Small company of approx 28 Employees - ISO-9001:2008 Guidelines

[PFMEA]

Hello Everyone,

I just took a QA Manager's position within a small company of approx 28 Employees. The company assembles electronics and does some sorting of Auto parts for a tier two company.
In looking at their Quality Manual and then the Operating procedures I found something very odd to me.
They only have 3 OP's and then the rest goes into Flow Diagrams as a Process Map.
I have never seen anything like it before, but they have passed many other audits beforehand with these documents.

The other question I have is contained within the OP's has the definitions spelled out with the person responsible. The old QM's name is falls under one of the definitions as a Supporting or Primary Role.
Since that person is no longer with the company and I change the role to my name, does that require a revision change to the OP document?

Thanks in advance..

D

 

[Ron Rompen]

Congratulations and good luck on the new position. I was in exactly the same boat a few years ago, and had the same type of experiences.

I (with the advise/assistance of our registrar) changed ALL our procedures into flow charts - made it much easier to follow. I also removed any reference to specific people, and changed it to title.

And to answer your question, yes, it IS a revision to the document, however I would urge you to change the 'standard' to reference position titles rather than names.

 

[normzone]

Good luck to you, and if you have an environment that is simple enough to sum up in flow charts then I envy you.

My problems include a top management person who once received positive feedback from an auditor regarding simple flow charts, and now believes that all process documentation should be done that way. This person comes from a soft graded environment and has some interesting expectations.

 

[PFMEA]

Thanks very much for the information guys.

I have to spend some time and go over the Quality Manual and the Procedures.
Sad part is that there has not been any internal audits performed since last year which the records are hand written on lined paper.
Regardless, the 6 month surveillance audit is on the 31OCT which only gives me a couple of weeks to audit the system and hopefully find no NC's.
The next stage will be transfer to the 2015 version which I don't have any idea what is involved.
I hoping to get through this audit and then focus on the 2015 standard for next year...

 

[Ajit Basrur]

Good Luck, PFMEA

 

[PFMEA]

Another quick question regarding the audit plan.. Looks like I am the only person who can perform these audits. Is that not a conflict of interest?. Should there not be a cross functional team auditing the process?. There is only 3 of us on the management team.

Thanks in advance...

 

[Ron Rompen]

You as the 'sole auditor' will only be in conflict when you are auditing those items which you are responsible for (such as internal auditing).

You definitely need to have at least one other person trained as an internal auditor. I know its a hard sell to the management group, but sometimes they just have to bite the bullet.

 

[MichelleMcR]

PFMEA - I am in nearly the same boat as you in both cases.

We have organized our QOPs with a front page that explains anything not covered in the process map or chart (whichever is more appropriate) developed to illuminate the process. It works for us.

I am the lead auditor for all audits excepting the audit which audits auditing (three times fast for that one...). I may assist on the other parts of that audit, but I have a coworker that I've trained as an internal auditor that performs an audit of my processes by herself and must finalize the audit without my interference. It isn't terribly difficult to train someone if you have the training to do so yourself.

Hope this helps!