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

[Denis9001 - 2007]

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.

Nice one Wes. Are you a consultant by any chance?

I'll go one step further. If you ditch the certification the NCR's go out of the window with the registrar. So you won't need a consultant to to help work out solutions to the NCRs either. You can then consider investing the consultant fee on a few beers to help you get over the headaches your problem has given you.

 

[ralphsulser]

Throwing it out the window may not be an option. I don't know anyone prusuing TS16949 with out a customer mandate, and target date for completion. Whoops, sorry, thought it was TS, just realized it is ISO9001

 

[danzio]

I have been in contact with the registrar. I felt I was in trouble when on my initial contact with them, I explained the situation with my QA Manager and her immediate response was, "Well just because you lose your ..... doesn't mean your whole system should fall apart!" I asked for an extension yesterday via email and the reply was: "I am not certain that we can extend this. As I have stated earlier, all recertifcation audits are required to go 2-3 months prior to expiration.
As of right now, the audit is set for 9/19-20, only 10 days before the certificate expires.

I am fairly certain that if the recert takes place after the certificate is expired that its required to go through full registration time.

I will check with my Program Manager and get right back to you."

I have not heard back yet this morning.

Anyway, yesterday I spent a couple hours looking for the ISO manual and I can't even find it. I think my guy may have run off with it.

I appreciate all the replies received and I am not yet giving up but I do believe I am not going to be able to recover from here without some outside help. How does one find a good man and avoid the "sharks" as Wes put it?

BTW, based on the statement from the registrar above, if all recertification audits are "required to go 2-3 months prior to expiration" haven't they violated their own policy by waiting until just 10 days prior to expiration to schedule the audit?



Denis9001,
I like your approach, you wouldn't be a brewmaster by any chance now would you?

As far as the NCR's they are all minor, two are in regards to violations on our website, one for using the ISO logo, another for claiming to have design services when in fact we claim exemption to element 7.3. Even though we do outsource some design work. I do not quite know how to get around that one. My former QA manager said if we had to be compliant to 7.3 it would open up a whole new set of problems so how do we handle that. An auditor will eventually stumble upon an order that has the word "design" in it and were busted. Is it better to just wait until that happens?

The other 2 NCR's are for not obtaining "objective evidence" for customer satisfaction and finally utilizing a non-approved supplier for outside services. There it is.

Thanks for listening, just being able to vent seems to help. Even if it's only therapeutic.

 

[ralphsulser]

The comments fro your registrar don't seem to be providing customer service help. Is this someone in authority or an auditor? Not the kind of attitude expected for your efforts and forthright communications. if you don't need to be registered to ISO9001 by a customer consider dumping the process, and call your system ISO 9001 compliant. The minors you listed don't seem to be any big deal. There are several manuals posted here that you may be able to use for guides.

 

[Denis9001 - 2007]

danzio

Don't sound like a big problem to me.

NCR1 - ISO logo. That's not really a ISO9001 NC but a breach of your registrars rules and regulations for certification. Solution simple. Remove the logo or make the website "under construction" when the auditor comes. You should fix this NCR though because they can follow up anytime. Not really a hard one to fix. Betcha you forgot to put the certificate number on the logo or used the ISO logo as opposed to your registrars certification mark.

NCR2 - This is a common problem. No way you can include design in your system. it's very complex clause. The trick here is to shift your design service to suppliers/subcontractors. Reword your website so you don't claim you do the design. You say "we offer" and not "we do". Now all your designers should be in your approved vendor/subcontractor list. Maybe you don't have time to do evaluation records for them. So raise your own internal NCN on this. Maybe not having supplier records will get you a minor but hey...this is a kwik fix. Strictly speaking if you have noticed a problem and it is under the control of your QMS (ie a internal NCR and corrective action request) the CB (certification body) shouldn't raise a NCR because it is already identified and is under control. You should also "sanitize" your other records so there is no paperwork to indicate the design work was done in-house. If your staff did the design it may be a smart move to add them to your subcontractor list and explain that they did it as freelancers and not as part of their job duties. Once you have shifted design to purchasing you are out of the tricky clause.

NCR3 - Using a non-approved supplier. easy-peasy. bang him on your AVL and create related supplier record.

NCR4/5 - Customer satisfaction is an awkward and difficult clause. No idea what they mean by "objective evidence". It's subjective. Anyhow. Not sure what your method is for measuring satisfaction. The popular method is survey...yawn...as if we don't have enough. the other way is to have indicators which would indicate the level of satisafaction. So you have a simple spreadsheet with indicators like... complaints received, late deliveries, average order turnaround, repeat orders etc. A lot of this shoudl be available and really you should do this as it is a good way to monitor your business.

I am mindful that the clock is ticking and you really need just a band aid to get through the assessment. If kwik fix wanted. Knock up a questionairre. Don't spend much time. Once you have it you cannot get a major but maybe a minor. Then do a telephone customer survey. Of course you dont have time. So just bung in customer names/phone numbers from your records and tick away the responses yourself. The auditor cannot phone your customer to verify. he is not allowed to. backdate the date of call and have the person who made the call sign off the form. I would not use paper but knock up a access database quickly. maybe you dont have the tech skill so paper is fine.

You were a bit vague on these satisfaction ncr's so cannot help too much.

This should scrape you through. As said if what you do looks poor. raise you own NCR and CAR to show that action is underway. You could even claim that records were stolen by the previous quality manager and raise a NCR about record safety.

The missing QM maybe a big pain. Get one of those fill-inthe-blanks ones from the net. You can call the old Quality manager. Not as the company but as you personally and plead with him to help you out of a jam, save your job and tell you where the manual and docs are.

OK that's my emergency solution. But I stress. You should get your system in order and do proper fixes for these problems. By the way, the website ncr's will disturb the auditors most because they are seen publicly and can rebound on the auditors/CB.

Good luck...

 

[Sidney Vianna]

Registrars have to follow requirements as well. It is correct to plan the re-certification audit sometime in advance of the expiration of the validity of the certificate, so any issues arising from the re-certification audit can be resolved prior to the certificate “ceasing” to be valid.

I believe that being forthcoming and open with your registrar is definitely the right approach, but if the system is not implemented, one should not expect to be certified. From your comments, your system was based on 1 individual. What contravenes a basic premise of what a quality system should be.

My suggestion to you, at this time is: Call your registrar and ask for a voluntary suspension of the certificate. Tell them that you will call them, when you are ready to resume the certification program. Decide if you need external assistance or not to put a system in place. There are plenty of knowledgeable, professional people here in So-Cal. But since you are listed as the president of the company, you might want to build your system with your own internal resources. It is doable. It might take a little longer, but you will ensure that a true system exists.
Concerning the actual findings you listed, I did not see the ISO logo in your website. So, I assume that you already fixed that. But even if it was there, it should have not been written up. Auditors are supposed to identify misuse of the certification mark, not the ISO logo. Once again, using the ISO logo is prohibited by ISO. See http://www.iso.org/iso/en/iso9000-14000/certification/publicizing/index.html but should not be written up as a finding during an ISO 9001 audit, imo.

The Design issue definitely must be resolved. It needs to be clarified in your manual as part of the Scope of your Management System. Either done in-house or outsourced, if you sell design services, you will definitely need to find ways to comply with ISO 9001 7.3. PS. Seems that the word excelled is misspelled in your website – exelled –

Good luck and, like Wes said, relax.

 

[Denis9001 - 2007]

ralphsulser is spot on about your registrars attitude. What a snotty b***h. I'd like to see her training records and evidence of competency in ISO9001 and customer comminications.

Another option you can consider is changing to another registrar. Really it all boils down to cost and the number of audit man-days required. One thing you should be aware of is that if you change registrars it is considered as a "transfer" not an initial assessment so the man-days required should be less than if an initial. Maybe not an option for you and maybe you would need to bang in your application (or get quote) before your certificate expires. Worth a phone around maybe to compare prices.

Hey I'll certify you. My fees are peanuts (thailand rates) but you won't like the travel expenses. or I'll get our head office in UK to do it. Where are you? Miami, Vegas. I'll even buy the beer after the visit.

 

[jaimezepeda]

the missing manual

danzio,

Welcome to The Cove

As far as the missing manual, your registrar should have a copy of it as part of their past audit records. They have to have one from your original registration audit (desk audit). Granted any copy the registrar has is not the "controlled" document it would help you recognize what it looks like and where it could be at your organization.

Also, it is likely one of your customers asked for a copy of the quality manual in the past as they certified you as a supplier. You may be able to find a copy with one of your customers.

Jaime

 

[lrowe]

What a Great Group!

My only comment is that first I agree with nearly all the advice given for this situation. Second, what a great group of folks to try and help out!

Way to go Covers!!!

 

[WALLACE]

Welcome Danzio
The bottom line here is that, your organization is the registrars client, and in being a client, you may want to remind the registrar's contact of this fact.
If you're inheriting a messed up system that, merely pays lip service to the intents of the ISO 9001 standard, I emmpathize
I certainly don't think you should panic, Sydney's points are very valid too, your registrar may be following a defined and contactual process.
Regarding time to get your house in order, I'm certain you may be able to gain permission of more time for organizing your system.
Rox gave great advice too, step back and look at your existing system and gain a big picture view of what you've actually got. You may indeed be in a position of deciding to re-boot your quality system, defrag and reframe.
Wallace.