1st September 2020

What is the revision date of this CP? – I asked the process engineer when I was performing a VDA 6.3 process audit at an automotive supplier.
Almost one year ago – the engineer replied and showed me the revision date of the document.
Was there any change in the process in the meantime? – I asked him again.
Nope – he replied immediately.
How about this machine parameter list? Which version is this? – I turned to him again.
Last update happened one week ago – the engineer said and proudly showed the revision list of the parameter list.

Finally it turns out that there were some changes in the process, but the CP has not been revised as “only” the referenced documents were updated. “Certainly” there was no change management activity, customer was not involved and by the way, the currently set parameters were not aligned with the defined parameters.

Typical solution at the automotive suppliers that there is a nice CP, several pages, contains mainly only product characteristics.

If someone takes a closer look, it is very difficult to find any process parameters in the document, but there are some reference documents linked to some machines, which are called as parameter lists.

These describes list of process parameters which need to be set to achieve the desired result: the product characteristics.

Is it the right thing to do?

From auditor point of view, I can not state that this is against the described requirements within the APQP/CP booklet or against any of the customer requirements as long as these referenced documents are part of the documentation system and protected and handled properly.

So why would this cause any issue?

Based on my experience, this is a method or the cause for the organizations to hide or make (without even recognizing) process parameter changes.

Oh, that is not always bad… Customer will not ask unpleasant questions, will not request unwanted documentations, samplings… who could wish more?

Not really:

It encourages line technicians, maintenance guys, process engineers to change process parameters without proper risk analysis whenever there is some problem in the process or with the products. Instead of proper root cause analysis, the process might be changed to the NOK parts.
- The CP revision history will not even include such changes as only referenced documents has been revised.
- Unauthorized process change could lead to escalation at the customer.
- Great risk for customer quality claim, impact on lifetime.

Why is it a problem of changing some process parameters when the significant characteristics of the parts are checked anyway 100%? We are sure that the parts fulfill its dimension specification.

I was faced several times with similar questions in the past.

The reason is that the process parameters have been verified and approved by the organization and by the customer within the PPAP activity.

It has been stated and proved that the described controls (process and product characteristics) are appropriate to produce parts which meet the customer requirements.

If any of these parameters are changed (out of the specified range), risk analysis regarding the impact of the change needs to be performed according to the customer requirements.

Within change management process, supplier needs to demonstrate that the modified process will also produce OK parts, customer notification or approval might be needed in prior the change is implemented.

I would encourage all quality managers and the quality engineers to review the CPs and verify if the process parameters are listed properly. It is better to list all process parameters directly in the CP.

As always, think in system with Pro Automotive.

If you are interested reading articles about automotive quality management topics, best practices, case studies, follow Pro Automotive.

by proautomotivequalityservices

IATF

ISO 9001:2015 Minőségirányítási rendszer bevezetése 1. rész: Hogyan válasszunk tanácsadót?

14th August 2020

LinkedIn post

by proautomotivequalityservices

Build a Quality Management System from scratch, or improve the old stuff? Which strategy should be chosen?

Re-measure the product till you find it is OK!

How to prepare the organization for an audit?

How to (not) behave during a customer/certification audit?

Know the standard from your heart! (?)

Before the FIRE starts – Control Plan with additional referenced parameter lists

ISO 9001:2015 Minőségirányítási rendszer bevezetése 1. rész: Hogyan válasszunk tanácsadót?

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