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Laura-2002
26th February 2002, 08:44 AM
OK peeps, once again the LAu needs your help.

I've just attended a pre-audit meeting.:(

They have four quality procedures and it was suggested that one of the procedures should not be audited because it was written in anticipation of something that is planned to happen and it hasn't happened yet.

I say the procedure should never have been published if this activity hadn't even happened, how do they know that the procedure is correct if they have never done it?

I say the procedure should have been documented as the activity happens (if it ever does). Alternatively, if the procedure had to be documented before the activity occurs then surely the procedure should be tested against the activity prior to publication.

A debate ensued as to whether an n/c should be raised against the procedure. Surely yes, b/c the activity hasn't even happened so there is no evidence that they are acting in accordance with the QP. I can't endorse compliance if they haven't even done the activity yet can I?

OK, boys and gals, I leave this one up to you!


:frust: :frust: :frust:

Lau.

HFowler
26th February 2002, 09:12 AM
Laura,

IMO, I would raise it as an observation the first time.

Best Regards,
Hank Fowler
:)

E Wall
26th February 2002, 09:46 AM
Lau...As described, I'd have to say that to me this is one of those damned if you do, damed if you don't situations.

My preferred approach is this for implementing a new procedure:
1. Identify what you 'believe' are the critical components.
2. Document and draft a guideline of what must be done, of course leaving room for logical discussion and real-time decision making if there was an error/miscaculation in the planning stage that nullifies a component.
3. Issue guidelines, providing contact listing as needed, under a deviation to be use the first time the procedure is needed. The deviation should direct WHO is to do WHAT and WHEN, including following the guideline, recording actual activities, and submitting data for review.
4. Review the information collected with all relevant parties...what they call in the 2000 version 'stakeholders' include reps from mgmt, supv, qa and operators. Tweek the procedure having it prepared and ready to issue under a deviation for the next time the procedure is used.
5. After repeating steps sucessfully, consider whether it is ready to be published as is, knowing that changes can be made if needed at a later date.

Personally, if the choice is having a unproven procedure or no guideline at all...I'll take the procedure! The key is to work together to fine-tune it for its intended use.

Best Regards, Ei

M Greenaway
26th February 2002, 09:56 AM
Hmmm a bit like the old chicken and egg.

What would you have done if they were performing an activity that they hadnt written a procedure for ?

Both things cannot happen instantaneously.

What clause of the standard would you have cited your NC against ?

energy
26th February 2002, 09:56 AM
Laura,

I assume that this is Internal Auditing. We have the same thing. Procedures have been written referencing other procedures and documents that are in the draft stage. Audit them, write them up and practice your Corrective Action Procedure. It's all practice for the real thing. I get written up for using documentation that we are in the process of making "official". I like it because it means that our auditors know the difference. Nothing personal. Go for it, Fishergirl!
:biglaugh: :ko: :smokin:

JodiB
26th February 2002, 10:16 AM
No finding. Don't audit to a procedure that isn't implemented. They have just prepared instructions-guidelines-procedures for when the new procedure IS implemented. If the existance of the procedure bothers you then ask for the timetable for implementation and schedule the audit for after that.

We're going to follow the same route that Eileen mentioned; our procedures are already written so that people will know how to do this new thing and released as "draft review". There is nothing that says you can't operate under draft procedures. After kinks are worked out, they are released for "real".

And like energy, in these new procedures we have references to other new procedures that (at this time) are either not written or are still in draft or draft review themselves. What else can you do? You have to start somewhere....

Al Dyer
26th February 2002, 10:23 AM
How about a wrtie-up under 4.2.3 Control of Documents??

energy
26th February 2002, 10:31 AM
Originally posted by Al Dyer
How about a wrtie-up under 4.2.3 Control of Documents??

That's exactly what we have done. It also forces you to get on the stick in regards to releasing the documents. You get practice in issuing CAR's and measuring "effectiveness". It's like a scrimmage in a football game. And, this is a game. Yes, it is. You know it is. Uh Huh. Yup.:biglaugh: During an interview with a possible Registrar, he expects to see a lot of CAR's during this getting ready process. A lot of em! Over time, they expect to see a decline as procedures take hold. This type of n/c is like a memorandum reminding employees that we have a system and we better start following it! No biggee! :ko: :smokin:

M Greenaway
26th February 2002, 10:33 AM
Al

The control of the procedure wasnt the problem, it was that there was a procedure for an activity that didnt exist.

Laura-2002
26th February 2002, 10:34 AM
Thanks all,

You've clarified a point for me which got lost in the heat of a debate with people who digress and stray from the point....you can see why I got confused.

MG: I was gonna non-conform them for not doing what their procedure says they were doing because their procedure said they were doing something they weren't doing because they hadn't done it yet! Take a breath, bird

They way I see this should be done is that you document an activity and then test the activity and procedure together, and tweak both until they both work. The 'testing' itself is conducted under audit conditions.

I'm gonna go with Eileen, NRG (Fisherboy!) and Lucinda on this.

Keep 'em coming!

energy
26th February 2002, 10:40 AM
Originally posted by M Greenaway
Al

The control of the procedure wasnt the problem, it was that there was a procedure for an activity that didnt exist.

The procedure was published, therefore it's fair game for an n/c!

Write it up, L. Easy, Procedure wasn't followed. Give them 30 days to answer. They will utilize it, modify it, or scrap it. You have done your thing. By the way, where are you working next week? :biglaugh: Just kidding. :ko: :smokin:

Laura-2002
26th February 2002, 10:47 AM
Oh NRG, I love it when you're masterful!

:bigwave: :D

You're right the procedure was published so it's fair game for an n/c.


Big kiss for keeping it simple NRG! MWAH!:ko: :ko: :smokin:

Lau.

Randy
26th February 2002, 10:47 AM
To me it looks like positive evidence of "continual improvement". You're preparing yourself for a change. I see no problem. Then again what do I know? I'm only and auditor myself.:)

energy
26th February 2002, 10:53 AM
Originally posted by Randy
I'm only an auditor myself.:)

After what you said about the Raccoons?

http://16949.com/Forums/showthread.php?s=&postid=26704#post26704

:biglaugh: :smokin:

M Greenaway
26th February 2002, 11:00 AM
Personally I wouldnt accept it as an NC as there is no clause in ISO9001 that you could cite this against !!

This is the kind of trivial audit finding that gives us auditors a bad name.

Just ask yourself what is the effect of this - answer is absolutely nothing !!

Laura-2002
26th February 2002, 11:12 AM
They have documented a procedure for something they may or may not do..'it all depends on whether we do it or not'

Therefore:

1. they are not doing what they said in their procedure. So I suppose that means everyone can document procedures and not bother doing anything b/c Lau won't n/c against it.

2. this means that we should all go round documenting activities we may not do, just in case, then muppet here has to go and audit them and go through all this palaver again and again!

I'm trying to reduce the amount of QPs we have here, not add to them!

MG, when I joined here in Oct 2001 there were approx. 200 QPs for a company with around 150-200 people....hey that's one each! That's far too many for an organisation looking to go with ISO 9001:2000. This is a company feels the need to document everything, I'm trying to come away from that by educating people that reams of paper ain't the Quality way no more.

I am now having to do this the hard way by raising N/Cs.

They wrote a QP, they ain't doing what it says, so they get non-conformed.

I know that our assessor would probably take the same view.



:frust: :frust:

MG, will we ever agree?:p

energy
26th February 2002, 11:27 AM
Originally posted by M Greenaway
Personally I wouldnt accept it as an NC as there is no clause in ISO9001 that you could cite this against !!
This is the kind of trivial audit finding that gives us auditors a bad name.
Just ask yourself what is the effect of this - answer is absolutely nothing !!

ISO 4.2.3 Control of documents
Documents required by the quality management system shall be controlled.
A documented procedure shall be established to define the controls needed
(a) to approve documents for adequacy prior to issue.

Excerpt from our procedure:

PURPOSE
To describe the actions and identify the personnel responsible for review, approval, distribution and obsolete disposition of all Quality Procedures and associated forms/records at My Place.

2.0 SCOPE
This procedure applies to all levels of Quality Policies, Procedures, Work
Instructions, Quality Records and associated forms.

3.0 APPLICABLE FORMS OR REFERENCES

ANSI/ISO/AQS 9001-2000 Section 4.2.3
Quality Procedure QAP-4.2.3-02, Revision Control of Quality Documents
Quality Procedure QAP-LST-4.2.3-01, Controlled Documents Master List
Documented Procedure Template, QAP-FM-4.2.3-05
Quality Form QAP-FM-4.2.3-03, Documentation Release Acknowledgement Sheet

4.0 RESPONSIBILITIES

Person(s) Responsibility
XXXXXXXXXXXXXXXXXXXXXXXX Management and control of all Quality Documents including procedure review, release and control, distribution of all documents (including copies of the Quality Manual), implementation and maintenance of the Document Control System and removal of obsolete documents from use areas.


Based on our procedure that is required by the standard, a procedure is auditable upon release. Sure, the standard doesn’t explain how you control your documents. How about your Tier 2’s? Are you really an Auditor? :bonk: Read Randy’s post! :vfunny: Sorry for the format. The box here is too small to demonstrate by beautiful presentation.
:p :smokin:

Laura-2002
26th February 2002, 11:46 AM
NRG,

Where are you working this week?

thanks for all your help today!

yours,

Angling Anglo! :biglaugh: :biglaugh:

M Greenaway
26th February 2002, 11:48 AM
We arent talking about the control of the document.

Laura didnt say that the document wasnt approved, authorised, or the latest revision.

The NC has nothing to do with Document Control :bonk:

and yes I am an IRCA registered auditor.

Laura-2002
26th February 2002, 11:53 AM
MG:

Pushing everything aside for a minute....you're saying that I cannot non-conform somebody for not doing what it says in their procedure.

I cannot non-conform somebody for not adhering the requirements of the QMS?!?!



Erm........:bonk:

:eek:

Am I missing something here?:lick:

energy
26th February 2002, 11:57 AM
Originally posted by M Greenaway
We arent talking about the control of the document.

Laura didnt say that the document wasnt approved, authorised, or the latest revision.

The NC has nothing to do with Document Control :bonk:

and yes I am an IRCA registered auditor.

Yes,I am talking about releasing a document and citing it because it isn't being used. My response was to AL D suggesting that it be written against ISO 4.2.3. Laura's company didn't mean to release it. Really? Where's the Control? The thread gives varying opinions about whether it is an n/c or not. It was just a suggestion. Geez. An ICRA Registered Auditor? I'm impressed. Really. It's takes dedication and commitment. I understand the reaction to the low hanging fruit, now. Later.:ko: :smokin:

Al Dyer
26th February 2002, 12:02 PM
(a) covers it.

I see no problems writing procedures and instructions for continuous improvements and proposed situations, just cover your butt and don't publish them as reviewed for adequacy and approved.

Laura-2002
26th February 2002, 12:04 PM
I'm off for the day!

Al, NRG, you both got is sussed!

See you all on Thursday.

Angling Anglo!

M Greenaway
26th February 2002, 12:10 PM
Laura

Now you have changed the argument from your original post.

Of course you NC people if they are not doing what it says in their procedure.

What you spoke of in your first post was a new procedure, i.e. a new activity or process planned for introduction at your company which hadnt actually been operated as yet.

The simple question was should you NC them because they are not doing this new activity.

My answer was no, unless you can cite it against a requirement of ISO9001:2000.

To which people muted the clause relating to document control.

To which I answered this has nothing to do with document control.

If however the activity that they are not doing is something like design validation, which is a requirement of ISO9001:2000 then you have them.

If the activity is something unique to the organisation that is not a specific requirement, such as design FMEA then in my opinion it would be unfair and unhelpful and adding no value to the business to cite this as a non-compliance when it is clear that the organisation intends to improve the system, but hasnt put its intent into practice yet.

KenS
26th February 2002, 12:30 PM
I'm very confused. We have procedures for things like Chlorine leaks. Published, not yet used, hopefully never used. They have gone through our approval process and are controlled documents. Since they have never been used are they automatically n/c?

energy
26th February 2002, 02:17 PM
Originally posted by KenS
I'm very confused. We have procedures for things like Chlorine leaks. Published, not yet used, hopefully never used. They have gone through our approval process and are controlled documents. Since they have never been used are they automatically n/c?

Here's the section:
They have four quality procedures and it was suggested that one of the procedures should not be audited because it was written in anticipation of something that is planned to happen and it hasn't happened yet.

1. It has been published. We also have an Emergency Spill Procedure that, hopefully, will never get used. I can audit the people responsible for functions assigned to them in the event of a spill. Do they know their assignments? Do they know the procedure? They cannot tell me that it can't be audited because we wrote it in anticipation of it happening. If I attempt to audit and I'm told that it shouldn't have been released, then it has more to do with Document Control. "Who released it?" "Who authorized it?" "Why was it released and now cannot be audited for whatever reason?" It really seems very simple. You do not float procedures around and expect them to escape scrutiny. In the case of the "chlorine leak" procedure, it may be audited under 6.4 Work Environment. How about I write a procedure for Customer Supplied Product and never use it? C'mon. I may need it someday and must have something to explain how we handle it. 7.5.4. Do I ignore it until I realize that the product at the door is Customer Property? I don't know. Maybe I'm just grumpy. Maybe I'm exhausted from muting clauses?:vfunny: :ko: :smokin:

M Greenaway
26th February 2002, 04:15 PM
As a final shot.

I think auditors should be more concerned with auditing actual activites rather than trawling through procedures line by line, and I think ISO9001:2000 supports this - time will tell :p

Randy
26th February 2002, 04:42 PM
When I had the flu earlier this month I went IRC-----AAA a few times:biglaugh:

db
26th February 2002, 04:57 PM
Okay, now to make enemies

For those of you who say it is non conforming because they are not doing what they say:

First, “Where is the shall?” Show me, in the standard where it says: “The organization shall do what they say.”

Let’s change the parameters just a bit to illustrate my point. There is a procedure for handling nonconforming product. Since the procedure was incorporated two years ago, there have been no incidents on nonconforming product. I guess we need to intentionally mess up some product, so we can sow evidence that “we did what we say we do”. Or what about corrective actions, or the management of an area taking responsibility for problems found during an internal audit, when no problems are found!
:eek:
Give me a break! (sorry for the harsh language) Martin is correct. We cannot implement a procedure that was not written, and we can’t write a procedure until we do what the procedure says we will do. Get real! I can not justify ANY nonconformance which does not result in some adverse effect on the QMS, the product or customer satisfaction. In Laura’s original statement she said:

Quote:
-----------------------
“it was written in anticipation of something that is planned to happen and it hasn't happened yet.”
----------------------

The organization is using their head and preparing in advance. You are going to write a nonconformance for planning and preparation….are you crazy!!!! As part of the product planning process you write a work instruction for final inspection. Are you going to write a nonconformance if the product hasn’t made its way through the process yet? I thinks the roadkill you had for lunch gave you mental illness.

This does not even qualify for an observation. I would note that the procedure is not yet implemented in the audit report, and check it again next audit. If it is still not implemented, I would then suggest they look at it for relevance.

energy
26th February 2002, 05:24 PM
Originally posted by db
Okay, now to make enemies


No enemies here. Just dissenters. Foregoing all the spewing about roadkill and other inebriated induced comments, I can audit any procedure that is written. Whether it has been implemented or not. I have a record that shows me that the procedure exists. I'm also auditing knowledge of the procedure. Do the persons responsible for the activities know what they will do when the procedure is used? "What are your responsibilities in this procedure?". I already know because the procedure says who will do what. If there are no records, fine and dandy. If the answer to my inquiries is "Hey, we don't even use the procedure" or "it's for future use", I ask again. The procedure says you will do this. Do you know that? The answer better be "yes". The next question may be, what else would be your responsibility? Don't know? Then it's a case of lack of training in an Authorized/Approved Released Procedure. That's a n/c. Not even an observation. Pure and simple. So rave on. It's just your opinion, just like mine. Hasn't changed my mind at all. And, Relax!:bonk: :ko: :smokin:

db
26th February 2002, 09:12 PM
I would never say anything just to make enemies. And yes, I have been known to take "an alternative view" just to get folks brain juices flowing. If everyone agreed with me life would be a bit monotonous. I would much rather you disagree with me in public, than disagree with me quietly. No one will learn if we keep to our selves. That is one important lesson that the Master Marc has taught us well!
:agree:

Even though you are wrong! :vfunny:

db
26th February 2002, 09:35 PM
Okay, my last work on the subject (unless another post compels me to respond) Sorry, but it is a long post

Hey energy, let’s see if I understand you. If I do, what you are saying is that if there is a procedure, and for what ever reason it is not being followed, it is still required that those individuals implementing the procedure should know it.

Earlier, I gave a scenario of a work instruction for final inspection of a new product. The work instruction was developed during the planning stages. The product is just now beginning to be produced. If I am following your reasoning, you are saying the final inspectors need to know the procedure prior to performing it. Therefore, it is fair game to interrogate (sorry…interview) the inspectors on the new work instruction.

If they do not know the work instruction, then you are basing your N/C on their inability to perform the work instruction. Okay, I can see that being an issue in real life, regardless of the QMS. It would indicate perhaps a lack of training. I could easily support a nonconformance in that instance. But writing a nonconformance just because the procedure, work instruction, etc. is not being performed could lead to disaster.

The thing that scares me is we want companies to develop the processes, procedures, work instructions, etc, during quality planning, yet there are those that say if they do develop these in advance, we will penalize them for planning. Most routers, travelers, BOMs, etc. are developed prior to the work actually starting. In many cases these are work instructions. Are we to write N/Cs on these as well? “Well gee, Ms Production Manager, I see you have seven travelers on your board for work scheduled to start this week that you haven’t started on. Well those are all nonconformances. You say your are working on these, but they’re in the queue and not being working on. Since more that three minors equal a major, and you have seven separate instances, they I’ll have to write you up for a major.” Unrealistic, of course. Even the most egotistical auditor would not do that, but how is that different from Laura’s original post?

An auditor must be careful here; internal, or external. If the auditee has the slightest inkling that they are being penalized for advanced planning, you might just a well quit auditing. If I take the necessary advanced planning steps to ensure the product conforms and an auditor says I can’t have a procedure prior to the actual work, anything else the auditor does, says, or writes will have no value to me! I personally would rip up the nonconformance and say never bother me again.

JodiB
27th February 2002, 12:18 AM
Well said Dave:)

M Greenaway
27th February 2002, 07:15 AM
So energy would raise a non-conformance for training that hasnt been given on an activity that hasnt even started yet, or that people arent working to a procedure that hasnt been implemented yet ?

Dear god help us all !!

energy
27th February 2002, 07:39 AM
Originally posted by Lucinda
Oh god I am so in love. (energy, this is where you make reference to candles and massages I think:vfunny: )......

For you sweetie, we'll leave the candles out. There's me!:eek:
We'll pick this up when I get to work. Talk about smoke and mirrors. But, then I'm dealing with "Crowned" auditors.

M Greenaway
27th February 2002, 08:51 AM
No not 'crowned'.

Just well trained, experienced and professionally recognised.

SteelMaiden
27th February 2002, 09:17 AM
OK kids, let's take a deep breath.

We have shown that not all procedures get used (often) hopefully, thereby proving the fact that you can have procedures that only get used when certain things happen.

There is also a little thing called quality planning. Get all of your ducks in a row before trying to float 'em. The procedure is there, it is implemented to provide guidance when the new process comes on-line. The only way I can see that it would be a noncon is if it is still there 10 years from now, and the process is no closer to being started than it is. Part of the planning process should be to set up a time frame for implementation of the process, no?

As long as the procedure does not adversely affect the quality system, aligns with the quality policy and objectives (one of which should probably be to implement this new process), there is no way to issue a noncon without looking like a nit-picker. We are a start-up div., and if I got cited for every procedure that we wrote before we started a process, I'd be rubbing my raw little @$$ for the next 2 years.:eek: :biglaugh:

Remember, auditing is to assess the compliance to the standard, not to assess the non-compliance. 'nuff said, y'all have a good day, I have a couple of fires to fight myself!:ko:

energy
27th February 2002, 09:52 AM
M,

Oh, you’re recognized all right. No doubt about it. Back to the subject. We have a few procedures that are in the draft stages. They are reviewed, modified and with a major consensus from our Steering Committee, eventually approved and released. Published, if you like that term. There is a large “Draft Copy” imbedded on the cover, using Word Art. That remains on it until officially released. The effectivity date, remember that?, says TBD. (To be determined). That’s a good time to practice auditing it. Let’s not lose sight of the fact that a lot of us are in the start up mode in respect to ISO. Not the polished Auditors some claim to be. The players get to critique it to see if it says what we do. Remember that? db’s rendition of the Final Inspector scenario is flawed because the procedure is written to reflect what they already know. Do what we say we do. Tired of it yet? Now, when authorized for release, the Word Art disappears and an effectivity date inserted. With me so far? That effectivity date is the day that the procedure is goes into effect, thus it is ready for auditing. The hand wringing about the company being pro-active because it releases procedures not ready for audit just flies in the face of the intent of real document control. Here, we go a step farther. An “Authorized/Approved” document is distributed to all personnel that has the procedure, revision, effectivity date and the person’s name on it. In part it says;
I acknowledge receipt of all the procedures/documents as shown above. I have read and understand all the procedures/documents listed. Furthermore, I an aware of the procedures/documents pertinent to this position of this department should be used as a reference on a regular basis. Please return the signed and dated XXXXXXXXXXXSheet to the Quality Assurance Department. Due Date: XXXXXX. This becomes a record. Why go through all this? Because an Auditor, one with more credentials and time in service than you, asked, “How do you know they read and understood the Procedure released or revised?” Granted, some procedures involve some training due to ISO requirements that they/we had to create in order to be in compliance with the standard. In those cases, we have training records.

So Laura, if it’s released, audit it. When it’s all said and done, it’s your company and you set the policy regarding Document releases. Incidentally, the place to address this would be in your Document Control Procedure. Has that been released? Or, is it one of those released documents that nobody has to understand or follow, yet? Hey, we may have a created a new kind of procedure. Just think. It may have started her in the Cove and we all had a hand in it. I want to be in the credits.
:vfunny: :ko: :smokin:

M Greenaway
27th February 2002, 10:25 AM
Energy

If you didnt have a document control procedure that would be directly in contravention of ISO9001:2000, hence an NC would be appropriate.

Laura's case was not directly in contravention of ISO9001:2000.

Your procedure talks of an approval process - what if Laura's procedure has gone through this process properly, what would you cite your NC against. It isnt document control because the approval has been conducted correctly.

As for flying in the face of real document control, all document control is concerned with is ensuring that the correct revision of appropriate documents are avaialble at the point of use. If an activity isnt in operation how can you determine this, and therefore write up an NC against document control.

This issue is not concerned with document control.

The rest of your post regards training, again I wouldnt expect someone to be trained in something they dont do, hence again no NC is required.

energy
27th February 2002, 10:49 AM
M,

This was my first post. Laura,

I assume that this is Internal Auditing. We have the same thing. Procedures have been written referencing other procedures and documents that are in the draft stage. Audit them, write them up and practice your Corrective Action Procedure. It's all practice for the real thing. I get written up for using documentation that we are in the process of making "official". I like it because it means that our auditors know the difference. Nothing personal. Go for it, Fishergirl!
------------------------------------------------------------------------------
Practice your Corrective Action Procedure. Issue them a CAR and be prepared to get it shoved back at you with an explanation why it is not a n/c. There is no better way to learn. To intimidate an Auditor because they want to Audit a released Procedure isn't the right way to prepare for External Audits. YOU would write up your findings, ignore attempts at pre-emptive interpretations by the auditee and the company has the right to refute them. Maybe not convince you, but that's how it's done. I have audit findings in front of me that will never find their way to Mgt Review because they are wrong. I was emphasizing the method you use to convey your concerns. But, that was before we got into other interpretations. The document control thing was a suggestion and, as far as I'm concerned, a valid way to enforce the concept that people need to know the procedure has been released and that those responsible have to be aware of their responsibilties. Why can't you audit their knowledge of the procedure content? I still don't get it. True, I haven't used yet. But, it's out there and people should be aware of it's contents. One way to find out is to ask. Guide me, oh wise one!


:agree: :ko: :smokin:

M Greenaway
27th February 2002, 12:30 PM
I understand what you are saying about raising any audit concern (any concern) formally in the system so that its on the record, and any action or non-action is also on the record and there for posterity.

My concern would be that a flood of minor findings would be documented and processed in this way, which may detract from the real issues of compliance with ISO9001:2000, and the effectiveness of the quality management system - which is the purpose of the internal audit programme.

Even if you wanted to audit a 'proposed' procedure how would the auditee be able to demonstrate objectively that the procedure was implemented - they clearly would not, hence your audit is a non-starter.

You might ask the person what they would do in a theoretical situation, and assess their answer against the procedure, and you might find that they dont know the requirements of the procedure properly. This may tend you towards raising an NC against Training - which may be justified bearing in mind that auditors cannot spend endless time on an audit. However a good (in my opinion) auditor before he raises his NC will consider the effect of what he has seen. I.e. not just auditing compliance but considering the effectiveness.

You must agree that somone not fully understanding a procedure that defines a process that is not currently operational will have no effect on either the quality of the product or service that the company delivers.

Contingency plans however would be a different kettle of fish.....

energy
27th February 2002, 12:38 PM
Originally posted by M Greenaway
You must agree that somone not fully understanding a procedure that defines a process that is not currently operational will have no effect on either the quality of the product or service that the company delivers.
Contingency plans however would be a different kettle of fish.....

Absolutely:agree: But, a lot of stuff auditors write up, even External ones, don't meet the criteria you mention above. Not you, of course!:biglaugh: :ko: :smokin:

M Greenaway
27th February 2002, 12:47 PM
No not me !

Thanks for the debate energy - we sailed close to the wind but maintained a healthy debate.

Right whats next..............oh yeah I better go do some work :vfunny:

Al Dyer
27th February 2002, 12:58 PM
Could we be forgetting the theory of root cause?

Were talking about hypotheticals and maybees and whether "A" would do "B".

Who cares, A piece of documentation made it through the approval and publishing process without being verified. If somebody came to me, as a document coordinator, and asked that a document be accepted and published I would ask why.

If that document served no purpose to advance the quality system I would deny the document. If they say it might be implemented I would say submit it at the proper time.

Many of us have documents, procedures, insructions, forms etc... that we like and would want to see but we keep them on our hard drive until the right moment. And that might be after the continuous improvement project is completed, or the new system is in place.

We all have a procedure/document or two that might be hypothetical, we call them "Contingency Plans"!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

Laura-2002
28th February 2002, 03:29 AM
Hi Folks,

And thanks for all your input.

Just thought I'd clarify a few things by being a bit more specific.

This area has four quality procedures, one of which was published (before I came to work here in Oct 2001) prior to implementation. The procedure was concerning a document that should be completed by a working group prior to a project being undertaken.

My issue was that this procedure was written because it was 'intended' that this document completion exercise be implemented when top top bods had signed it off.

Needless to say, it was thought by whoever, that 'we'll publish the procedure and then get the top top bods to approve 'the activity' later.'

Then along comes muppet here to conduct an audit and find that a quality procedure has been published for an activity that is not being implemented or approved. They are still doing projects, so why aren't they having this document completed?!?!?

Can I just say that they are now thinking of scrapping this activity b/c it is just 'too hard' to get top top bods to pay attention.

What is the point of that? They obviously felt that they needed this activity before, why not now? I will be mentioning this in my report.

Anyways, the point is, the procedure was approved by the person resp. for it, as allocated by a Director in accordance with our procedures. This clearly shows that there are issues here, ones which I had already identified when I first came here, and now have the evidence to back up!

The outcome of all this, is that the auditees have gone away with their procedures toreview them, so MG I think this is a good thing. They are now looking at what they are doing, what they say they are doing and looking at ways of doing things better. So, as I told them an n/c would need to be raised they have actually got their fingers out of their :ca: and are doing something.

What I'm saying is, their procedure was not massively important in the first place. It would have improved operations of it had been implemented but the interest was not there. I suspect it was published in order to say 'well it's there, we should be doing it.' As it turns out they've decided to scrap it altogether.

My approach is to do compliance audits with the aim of recommending improvements. But I have to say that things like this should be clarified in any business.

I think this situation has come out well, so far. I certainly got their attention.

I appreciate your input guys.