Overwhelmed, next audit around the corner - Responding to Nonconformances Identified

[danzio]

and we have not satisfied the NCR's of the last audit and the best part is.....Our QA Manager quit on us last month! After being with the company 15 years he leaves, giving us one weeks notice.

Here is our situation.

We are a small machine shop with less than 40 employees. We have been registered since 1998. We are due for surveillance audit and re-certification next month.

I received a call from the registrar's exec. commitee chairperson stating that our NCR's were not responded to appropriately from the last audit.
Our QA manager was the only one involved in the audits, basically he would just brief us afterward at the management meetings. I don't even know how to respond to her new request regarding the NCR's. She said something about a 5y form. Which I now believe is "5 Why's" after doing some research (that's how I stumbled on this website/forum.)

We need some immediate help to stop the bleeding.

If we were to ignore this and just allow our current registrar to pull their certification, could I simply hire a consultant and start the process with another registrar, basically starting from scratch, but this time getting more involved at the start?

Any input greatly appreciated.

[BadgerMan]

I would ask the registrar for an extension of the due dates for the corrective action responses due to the management representative’s leaving the organization.

Then, generate a corrective action plan for each of the NCR’s, with input and buy-in from the management team, and submit them in advance of the upcoming audit. Then, the auditor can review the plans and monitor their implementation for effectiveness.

This would be much easier than going through recertification with a new registrar, IMO. Besides, a new registrar will still want to review the previous audit results and ensure any resulting corrective actions have been implemented and are effective.

[Gerry Quinn]

It sounds as though your organization didn't get involved in the quality system and left it all to the quality manager.

Why bother with registration and the installation of the quality system if top management doesn't realize that they have to be intimately involved? The system can't be worth much and it won't hurt you any to be without it.

So ask yourself, "What am I getting out of this system? Why bother keeping it?" If the answer is "We need the Registration document in order to do business." Then go find a paper mill, buy a cert. and save all of the headaches.

[danzio]

In Reply to Parent Post by Gerry Quinn

So ask yourself, "What am I getting out of this system? Why bother keeping it?" If the answer is "We need the Registration document in order to do business." Then go find a paper mill, buy a cert. and save all of the headaches.

Any ideas on where I would find one.

[BadgerMan]

Get your management involved in the generation of corrective action plans. That will be the best way to measure their commitment to the system.

[Wes Bucey]

Welcome to the Cove!

I'm sorry it has to be under such stressful circumstances.

I know this advice seems difficult to accept, but RELAX! This is important stuff, but not life and death. Most registrars will be more than willing to grant you a sufficient extension to get yourself up to speed. If not, contact me through a Private Message or email and I will help you negotiate with them.

By now, you've learned that there is a lot of nitty gritty stuff about formal registration to an international Standard like ISO9001:2000 which you trusted your former Quality Manager to insulate you from. I regret seeming to "pile on," but he erred in not keeping you involved from the beginning. There are important things you should look for in his replacement. Primary in that list of qualifications is a strong willingness and ability to act as a teacher and mentor to everyone in your organization to ensure EVERYONE is knowledgeable about the Quality Management System of your organization and the requirements of your customers.

As part of your research, you DO need to come to a decision about the importance of formal registration to a Standard. If this is customer-mandated, then you know you have to bite the bullet. If not a requirement of your current or projected customer base, then you should consider investing the fee for registrars into additional salary for a well-qualified Quality Manager, perhaps with the temporary assistance of a consultant who can act as your advocate rather than pay an arm's length auditor. The difference is simply that the consultant would help you work out viable solutions to your NCR's instead of expecting you to do it on your own.

A word of caution:
Some folks will look at you the same way a shark looks at a bleeding fish or other animal - FOOD! Others may be scornful that you allowed yourself to be caught in such a position. History doen't matter at this point. The important thing is how you handle yourself from here on. Do not allow yourself to be swindled by some sharpie who offers an instant fix. Do not waste time accepting punishment for past lapses in judgment. Be systematic in selecting help. Vow to stay personally involved in your Quality System. There is every chance this may turn out to be a blessing and you will emerge from this temporary situation a stronger and better organization than before.
The majority of the folks here at the Cove will be more than willing to help you. Don't let yourself be easily discouraged.

[Greg B]

Danzio, (Welcome to the Cove)

I agree with Wes and Badgerman. Ask for an extension. In my last job I took over the QA system from a guy that had burnt his office down and then decided never to turn up to work again. He burnt all the records and the PC. I had some half charred noites to work with and had to basically rewrite the entire system from a disk that had outdated software and nothing could read. It took me 3 weeks just to get the office in order and find someone that had software that would read the magic disk. We had an audit pending and outstanding NCRs. We survived.

Recently, at my company noone would listen or partcipate in quality and I took the drastic step of ensuring that our Registrar would NCR us. It worked and now our management team are falling over themselves trying to please the auditor. The auditor and I go way back and always new we would be able to recover from a few NCRs. When the review comes around in a few weeks not all of the NCRs will be complete but we can show that they are being acted upon and things such as audits and training are again underway. You must remember that a QA system is fluid. It is never stable so there are always things changing. It will NEVER be perfect on the day but you need to able to show your willingness and actions to ensure that in the end everything will be in line with the standard and your business practices.

What are the NCRs that you have? (In broad terms). We may be able to help you with strategies to fix them.

[RCBeyette]

Hi, Danzio.

You've received some great advice from Badgerman, Wes and Greg. Wes brought up an excellent point though in reminding you to relax. Yes...we know...easier said than done. While I doubt many of us have been exactly in your position, we can empathize...our experience has taught us to remember to breathe and, when in doubt, laugh.

Take a step back, look at the big picture and then start your game to address these NCRs.

Wise words were given to you to have your top management not just involved, but actively involved in developing the plans to address these NCRs. Not only does it demonstrate committment, but it certainly is nice when they understand what the heck is going on, right?

I'm a little perplexed at the auditor's mention of a 5-Why form. Was that in relation to an NCR or an Opportunity for Improvement. There is not direct 'shall' requiring the use of such a tool (although it can come in handy).

As Greg offerred, please feel free to share these NCRs with us (unless there are some confidentiality rules that you perceive). While we may not necessarily develop direct solutions, we may be able to provide you with some options to approach your management with.

And lastly, the game plan for your system overall. It is a shame that the Quality Manager's departure was the first and only indication of an improper balance of responsibities within the Management System.

It might be beneficial (and score brownie points with the auditor) if you and the management committee were to develop a sort of "designate" program (i.e., who can complete the tasks when the normally scheduled individual is not there) and/or proper distribution of tasks of responsibilities. For example, I am the 'administrator' of our document control program...however, each department is responsible for their own documents (development, control, training, etc.).

Keep us updated!