AS9100 Audit Coming up and We are Behind in a Few Areas!

[MNMachinist]

Well...

Like may have happened to some of you at one time or another, our AS9100 registered QMS has fallen behind in a few areas. It is doing well in most areas, but a few key areas have fallen behind. The reason for our slide is 2 fold: a lack of management resources during a Slump to Boom phase in our companies life and an unsustainable Quality Manual pushed on us by our Consultant (who i hate). We are a small company (17 people when we were registered) but are growing fast, largely due to our AS9100 Registration.

We state that we have a MGMT Review Meeting every 30 days. We missed 5 of them in the first half of the year. Also our Corrective Action Records, especially for suppliers, are light to nonexistent during that same time frame.

7.x, 6.x and 4.x are in pretty good shape, but we are behind on a couple things (mentioned above) in the 5.x and 8.x sections.

Over the last 4-5 months we have added resources to MGMT and so are getting back on track with all of these areas, but we still lack a complete set of records.

I am wondering if any of you have gotten themselves (or been stuck) in a similar situation or if there are any auditors out there that could comment on what I am in store for? Do you think I am facing a Major:mg: Non-Conformance for any one of these? Also what would be required as far as Corrective Action for these types of Non-Conformances? As i said we are on track now, but clearly lack records from the first part of the year.


BTW, I love Elsmar!!! Great Resource.

 

[DannyK]

Re: AS9100 Audit Coming up

I would suggest the following:

1. Modify your manual and procedures to induicate that management reviews are done quarterly or with a frequency that is more suitable.

2. Perform a thorough internal audit and issue the findings.

3. Answer all the corrective actions and institute a plan to resolve the issues.

The AS9100 auditor will at least see that you have identified the issues and are on track to deal with them.

You may want to try to simplify your system to make it more manageable.

Danny

 

[Wes Bucey]

My opinion:
It is acceptable to "modify" your QMS and documents which support the QMS (manual, procedures, work instructions, etc.) as a part of your continual review, evaluation, and improvement efforts.

You would not be the first (nor the last!) organization to realize "adapt or die" is not merely an empty motto.

I regret the consultant you hired overburdened your organization with excessive "rituals" more suited to a much larger and more systematically oriented organization than yours. In his defense, he may have thought he was laying the groundwork for your organization's eventual growth. Regardless, that's history and can't be recalled. You must move forward and take care to think through the changes you design and implement to reduce the possibility you will put yourself in a similar trickbag.

 

[Randy]

An astute auditor will probably be able to determine that you have failed to maintain your system as required in clause 4.1,,,,,the word "maintain" actually means something. Management "commitment" or evidence of lack thereof also comes to mind.

Based upon what you provided any corrective actions will be stopgap at best and probably without substance unless correction goes real deep.

Please don't be surprised with what your auditor comes up with...it's self inflicted.

Regardless of organization size, circumstances, changes or happenings the system must continue to function effectively and "management of change" is a big part of it.

 

[MNMachinist]

Please don't be surprised with what your auditor comes up with...it's self inflicted.

Regardless of organization size, circumstances, changes or happenings the system must continue to function effectively and "management of change" is a big part of it.

Oh Randy, thanks so much for the criticism of the business I saved from failure and summing up all my hard work with a "It's your own fault and never let the QMS slide, EVER!"

I know it is our fault (mostly mine) that we are behind. It is not an accident, it was a conscious choice. When I look at an empty bank account, an operating line of credit almost maxed out and the amount of work dwindling, I had to make hard decisions. I defend my choices by looking at the growing company we have built in the last 5-6 months from the doldrums of ruin the previous 1-1/2 years foretold. We all know a QMS takes resources to manage and fully support. When the creditors started calling i decided we needed to divert resources from the QMS to sales and production. IMO that is how it always should be. Never support the QMS when facing financial ruin, at least not at our size where I was the Quality Manager, the Management Rep and the President (not to mention the Operations Manager). I had to lay-off or redeploy a large portion of our resources to trim us down enough to get through the rough time. Without those actions I would probably not be typing this to you today.

I guess the reason for this response is to let you know your criticism offended me by belittling my hard work and the hard decisions I made regarding my friend's/employee's jobs. And also to encourage reservation of judgment of that which you do not understand, we all come from unique situations. Most of us in this community come here looking for help, not insult or blame. I understand your 'straight talk' gets you praise, but when you throw out civility for shock value, a re-evaluation is in order.


Thank you to the other responders. I have been spending the last two months or so catching up where I can as well as re-evaluating the Quality System to make it more appropriate to our operations, product, customers and size. I look forward to the auditors assessment of the changes.


:thedeal:The main motivation for this post was to understand the possibility that these things may constitute a major Non-Conformance. A secondary motivation was to understand what the consequences of a major non-conformance are so I can prepare my staff to deal with them after the audit.

Thank you in advance for your responses to my principal concerns.

Again I really enjoy the Elsmar Cove and the resource it provides to us working through QMS implementation and maintenance.

 

[Randy]

There was no fault or blame intended or belittling, if you want to take it that way so be it....What should have been done to begin with was proactive management using the Preventive Action process by identifying the root causes and developing solutions for them instead of waiting for the failure to occur (or choosing to let them occur as you stated).

Get the personality and passion out of the process and look at things objectively and approach them in an objective fashion.

You asked for comments from an auditor...I'm an auditor and I commented. Would you have liked it better if I had said "Don't worry, be happy and eveything will be fine and all that has happened will be forgiven and overlooked"? My statements were made from evidence you provided and not from what I guessed.

The consequences from a major? Possible suspension and revocation of your certificate..........That's the result of conscious choice.

Deal with the issues before the audit, don't wait. Perform all the CA as necessary and PA where it can help.

 

[BadgerMan]

The main motivation for this post was to understand the possibility that these things may constitute a major Non-Conformance. A secondary motivation was to understand what the consequences of a major non-conformance are so I can prepare my staff to deal with them after the audit.

It sounds like you have made some tough choices and I can identify having been in such a position in the past. Hang in there and do not fear the auditor’s findings regardless of severity. At the end of it all, you and your management team will be given the chance to rectify the situation and retain your certification. Continuous improvement and corrective actions are all part of the process. Possibly the most valuable lesson learned will be to use you own internal processes to become more proactive. Keep us posted regarding the outcome.

 

[E Wall]

While I am not an Auditor or involved with AS what is at risk is your certification and customer base. Not easy to swallow hearing direct responses sometimes, but an auditor is reacting to the facts of what is; which is where Randy's comment (in my opionion) was directed. If we can put ALL the ego's in check, I'm certain civility can still reign.

The business decisions being made clearly came down to have the cert but no business or a business with "possibly" no cert. The key question now is what can be done prior to the audit to provide the 'stopgap' as pointed out on the process/system failures you are aware of. Also, if you go into the same level of detail with your auditor as you did with Randy's comment...be prepared to respond to the auditor on how in future, if your business is at risk of failure you would react next time.

Please keep in mind, the auditor has clear guidelines that are put in place to protect the customer (and to a larger scale the public at large depending on your product). System failure(s) leave a lot of gaps that put your customers at risk. The risks necessarily vary based on the process. If you provide for responses showing what was taken into consideration and why; you should end up with a good dialog on the situation.

Eileen

PS: Good basic rule of thumb to share with staff is not to volunteer information.