Keeping an External Auditor on because he's "useless"...

[Sidney Vianna]

like a new member of management comes in and can show them their folly!

Or a new CB auditor does his/her job...

 

[AndyN]

Or a new CB auditor does his/her job...

Now, Sidney, should that be a 'New CB' or new (another) auditor from the same CB????

I'm thinking that one's more likely to be more effective than the other....

 

[Wes Bucey]

I think another "outside influence" besides a credible CB auditor might be a customer who gets burned by a SNAFU within the supply chain and tracks it down to THIS organization as the root cause of the SNAFU. That customer says, "Adios!" -

When THAT $$ impact hits the fan, there will be some upper and middle-level managers who get the idea that
"What's in it for me?"
means their job and bonus is on the precipice unless they get the QMS working the way it should.

A very large pharmaceutical company in my area got VERY lackadaisical about following GMP and blew off employee "suggestions" about shaping up UNTIL the FDA inspectors came in and shut them down cold.

Upper and middle-level managers whined and sniveled about how "unfair" the FDA was, but the very top managers saw the handwriting on the wall and the company spent millions on attorneys and outside consultants to put the operation back on track.

Today, ANYONE can audit the operation once closed by the FDA and see a smoothly functioning operation following GMP to the letter.

Funny thing - they've ALREADY recouped the cost of attorneys and consultants and the profits from that operation are rolling in because they eliminated the petty snag that irritates quality professionals the world over - "there isn't time or money to do it right in the first place, but there is ALWAYS time and money to fix the mistakes!"

 

[AndyN]

One would have anticipated that this CB auditor was thinking of the risk of his name being associated with that SNAFU! It appears that a very cozy situation has developed and, frankly, the CB's management should know, from it's own surveillances of auditors, that this is going on (I refuse to believe this guy hasn't got a whole cadre of similar clients).

However, I believe you are probably very correct, Wes. It will take a Ford/Firestone-like situation to bring attention to this travesty of registration.

 

[Sidney Vianna]

It will take a Ford/Firestone-like situation to bring attention to this travesty of registration.

Maybe not even that. How many thousands of façade certifications exist out there? How many organizations around the World pretend to have an ISO 9001-compliant system, and engages with an auditor who pretends to audit the organization?

The current economic meltdown should remind us all that, when the people entrusted with overseeing and/or regulating an activity fail to do their jobs, the consequences can be very dire.

When a CB auditor recommends an undeserving organization for registration, s/he is doing a tremendous disservice to all involved: him(her)self, his/her employer, the registrant, the stakeholders who rely on the certificate as an indication of the robustness of the certified system, and the part of the CB community that is trying to keep the integrity of the system. Each and every façade certificate contributes to the erosion of confidence in the system.

Reminds me of a fable about a goose that laid golden eggs....

 

[Sandra Gauvin]

Unfortunately, I also have experienced situations with a 'blind' auditor...which makes it very difficult to get management to do the right things....afterall, they were just told by the auditor that everything is great and you start getting labeled as a henny penny (the sky is falling) or as having a negative attitude. Continue to educate the work place to create a grass roots efforts until a better opportunity presents itself. Sometimes it's useful to learn what not to do as long as you don't adopt the bad practices and bring them to your new job.

Good Luck

 

[MsHeeler]

Unfortunately, I also have experienced situations with a 'blind' auditor...which makes it very difficult to get management to do the right things....afterall, they were just told by the auditor that everything is great and you start getting labeled as a henny penny (the sky is falling) or as having a negative attitude. Continue to educate the work place to create a grass roots efforts until a better opportunity presents itself. Sometimes it's useful to learn what not to do as long as you don't adopt the bad practices and bring them to your new job.

Good Luck

Wow! I just went through the same crap! Now I look like a Zelot without a clue. Oh well, I am done with that facility, I hope...

MsHeeler

 

[qualitymoron]

The best advice I was given by anyone was "get a job you love". I was in a similar situation working for someone who was essentially a bean counter and had no interest in quality - either of staff or product. Ultimately I left the company and now work in a team (including my MD) where (most) my input is valued, the changes are implemented I've suggested (or the case reasonably argued against it - I don't live in a fantasy world!) and our quality of product is fantastic. You cannot put a price on quality. However without the experience I've had working for a poorly lead company (and leadership is what it boils down to) I don't think I would work so hard in the role I'm in.
Regarding the poor auditor situation - Is the certification one you deal with UKAS registered? ie BSI, Lloyds, NQA etc? If they are you should get in touch with them directly and suggest that you're concerned that your current auditor is 'over familiar' with your processes and feel you could benefit from a 'fresh' pair of eyes.
Didn't you know that as well as quality we have to be diplomatic too?

 

[Bifften]

Regarding the poor auditor situation - Is the certification one you deal with UKAS registered? ie BSI, Lloyds, NQA etc? If they are you should get in touch with them directly and suggest that you're concerned that your current auditor is 'over familiar' with your processes and feel you could benefit from a 'fresh' pair of eyes.
Didn't you know that as well as quality we have to be diplomatic too?

Yes its one of the certification bodies mentioned. As it stands the auditor is happy to carry on, and my manager is happy to have him carry on.

I think dealing direct would be a certain way of me getting my P45 (thats the UK form for leaving employment...) Thats not a good option at this point in time sadly!

 

[Qwatcher2]

From the Registrar perspective, they will only know of the auditors lack of performance if you notify them or the auditor is being witnessed by the accreditation body. All registrars have a minimum of 1 witnessed audit each year by the accreditation body and it is a random selection. Most Registrars are very responsive. Each Registrar handles auditor assignments differently. Some rotate auditors but due to the lack of auditors, most assign the auditor and do not change them unless the auditor leaves, or the client or a customer of the client complains. Just be aware that if one of your customers audits you and finds the serious problems you have discussed and then complains to your registrar, the insuing investigation and reaudit will be much more stringent (they send in the big gun auditors with purpose) than if you requested a change of auditor or notified them of ithe issue with the auditor. Good luck!