President does not know what the Quality Policy means

[jmlacroix]

Hello,

I am working for a small medical device company and our president is really a research person (as opposed to a development person) that has a hard time in working in a regulated environment (i.e. ISO 13485). But he is the president and as such is representing Management. He is the one that sign the Quality Policy, written by the Management Representative (me).

As part of the Internal Audit program that I put in place this year (I started in January 2017 at the company. Previously Internal Audits were done by an external consultant), I have the following question that I ask various auditees: What does the Quality Policy represents to you? This is a question to grasp how the auditee sees him/herself in the whole concept of Quality. There is not really a good or wrong answer: most people understand their role in the overall quality.

In my Management Process audit, which covers mostly the section 5 of the standard, I ask the question to the president and the answer was: I do not know what to answer. I specified to the president that there was not a good or wrong answer, but still did not get any answer than: I do not know what to answer.

The fact that he cannot answer is a non-conformance as he is the one that signed the Quality Manual (i.e.: he signs the Quality Policy without understanding it). As a Corrective Action, I decided that a good ISO 13485 training would be beneficial to the president to better understand its role in ISO 13485. As the president think that QA is always asking things to create paperwork, I wanted the president to take an external ISO 13485 training by BSI: they are giving one in our city in February 2018.

But, our president refuses to get to such a training !

I do not really know what to do here to make him understand that its bad understanding of its role in the QMS prevents the company to perform better.

Does anybody has suggestion on things that I could do to help.

 

[Golfman25]

Yes. Stop asking trick questions. If your question is how the person fits into the QMS, then ask that. Referring to the quality policy, which is just a piece of paper on the wall somewhere, just confuses things.

Then walk him thru his role and his answer. Most likely it's a communications gap.

 

[Jane's]

In principle, agreed with the above, but not knowing what a QP is, is a bit of a red-flag (and the President's view of QA is not encouraging either). To lighten things us, maybe you could train him yourself, no need to send him for days long ISO 13485 training. Make a 5-15 minute long power point about the quality policy and Section 5 of the standard and that's your CA. PA is to make that presentation a part of the mandatory employee orientation/training for any new employees joining the company and for existing employees as well.

 

[AndyN]

Bon jour Jmlacroix!

I ask various auditees: What does the Quality Policy represents to you? Why ask this question? What are you hoping for as a response? I'm not sure it is a "trick question" (but I understand Golfman's comment). What are you hoping for an answer? As auditors, when we ask questions, we must have in our mind a response - what do you want to response to be?

 

[BradM]

Hello there!

My first, real life response to this is....
It's the President. Honestly, I may approach this different than I would other people. Yes he should know the policy; but people at that level are asked to sign a million things; especially in a regulated industry.

I would simply have a sit down with the President. Ask him/her is they still feel strongly about the Policy. If yes, then make sure the company knows about it.
Have a fun contest or something.
If no, then ask him/her if it needs to be modified to their liking.

 

[normzone]

Be careful where you go with that approach - I did that and was rewarded with a page of buzzword babble that I was unable to talk him out of, resulting in an external audit nonconformance and it having to be done all over, exactly as I'd suggested at first. Simple and basic, backed with real numbers.

Much of that "synergistic empowered agility " etc. may have a place in corporate philosophy but it cannot be readily measured and your customer does not care about it.

 

[AndyN]

Yes he should know the policy;

Agreed, Brad, but the OP didn't ask that straightforward question...(hence my post)

 

[BradM]

In looking over the original post... it does dawn on me there are a zillion unanswered questions for me.

To focus on a few (just in Brad's mind...):

Does the President not care about the quality shmality stuff; or is the quality policy questions/internal audit questions/ not being approached at a President level? Obviously one of those scenarios is easier to address than the other.

My opinion would be to leave it as is; and not worry about it. If the organization is audited and the President cannot address the Quality Policy; that's on them. I would just assure the rest of the organization understands it. I can pretty much bet there are much larger issues in the organization than the quality policy.

 

[Jane's]

that's on them.

As a mgmt. rep, the op definitely carries a good part of the responsibility. I am guessing that the audit NC already entered the system so some corrective action has to be construed. Finally, if found by the external auditor, who will be writing the CA? Not the president.

 

[BradM]

As a mgmt. rep, the op definitely carries a good part of the responsibility. I am guessing that the audit NC already entered the system so some corrective action has to be construed. Finally, if found by the external auditor, who will be writing the CA? Not the president.

This is the President in a small company. They can do not do whatever they wish.

I personally don't think a quality policy on the wall is worth picking a fight about.

For this internal audit, write it up, and train the President on the policy. If they don't like it, rewrite it. But just address and move on.

I've been in these scenarios before, and there will be plenty of quality fights down the path. To me, this is one of them. It worth it.

So train on it as correction; and have regular discussion with employees as CA.