Am I ready to call auditor?

[PVIJOHN]

1.1.1 The Corrective Action Coordinator will issue rework instructions as necessary. The supervisor of the area is responsible for carrying out the disposition of the product according to the NCR form.
a) Rework is sent to the appropriate process. Corrected product or material is subject to all product inspection required by the process to demonstrate conformity to requirements.
b) If disposition is “use as is” the item is placed back in the process.
c) When completed the NCR form is Transferred to QC to be filed and entered into the Nonconforming Material database.
d) In the case of customs all NCM will be scrapped and will be exempt from all procedures.
e) Scrap is logged on the Scrap report F-830-002 Scrap Report
5.21.2 If Nonconforming Product is detected after delivery or use, Quality Control or Management will contact the customer and take appropriate remedial action, and initiate a corrective action request form (F-852-001).
1.3 Sheet cut at the shears shall be scrapped without documentation as long as it is not due to operator error. Example (wrong cut lengths or as long as it has not been forwarded to the next step of process.) Material cut from drops will be exempt also, as long as it has not moved to the next process.
1.4 Test pieces will be allowed in areas as long as they are tagged not for production use. These parts may be used for machine set up only. (Bender presses, etc.) These parts shall be marked as set up part and then may be thrown in scrap bin.
That is a section of our Non Conforming procedure...1.1 D and 1.3 are the parts I think may be called into question.

 

[Al Rosen]

1.1.1 The Corrective Action Coordinator will issue rework instructions as necessary. The supervisor of the area is responsible for carrying out the disposition of the product according to the NCR form.
a) Rework is sent to the appropriate process. Corrected product or material is subject to all product inspection required by the process to demonstrate conformity to requirements.
b) If disposition is “use as is” the item is placed back in the process.
c) When completed the NCR form is Transferred to QC to be filed and entered into the Nonconforming Material database.
d) In the case of customs all NCM will be scrapped and will be exempt from all procedures.
e) Scrap is logged on the Scrap report F-830-002 Scrap Report
5.21.2If Nonconforming Product is detected after delivery or use, Quality Control or Management will contact the customer and take appropriate remedial action, and initiate a corrective action request form (F-852-001).
1.3 Sheet cut at the shears shall be scrapped without documentation as long as it is not due to operator error. Example (wrong cut lengths or as long as it has not been forwarded to the next step of process.) Material cut from drops will be exempt also, as long as it has not moved to the next process.
1.4 Test pieces will be allowed in areas as long as they are tagged not for production use. These parts may be used for machine set up only. (Bender presses, etc.) These parts shall be marked as set up part and then may be thrown in scrap bin.
That is a section of our Non Conforming procedure...1.1 D and 1.3 are the parts I think may be called into question.

I'm not sure I would state "exempt from all procedures".

 

[JaneB]

Can we claim Custom products do not require NC procedure. Product follows all inspections, and is matched to specs on print which has been approved by customer.

Why would you claim 'no NC procedure' for custom made products? You mean they never fail inspection? You have zero failures on custom-made? Hard to believe. If your NC procedure is too strict to accommodate custom-made, either modify it so it is, or ensure you cover off those requirements (Nonconformity) for those products in another! You don't get to just exempt mandatory requirements from the Standard I'm afraid. Otherwise, what you're saying to your customers in effect is 'we do ISO 9001, but we drop it when it comes to custom-made stuff'. Your auditor won't accept it, and neither would I (whether as customer or auditor).

A couple of things you now say are a bit of a concern to me: - you may not be fully understanding what is actually required and I strongly suggest you go back and re-read certain sections carefully, and satisfy yourself you're doing them and have the records/data to demonstrate that.
In particular:

We are "Auditing" our system daily.

No, you are not.

No one, but no one, audits 'daily'. Sounds like you're monitoring and observing it daily - which is normal - but that isn't audit. Go back and recheck what it says in the Standard! Just doing a single audit & fixing the NCs? Fine as a beginning/start out, but you need a planned and implemented program of ongoing audit.

Naturally, take into account all the stuff you are doing when planning & executing the program, but daily monitoring does not replace audit.

We hold a Management review three times a week if that means a half hour discussion over how the QMS is working, what it is showing us, how we can improve it and how we are doing on what we talked about two days ago.

Great - but have you got the required records that show this is happening though? per all elements in 5.6 so you can you demonstrate all required inputs & outputs? Again, this sounds like regular operational discussions - great - but don't overlook the requirements! (Also, those kinds of frequent discussions may miss the 'higher level stand back & consider' type of periodic review).

Is the auditor there to help us through the certification process or just give the okay. Is it a relationship or a you do this or else sort of thing.

Ultimately, their role is to assess whether you meet all requirements. Good auditors from good CBs are customer-focussed (theyr'e in a service business after all) but they still must do that assessment.

If you get a 'do this or else attitude', you need to change auditor or CB. That went out (or should have!) ages ago, though the odd dinosaurus still lingers on in the occasional pocket.

 

[JaneB]

We are willing to document a Specific Management review to satisfy the standard according to the schedule we set forth in our procedure, three times a year. I just feel it is a bit redundant as we meet, discuss, review, change, plan a couple of times every week. My bosses and i almost feel as if we are wasting our time drinking coffee going over things we already talked about...that in our case it is more bureaucracy than productive.

Then don't. Simply figure out a way to use what you do, be productive AND meet the requirements of the Standard! If you don't need extra meetings, don't have them!

As to being expected to be compliant to standard and our procedures, what about all the changes a new system undergoes, example; for first few months we attempted run QMS, Our inspection status of material was not easily determined as it went through the processes, as of two months ago it has been. In the beginning a lot of rejected welds were not documented, just sent back and fixed, now that is corrected, the list like that goes on and on, there are still many many things we wish to improve.

All very normal. That's what improvement's about!

PS Get some sleep and try to worry less.

 

[JaneB]

I guess, my main question is ( I am beginning to believe it is merely opinion and unanswerable anyway ) Where is the line when a System is "Certifiable".

When it is assessed as so by a competent auditor as meeting all mandatory and applicable requirements of the relevant Standard.

 

[John Martinez]

No. CAs resulting from internal audits do not have to be closed at the time of the registration audit. NCs raised during a registration audit by the CB must be closed prior to certification. Now, if there are open CAs and none have been closed and there's no verification of effectiveness of them, it could be a problem.

Better check with your chosen Registrar (CB) as I can tell you ANAB (Accreditation Body) required them to be closed.

I respect your expertise and experience; however, I'm going to have to agree to disagree and point out to the person asking this question to ask the CB that they have chosen.

 

[JaneB]

Better check with your chosen Registrar (CB) as I can tell you ANAB (Accreditation Body) required them to be closed.

Really? On what reasoning?

I've never ever had that experience with any of the CBs here and I've been through one heck of a lot of certification audits!

It would seem to militate against either raising CAs before certification audit or possibloy closing them too quickly, before there was evidence the action had been effective.

I'd much much much rather they be effectively acted upon rather than have people race to close 'em before certification audit.

 

[John Martinez]

Really? On what reasoning?

I've never ever had that experience with any of the CBs here and I've been through one heck of a lot of certification audits!

It would seem to militate against either raising CAs before certification audit or possibloy closing them too quickly, before there was evidence the action had been effective.

I'd much much much rather they be effectively acted upon rather than have people race to close 'em before certification audit.

Well looking over it again, perhpas not "closed" however, review for effectiveness. Yes, there could be a case where it was deemed "ineffective" and therefore had to be re-considered. Yes, not closed; however, review for effectiveness, YES, only on the initial COMPLETE system.

Lets be honest. Most folks putting in a system would not know "effective" if it hit them in the face. So, therefore, after review for "effectiveness", the NC would be "closed". That is why my original response; however, and technically, does not have to be "closed" but only reviewed for effectiveness.

Any ADDITIONAL audits, then would not need to go through the entire process.

8.5.2 Corrective action
The organization shall take action to eliminate the causes of nonconformities in order to prevent recurrence.
Corrective actions shall be appropriate to the effects of the nonconformities encountered.
A documented procedure shall be established to define requirements for
a) reviewing nonconformities (including customer complaints),
b) determining the causes of nonconformities,
c) evaluating the need for action to ensure that nonconformities do not recur,
d) determining and implementing action needed,
e) records of the results of action taken (see 4.2.4), and
f) reviewing the effectiveness of the corrective action taken.​

Thanks for keeping me honest, JaneB. I'll admit when I'm wrrrooooooooooo.

 

[John Martinez]

When it is assessed as so by a competent auditor as meeting all mandatory and applicable requirements of the relevant Standard.

Yes, agreed. I'd suggest you have your CB in for the "Stage One" audit or a readiness review. Your CB auditor will be able to tell the organization if the client is ready for the Initial Audit or it will need to be postponned.

The best thing we in the US has adopted from "across the pond" is the Stage One on-site audit. Benefits EVERYONE.

 

[JaneB]

Well looking over it again, perhpas not "closed" however, review for effectiveness. Yes, there could be a case where it was deemed "ineffective" and therefore had to be re-considered. Yes, not closed; however, review for effectiveness, YES, only on the initial COMPLETE system.

I completely agree that any CAs/PAs whatever should have been reviewed and appropriately actioned (whether before a certification audit or not). If I was an auditor, and found CAs raised some time ago that had not been addressed, or if closed, hadn't been reviewed (again, within a reasonable timeframe!) I would be asking questions about the effectiveness of corrective action. Of course.

But the very last thing that would help a CA to be effective would be any kind of rush to close it off, including a misbelief that the external auditor would expect that to be done! Indeed, I've encouraged clients not to close off CAs (or to re-open them) when they've been closed off too early, regardless of a scheduled certification audit. And auditors are happy (in my experience) when they see evidence of a functioning system.

Thanks for keeping me honest, JaneB. I'll admit when I'm wrrrooooooooooo.

You're welcome John, happy to oblige.