For the document review, he spent 20 minutes going through the first two paragraphs of the Quality Manual saying "I don't understand what you mean". It is an exact duplicate of the standard backwards. ::arggg:::mad:

He also said that I have to specify how records will be dispose of, shred, trash, burn... I said that the Manager responsable for the record is responsable for disposal. He said that didn't say how it was disposed of... :bonk:

For the document review, he spent 20 minutes going through the first two paragraphs of the Quality Manual saying "I don't understand what you mean". It is an exact duplicate of the standard backwards. ::arggg:::mad:

He also said that I have to specify how records will be dispose of, shred, trash, burn... I said that the Manager responsable for the record is responsable for disposal. He said that didn't say how it was disposed of... :bonk:

did he say if he's going to give you any findings or observations based on those two things?

As to the first one- prove to him that you're employees know what it means, he should have no issue. It's FAR FAR FAR more important that the employees understand something than an auditor.

He wrote us up for procedures that he said that he didn't receive, and then told me he had two copies.

BTW he told me that he just "skimmed" the procedures, and had some problems with things he didn't find. I had to sit there and tell them where they were..... :mad:

I forgot to mention, the Quality Manual that we used is one that I got here. Only the names, the Quality Policy, and the procedures referenced changed.

MsHeeler

If I were you, I´d contact the CB and ask for a change... if he´s like this in your Document review, imagine during the audit itself ! :mg:

Don´t be afraid to ask for an audit change...

If I were you, I´d contact the CB and ask for a change... if he´s like this in your Document review, imagine during the audit itself ! :mg:

Don´t be afraid to ask for an audit change...

Ditto.......and to think he got paid for doing that. The CB must have a lax competency requirement. They need to look at 6.2.2

Yes, Request a change of auditor. The initial document review shouldn't be that quick at all. He needs to really understand your companies processes if you are to expect a useful audit. If not, your going to be paying a ton of money for a glorified tour of your facilities and processes while wasting more time answering questions and keeping him on the right path rather then identifying problems.

Does he have any experiance in your industry?

Be careful with that record matrix though. That's an auditor’s number one tool and they don’t like things missing on that. Make sure its put together properly by identifying all requirements in 4.2.4.

Good Luck!

Andy

For the document review, he spent 20 minutes going through the first two paragraphs of the Quality Manual saying "I don't understand what you mean". It is an exact duplicate of the standard backwards. ::arggg:::mad: An exact duplicate of the standard turned backwards. Now I'm mad! :mad: What value does that give you? He didn't understand it ...I thought people did these kinds of manual so they were "auditor friendly." :notme:

He also said that I have to specify how records will be dispose of, shred, trash, burn... I said that the Manager responsable for the record is responsable for disposal. He said that didn't say how it was disposed of... :bonk: It is a requirement of the standard, if a bit picky to raise it as a NC.
The rest of the dealings with you indicate an insensitive side. If he hasn't received the documents he should contact you and ask you to resend.

Find another auditor / CB.

An exact duplicate of the standard turned backwards. Now I'm mad! :mad: What value does that give you? He didn't understand it ...I thought people did these kinds of manual so they were "auditor friendly." :notme:

It is a requirement of the standard, if a bit picky to raise it as a NC.
The rest of the dealings with you indicate an insensitive side. If he hasn't received the documents he should contact you and ask you to resend.

Find another auditor / CB.
Just an FYI:
The auditor is making a common error in his understanding of the meaning of the term "disposition" in the sense meant by the Standard.
For years, I have counseled clients to add this definition to their "Glossary of Terms" to forestall such situations as encountered by MsHeeler:

DISPOSITION - The actions taken regarding records which are no longer needed to support on-going administrative activities in accordance with the organization’s Records Retention and Disposition Schedule. Directions may include destroy, transfer to the organization’s Records Center, transfer to the organization Archives, transfer to inactive records storage space, or retain permanently in unit.

The point being the intended meaning of "disposition" in the Standard is NOT limited to destruction and/or disposal.

Thank you all for you replies. So I am not loosing my mind after all, that is great! :agree1:

The auditor has registered another plant in our company, but his company specializes in medical not production. I don't think he knows too much about it. I think he just wants us to use the other plants procedures so he dosen't have to read them. I'm not too sure that theirs meet the standard.

MsHeeler

Yuck!

I would interview a few auditors that have experience in any related fields to your company. You'll be doing you quality system no good having an auditor that’s trying to compare apples to oranges. What will wind up happening is he'll be barking up the wrong tree with his medical experience and missing chital improvement opportunities with the production side. Have your registrar send you bios or some other auditors that match your criteria closer and make sure you interview them before committing to any one of them so you don’t have to go through this again.

Good Luck!
:agree1:

One thing for sure, I'm not the Auditor:nope:

One thing for sure, I'm not the Auditor:nope:

That would be scarey! :notme:

Is that a gun? I guess my knife wouldn't help me much. ::lol::

That would be scarey! :notme:

Is that a gun? I guess my knife wouldn't help me much. ::lol::


:topic: That brings up an old, old story about the guy who brought the knife to the gunfight....I have a very nice knife scar on my left forearm. ;)

Thank you all for you replies. So I am not loosing my mind after all, that is great! :agree1:

The auditor has registered another plant in our company, but his company specializes in medical not production. I don't think he knows too much about it. I think he just wants us to use the other plants procedures so he dosen't have to read them. I'm not too sure that theirs meet the standard.

MsHeeler


Please, don't use another plant's procedures just because the auditor might like it... :nope: You don't want to put in a system for the auditor. Implement it to meet your needs...

He wrote us up for procedures that he said that he didn't receive, and then told me he had two copies.

[note, I am an auditor, and even I think...] "That is inexcusable." This guy does not appear to be a worthwhile auditor.


BTW he told me that he just "skimmed" the procedures, and had some problems with things he didn't find. I had to sit there and tell them where they were..... :mad:


That is not unreasonable if your Table of Contents is not very clear.


I forgot to mention, the Quality Manual that we used is one that I got here. Only the names, the Quality Policy, and the procedures referenced changed.


That does not make it good or bad. In fact, if you only changed a few names and links, I might be inclined to actually take off a few points...

... It's FAR FAR FAR more important that the employees understand something than an auditor.


Amen...I fully agree. It is your system.

His happiness is not the issue, your meeting requirements is.

It really doesn't matter what the auditor "likes", only what you do.

That would be scarey! :notme:


Randy IS scary :whip:

His happiness is not the issue, your meeting requirements is.

It really doesn't matter what the auditor "likes", only what you do.

I agree! I sent him an email asking him to let me know what items do not meet the standard so that I can fix them. I haven't gotten a reply... We will see.

We have had a discussion with the company that he works for... We will see on that too.

MsHeeler

Here is another question. He said that we can not state that documents on Contract review (Done at the Corporate Office) can be controlled by Corporate procedure. He said that we will have to write a procedure. ???

I told him that the corporate office is like any other subcontractor that is ISO certified. If they send us a certificate of compliance we can use that as a guarantee that the product is good. We have measureables to check the reliability. If they show us that they are not reliable we will ask for a corrective action. He said that this is reactive and not proactive. He did sort of crawfish on that, I'm wondering if he will bring it up again... ::sigh::

MsHeeler

...If they send us a certificate of compliance we can use that as a guarantee that the product is good. We have measureables to check the reliability. If they show us that they are not reliable we will ask for a corrective action. He said that this is reactive and not proactive. He did sort of crawfish on that, I'm wondering if he will bring it up again... ::sigh::

MsHeeler

We have an auditor with a similar attitude. He reluctantly accepts our practice of accepting C of Cs, but strongly encourages supplier audits. He would rather see more supplier audits than C of Cs.

My :2cents: : If your auditor is like ours, he most likely will bring it up again...and again...and again....until he sees more supplier audits being performed.

We have an auditor with a similar attitude. He reluctantly accepts our practice of accepting C of Cs, but strongly encourages supplier audits. He would rather see more supplier audits than C of Cs.

My :2cents: : If your auditor is like ours, he most likely will bring it up again...and again...and again....until he sees more supplier audits being performed.

It has become painfully obvious that he is not out for added value to us, but added value to his bank account.

Does he realize that he himself certified our corporate office. Now I am not so sure about their reliability... :lmao:

BTW have you ever heard of a 5 day audit for a facility with 80 employees?:nope:

MsHeeler

BTW have you ever heard of a 5 day audit for a facility with 80 employees?:nope:

MsHeeler

Wow! That sure is a long audit.

Are you doing a initial gap analysis with these guys? or have employees with proceedures that travel? Ours took 4 days with the auditor late 2 of the for and we did a site visit that was 30 miles away and we have 100+ employees.

Just one more reason to look somewhere else I suppose. :yes:

Here is another question. He said that we can not state that documents on Contract review (Done at the Corporate Office) can be controlled by Corporate procedure. He said that we will have to write a procedure. ???

I told him that the corporate office is like any other subcontractor that is ISO certified. If they send us a certificate of compliance we can use that as a guarantee that the product is good. We have measureables to check the reliability. If they show us that they are not reliable we will ask for a corrective action. He said that this is reactive and not proactive. He did sort of crawfish on that, I'm wondering if he will bring it up again... ::sigh::

MsHeeler

It would be rather difficult for you to write a procedure for a process you do not perform... A reference or link to the corporate procedure sounds just fine. (lose this guy and let him practice on someone else...)

It has become painfully obvious that he is not out for added value to us, but added value to his bank account.

Does he realize that he himself certified our corporate office. Now I am not so sure about their reliability... :lmao:

BTW have you ever heard of a 5 day audit for a facility with 80 employees?:nope:

MsHeeler


Actually, 5 days sounds in the ballpark for an initial assessment with 80 employees.

I agree with all of you! I want to get a new guy, but the Management Rep wants to use him for now since he is the one who certified our corporate office. I think he just wants to beat him up some. I don't know... :bonk:

He said that between him, me and the guy who is coming in, the guy should be in tears before the 2nd day. I'm not too sure that is a good idea, but it is not my call. :nope:

Oh well, maby it will be fun
MsHeeler

We should get Randy down here!!! :lmao:

AMAZING NEWS!!!

Just got an email from the registrar on the document review. After yesterday's discussion with him :mad: and a call to the company he works for, he sounds like a completely different person. Everything has been accepted. There were a few suggestion... but ok!

Huge Crawfish!!!

MsHeeler

And he didn't even see my knife yet Randy! :whip:

Originally Posted by MsHeeler



BTW have you ever heard of a 5 day audit for a facility with 80 employees?

MsHeeler

My whole company and me in particular has a zero tolerance policy on incompetent auditors.
We are in the quality software and consulting business so none of the managers show any mercy when an auditor implies they must do something because the standard requires it and they are full of hooey.
We changed registrars after 3 years because the auditors were so awful.
If I am getting an auditor we have not seen before I ask for their resume.
On an informal note I judge an auditor by their findings and if they say at least one thing during the audit that catches my attention and gets me thinking about something I haven't considered before I think that is great.
We are a small company, under one hundred people in the US Corporate office and we have the practice of inviting the entire company to the opening and closing meeting. People are really invested in how we do and want to hear exactly what the auditor has to say.
The good auditors love the idea, the bad auditors quake. One even told us it was not permitted under the standard.
I just finished a long ugly move from Florida back to NY and have missed all the interaction here at the Cove. It is great to be back home in NY and great to be back in the thick of things at the Cove.
Regards,
Mary

I agree! I sent him an email asking him to let me know what items do not meet the standard so that I can fix them. I haven't gotten a reply... We will see.

We have had a discussion with the company that he works for... We will see on that too.

MsHeeler

OK, I'm coming into the sandbox a little late on this one...
Disclaimer: please accept the following as an opportunity for future improvments, not a negative judgement on past performance:

Why do people allow their auditor to walk out of the facility if things are not clear to them? I have been guilty of this myself to some extent....mostly on the 14001 side when the MR for environmental did not clarify something (and I didn't cuz I'm not the MR there, just the hmmm...what am I? fall guy (girl)?) stupid me...won't happen again.

Make sure you understand exactly what is meant, keep asking until you do. If you absolutely cannot talk the same language with the auditor sent to you, ask for someone else next time.

Originally Posted by MsHeeler

BTW have you ever heard of a 5 day audit for a facility with 80 employees?

Regards,
Mary


You betcha. I have one scheduled that is a 6 day EMS reassessment for a facility with 70 employees. Me and 1 other auditor for 3 days onsite = 6 days

Got an email from the auditor. Wow, all of our documents have been accepted! Big suprise... he got chewed out by the company that he works for, because of several items.

The Quality Manager and I have decided that he has very little time while he is here to prove that he is not an idiot or we will send him packing. :mad: I wanted to ask for someone else but...

I will stay in touch! :thanx:

Got an email from the auditor. Wow, all of our documents have been accepted! Big suprise... he got chewed out by the company that he works for, because of several items.

The Quality Manager and I have decided that he has very little time while he is here to prove that he is not an idiot or we will send him packing. :mad: I wanted to ask for someone else but...

I will stay in touch! :thanx:

Thanks for the update, MsHeeler. Interesting development, for sure...

Hang in there with me, I may need emergency assistance during the audit! :eek:

MsHeeler

He either got "chewed out" or he decided to wake up and smell the coffee !!!

Good luck during the audit !!

Ok, a specific question. :rolleyes:

On control of records. Records that are created by a corporate function and kept at a corporate facility, on retention and disposal, is "per corporate procedure" acceptable?

Ok, a specific question. :rolleyes:

On control of records. Records that are created by a corporate function and kept at a corporate facility, on retention and disposal, is "per corporate procedure" acceptable?

Is this record evidence of an activity performed at the address where you are?

These are records for design (customer specified), prints, inspection criteria all of this is done at another facility. The finished product, prints and inspection forms are on the network for us to use. (also per corporate procedure).

MsHeeler

Ok, a specific question. :rolleyes:

On control of records. Records that are created by a corporate function and kept at a corporate facility, on retention and disposal, is "per corporate procedure" acceptable?

If Corporate is certified, and subject to regular audits, it probably would be fine.

If they are not certified, and the record is not relevant to the local system, it would probably be OK.

However, if Corp is not certified, and the record IS relevant to the local system, it should be probably be listed on your record retention list.

As an auditor, I would not beat this to death. But, if it is important, i.e.: Corrective Actions, Hiring or training records, I think I would want them listed.

If Corporate is certified, and subject to regular audits, it probably would be fine.

If they are not certified, and the record is not relevant to the local system, it would probably be OK.

However, if Corp is not certified, and the record IS relevant to the local system, it should be probably be listed on your record retention list.

As an auditor, I would not beat this to death. But, if it is important, i.e.: Corrective Actions, Hiring or training records, I think I would want them listed.

The corporate office is certified, the auditor thinks that we should state what their procedure is. I don't believe that this is necessary, if there is not a problem with their procedure. If there is a problem it will become evident and a change will have to be made.

We treat them as a subcontractor and have measureables to judge their performance. :whip:

Does this sound like a good answer?

MsHeeler

The corporate office is certified, the auditor thinks that we should state what their procedure is. I don't believe that this is necessary, if there is not a problem with their procedure. If there is a problem it will become evident and a change will have to be made.

We treat them as a subcontractor and have measureables to judge their performance. :whip:

Does this sound like a good answer?

MsHeeler

It might not hurt to reference a link to it, but I wouldn't care either way. Generally, they would be considered a linked process, not a subcontractor. In fact, in TS, that would be required.

BTW have you ever heard of a 5 day audit for a facility with 80 employees?:nope:

MsHeeler

Yep...one facility, one department (not a company), 5 sections within the department, about 40 employees...1 day for document review, 1 day for familiarization to explain/show what we do..which i still have difficulties comprehending (at my request) and 5 days of audit (at my request)...since we failed (see my other post), we have scheduled addtional 2 days of re-audit...and am i hopeful? :notme:

well, am sure we will get our certification but......what can you do, huh? :bonk:

All I can say is...it was a learning experience...

newbie poster here-

5 days for an audit. heck no!

I am in a medical device mfg company of 300+ and we are audited to a number of regs. easly complete in 3-3.5 days

newbie poster here-

5 days for an audit. heck no!

I am in a medical device mfg company of 300+ and we are audited to a number of regs. easly complete in 3-3.5 daysWell it depends. What "regs" do you get audited to? How many auditors are involved in these 3-3/5 days? Obviously if you have 2 auditors for 3 days, that adds up to 6 auditor-days.:tg:

I checked your ISO 9001 and 13485 certificates online. I find interesting that your ISO 9001 certificates were issued under EAC Codes different than the one that ANAB uses to describe Medical Devices: #40. It could be a coincidence but your CB for ISO 9001 is not accredited for Code 40 with ANAB, according to their Directory, http://www.anab.org/Directory/Directory_Search.asp
Maybe you want to ask them about this.

Our previous registrar had their MD 9001/13485 abilities revoked. :mad: :bonk:

The certs you viewed are in the process of being updated and replaced with our new certificates. :cool:

Yep...one facility, one department (not a company), 5 sections within the department, about 40 employees...1 day for document review, 1 day for familiarization to explain/show what we do..which i still have difficulties comprehending (at my request) and 5 days of audit (at my request)...since we failed (see my other post), we have scheduled addtional 2 days of re-audit...and am i hopeful? :notme:

well, am sure we will get our certification but......what can you do, huh? :bonk:

All I can say is...it was a learning experience...

Where was the failure? :bigwave:

Just Curious
MsHeeler

Ok, new question...

Our registrar wants to audit our corporate office for sales and marketing. Where is the shall? Did I miss that?

He also wants to audit them for Materials Management and Purchasing. We only state that they are responsable for the Approved Suppliers list. I can see that part but...

He wants to audit the warehouse for "purchasing process and purchasing information, order entry for "product service and provision", document control for "verification of purchased product". But he is not wanting to audit process engineering for "determination of requirements related to the product"

I think he has been drinking. :bonk:

Anyway any opinions on the Sales and Marketing?

MsHeeler

newbie poster here-

5 days for an audit. heck no!

I am in a medical device mfg company of 300+ and we are audited to a number of regs. easly complete in 3-3.5 days


You may be missing the point. In ISO certification land, the auditors don't get to pick how many days the audit will be. It is mandated by official lists and we have to work to those to maintain certification. Other regs (like GMP) may not have that requirement.

Ok, new question...

Our registrar wants to audit our corporate office for sales and marketing. Where is the shall? Did I miss that?

He also wants to audit them for Materials Management and Purchasing. We only state that they are responsable for the Approved Suppliers list. I can see that part but...

He wants to audit the warehouse for "purchasing process and purchasing information, order entry for "product service and provision", document control for "verification of purchased product". But he is not wanting to audit process engineering for "determination of requirements related to the product"

I think he has been drinking. :bonk:

Anyway any opinions on the Sales and Marketing?

MsHeeler

The processes and activities defined by your Quality Manual must be audited, wherever they are performed. If Corporate or the Warehouse perform functions defined by your QMS, they would need to be audited from time to time. If not, they typically would nt be.

Unlike the old ISO, we are auditing a whole system here, not just your facility. How this applies to your particular situation would need to be reviewed. We don't have enough info here to make a firm decision.

You may be missing the point. In ISO certification land, the auditors don't get to pick how many days the audit will be. It is mandated by official lists and we have to work to those to maintain certification. Other regs (like GMP) may not have that requirement.

Yes! I am aware of this, 5 days seemed a bit lengthy. I was only responding as being suprised :)

Anyway any opinions on the Sales and Marketing?Sales, more than marketing, has a clear impact on the QMS. If the processes are "outsourced" to a corporate office, how do you ensure that what they do comply with the applicable requirements of ISO 9001?
Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system. Even though you might have not "chosen" to outsource them, the premise applies.

You may be missing the point. In ISO certification land, the auditors don't get to pick how many days the audit will be. It is mandated by official lists and we have to work to those to maintain certification.There are no mandates. There is a "method" for estimation of auditor-days, based on Annex 2 of the IAF Guidance to ISO/IEC Guide 62 document. It is a well known fact that some CB's lo-ball the auditor-days in order to offer a lower quote to their prospects. There is WIDE variance of estimation of auditor days in this business.

Maby I asked the wrong question. What part of the standard would be audited for Sales and Marketing?

MsHeeler

Maby I asked the wrong question. What part of the standard would be audited for Sales and Marketing?

MsHeelerThe one that is the obvious answer is 7.2, customer related processes. Once again, clearly for sales, not so clear for marketing.

I see your point, only we do all of 7.2 in "order processing and review" that is done in house. Sales merely tries to get them to send us the order. We don't even mention them in the procedure.

MsHeeler

Question raised by auditor:

Do you have a list of external documents? He is refering to the Standards, FMEA, MSA and other manuals. What is the best way to "control" these? In our "control of documents" this is not covered. We have one copy of each manual. Would it be enough to say that these manuals are kept in Document Control and distribution is only as needed? There has got to be a better way without reinventing the wheel.

Thanks
MsHeeler

...
There are no mandates. There is a "method" for estimation of auditor-days, based on Annex 2 of the IAF Guidance to ISO/IEC Guide 62 document. It is a well known fact that some CB's lo-ball the auditor-days in order to offer a lower quote to their prospects. There is WIDE variance of estimation of auditor days in this business.

Thanks for the clarification. In TS (and QS), the audit days were mandated. I was under the understanding that Guide 62 were required minimums, though I realize some CB's low ball it.

My CB's require that I use their adaptation of the audit day lists, so I don't actually refer to Guide 62 very much.

Question raised by auditor:

Do you have a list of external documents? He is refering to the Standards, FMEA, MSA and other manuals. What is the best way to "control" these? In our "control of documents" this is not covered. We have one copy of each manual. Would it be enough to say that these manuals are kept in Document Control and distribution is only as needed? There has got to be a better way without reinventing the wheel.

Thanks
MsHeeler

I believe this could be addressed by including them in your company's master list of controlled documents, stating as you mention where they are located, rev. level, etc. In our company, this master list includes external standards (federal & international), documents, technical files, forms, procedures, work instructions, formulas/recipes, specs, etc.

Hope this helps...:)

The one that is the obvious answer is 7.2, customer related processes. Once again, clearly for sales, not so clear for marketing.

Marketing cover some if the 7.2.3 stuff in customer communications, brochures, web sites, advertisements etc. They are also often responsible for a lot of the deployment of customer focus (5.2).

Question raised by auditor:

Do you have a list of external documents? He is refering to the Standards, FMEA, MSA and other manuals. What is the best way to "control" these? In our "control of documents" this is not covered. We have one copy of each manual. Would it be enough to say that these manuals are kept in Document Control and distribution is only as needed? There has got to be a better way without reinventing the wheel.

Thanks
MsHeeler

Generally with external documents you hold the necessary copies and distribute to other departments as necessary. As revision is under the control of the publisher it is only your responsibility to periodically check that you have the latest issue and control any changes by withdrawal and reissue.

For TS manuals it is just a case of checking on the AIAG web site every so often.

I believe this could be addressed by including them in your company's master list of controlled documents, stating as you mention where they are located, rev. level, etc. In our company, this master list includes external standards (federal & international), documents, technical files, forms, procedures, work instructions, formulas/recipes, specs, etc.

Hope this helps...:)

We would have to rewrite the "control of documents" procedure to do this. We state that the procedure covers procedures, work instructctions... they are stored electronically, they are controled... ::sigh::

I think my suggestion should work, I will get the auditors opinion today and let you know.

We need a :crossed fingers: icon

Msheeler

We would have to rewrite the "control of documents" procedure to do this. We state that the procedure covers procedures, work instructctions... they are stored electronically, they are controled... ::sigh::

I think my suggestion should work, I will get the auditors opinion today and let you know.

We need a :crossed fingers: icon

Msheeler

I'll keep my fingers :cfingers: for you....(this icon is in the lower right corner of the smilies column when you type your reply.)

I'm hoping that he has forgotten about this, but if he hasn't I have a plan. I will mention "external documents" in the control of documents procedure and state that the manuals are kept in document control, and add them to our master list of documents as "external". This should work!

I will have to give a list of findings a little later, they are not too bad and I am fixing them as we go. "I'd like to see this" is one thing I never want to hear again.

So man fires, so little time!
Thanks for your support :biglaugh:
MsHeeler

FWIW - a master list of all documents is NOT a requirement of the standard. We maintain a list of our documents for our QMS, but we do not keep a list of documents of external origin. We do, however, have a process for verification of latest revision of these documents.

I think it will be easier to just make an addition to an already existing document, but I see your point. I will need to add something for verifying that they are current.

MsHeeler

I think it will be easier to just make an addition to an already existing document, but I see your point. I will need to add something for verifying that they are current.

MsHeeler

What is important is do what works best for you. I work for a job shop and we have over 5000 customer drawings on file. We would have to hire an army just to "log" these. Our process is to review the print rev to each customer order to verify we have the latest revision.

WOW! That sounds fun!!! I will be taking over our drawings, work instructions, quality inspections, etc. after the audit is over. I'm not sure how many there are, but there are a bunch. :truce:

MsHeeler

WE PASSED!!!!!

Ok here are the findings.

1. Not all records are stated in Control of Records.

2. Item on production floor not identified

3. No evidence that when measuring device was found to be out of calibration that and evaluation was made to see if products may have been affected.

4. No evidence that new pin gages are certified to a national or international standard.

Note: Beware, if you get a short cert from MSC direct, it is USELESS. MSC told be that it only shows that you got the parts that you ordered! :mad:

BTW - We state that we do not do design, so the auditor wanted to call the head of engineering at our sister company to interview him on product design. Wow! I could have written the auditor more minors than he wrote us! Yes, it was a nightmare. I had to argue points over and over again.

He told me that when he came back, if our Operator Work Instructions were not made a part of the Document Control System, he would write me a MAJOR. We state in Control of Documents that Operator Work Instructions were controlled using appropriate signatures. I argued this point at least 5 times in one day! Then he brought it up again in the closing meeting. I almost went across the table.

This man is an idiot! I could go on 10 more pages!

But I won't
MsHeeler

WE PASSED!!!!!



:applause: :applause: :applause: Well done and congradulations!!!!!

:applause:

CONGRATULATIONS !!

Don´t let your guard down now... keep the spirit up and don´t think you guys are "Superman".... there´s plenty of work still to be done as you can see by the audit findings ...

1. Not all records are stated in Control of Records.

2. Item on production floor not identified

3. No evidence that when measuring device was found to be out of calibration that and evaluation was made to see if products may have been affected.

4. No evidence that new pin gages are certified to a national or international standard.

Congratulations!:applause:

We received the same nonconformance as your number three during our AS9100 registration audit because when we sent a pin gage set out for calibration they replaced two of them.

More nightmares from the auditor! :mad:

Pre-Assesment Audit - Closed

We had no quality manual or procedures. He gave us twelve separate noncoformances for not have a procedure.

He just sent me the nonconformances and wants me to put the Procedure and revision dates that answered the nonconformance.

Documentation Audit - Closed

He sent me the "check list" to update the revision dates on the procedures.

Certification Audit - Over, Almost Closed

Just sent for signatures

So what should be my answer for the first two? Should I do it and send him a bill, or just send him a copy of the Master List of Documents?

MsHeeler

More nightmares from the auditor! :mad:

Pre-Assesment Audit - Closed

We had no quality manual or procedures. He gave us twelve separate noncoformances for not have a procedure.

Why 12 non conformances? How did you certify if you had no manual and procedures? He did the document audit, didn´t he say anything then? What documents did he audit? Sorry, but I´m confused...

He just sent me the nonconformances and wants me to put the Procedure and revision dates that answered the nonconformance.

Documentation Audit - Closed

He sent me the "check list" to update the revision dates on the procedures.

Certification Audit - Over, Almost Closed

MsHeeler

Just sent for signatures

So what should be my answer for the first two? Should I do it and send him a bill, or just send him a copy of the Master List of Documents?

IMHO, you should send the List of Documents and he should fill out the remainder of the NCR´s... but I´m still confused how he recommended your organization for certification if you had no procedures and Manual... :confused:

That was on the pre-assessment. I don't know what he was supposed to be doing, but all he did was say we needed procedures... :bonk:

We had everthing done when he came back for the certification audit.

MsHeeler

More nightmares from the auditor! :mad:

Pre-Assesment Audit - Closed

We had no quality manual or procedures. He gave us twelve separate noncoformances for not have a procedure.

He just sent me the nonconformances and wants me to put the Procedure and revision dates that answered the nonconformance.

Documentation Audit - Closed

He sent me the "check list" to update the revision dates on the procedures.

Certification Audit - Over, Almost Closed

Just sent for signatures

So what should be my answer for the first two? Should I do it and send him a bill, or just send him a copy of the Master List of Documents?

MsHeeler


I'm not clear why you would send an auditor a bill for answering nonconformities? I am also not clear why he would write nonconformities during a preassessment.

I'm not clear why you would send an auditor a bill for answering nonconformities? I am also not clear why he would write nonconformities during a preassessment.

Because these have already been answered and closed, he didn't do his paperwork and he wants me to do it for him. That is why I would send him a bill.

He wrote non conformities because he did a gap analysis as an audit, looked at nothing but the fact that there were no procedures in place.

MsHeeler

Because these have already been answered and closed, he didn't do his paperwork and he wants me to do it for him. That is why I would send him a bill.

He wrote non conformities because he did a gap analysis as an audit, looked at nothing but the fact that there were no procedures in place.

MsHeeler

Thanks for the clarification. He sounds like a fine addition to our noble auditing profession...:mg:

Because these have already been answered and closed, he didn't do his paperwork and he wants me to do it for him. That is why I would send him a bill.

He wrote non conformities because he did a gap analysis as an audit, looked at nothing but the fact that there were no procedures in place.

MsHeeler

I am confused if there were no procedures in place why did you aks him to come in?

WE PASSED!!!!!

MsHeeler

Sorry, I just read this .
CONGRATULATIONS !!
:applause: :applause: