Posts: 2790
From:West Chester, OH, USA
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posted 31 July 1998 08:19 AM               

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Yeah, Don. I really posted the list originally just to get some thought going and with consideration to my experiences. For a number of years now I have made my 'living' interpreting specifications - which is how I got into ISO and QS to begin with. It never ceases to amaze my how auditors (not to mention companies) interpret specs and documents in general.

In my first ISO audit the auditor wrote the company up because changes to the quality manual (in one instance) "...are not easy to see..." We had a database where all changes were item by item recorded. When I first got involved with the company in helping them in their effort, their quality manual sucked. We radically revised the manual and in the database we simply put the following statement, "The changes to the manual are extreme and thorough. To tell what each change was, please compare the two documents." We did this because it really seemed stupid to write up 1000+ plus changes in a database. I mean, hell - the whole manual changed. Rather than being smart and obsoleting the document and releasing an entirely new 'series', we did what we did. Note that *every* other document change was detailed in the database.

I said "Where does it say it has to be easy?" I was told it was implied and the auditor wrote the company up with a minor (the only finding during the audit). This is where I realized auditors can be completely stupid with consideration to interpretation of the spec. I thought, previously, that only DCAS were bitches.

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Posts: 551
From:South Central Massachusetts
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posted 31 July 1998 01:44 PM               

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Christopher....that 'yes' is what gets you in trouble...perhaps a more appropriate answer would have been, "yes....that is one example I've seen" or the like, implying that they need to look at what is appropriate for them as evidence. if someone answered as you did, and I was not "spec friendly" I would understand that a signature was what the auditor wanted to see.

Yet another misconception....the biggest of all .....regards communication: the japanese say that the biggest misconception about communication is that it has been achieved.

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Posts: 109
From:Auburn, NY
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posted 31 July 1998 04:05 PM               

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Barbara, Barbara, Barbara yes was paraphrased to avoid a long dissertation. My point was that there are two sides to every story, and that there may be more good auditor out there than you care to believe. Kind of like consultants.....

ChrisTIAN

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posted 31 July 1998 05:30 PM               

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Christian...About your purchasing comments. Where in the standard does it say I have to provide objective evidence of approvals. It just says I have to review and approve them prior to release. I was taught that it was an auditor's job to find the objective evidence. I know that it would be much easier for an auditor if there were signatures on everything but how could this be a nonconformance? Doesn't this support Marc point about interperting the standard and not reading things into it so it fits a particular view of how things should be done?

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Posts: 551
From:South Central Massachusetts
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posted 31 July 1998 08:07 PM               

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christian, christian, christian.....despite popular belief I do think there are many many good auditors out there...and consultants as well. BUT this board was getting very quiet and needed some "waking up"...so i hit a soft spot....now lets keep a dialoge going.

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Posts: 551
From:South Central Massachusetts
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posted 31 July 1998 08:19 PM               

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Michael, evidence can be stated simply in the procedure for instance..."when the purchaser has entered the data as prompted on the screen, he/she reviews the entry for accuracy, then keys to enter the posting." the entered data is the evidence....

Same goes for contract review of verbal orders....' order entry records the information on the screen as provided by the customer, and requests any additional information as prompted. Then reads back to verify, resolves any descrepancies, then enters the order.

Key to the success of both is the content of the form on the screen.

Simple enough, eh?

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Posts: 109
From:Auburn, NY
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posted 03 August 1998 08:24 AM               

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Michael, I never said that there HAD to be an actual signature on a PO to constitute approval. However this is an acceptable method, that is easy to verify and implement, especially if the company does not use a computer system. A computer system with limited access is acceptable. In the example I provided, the purchasing system WAS NOT computerized.

I must confess that I encourage my own companies personell to use signature and dates whenever possible on hard copies. It is a practice that has served me and other well throughout their career. Those who work in heavily regulated industry (medical device) would agree. Unfortunatly, a handshake and a smile do not constitute approval anymore.

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Posts: 485
From:Tullahoma, TN
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posted 03 August 1997 04:18 PM               

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My apologies for not responding to this thread sooner. I have a client that is preparing for a State inspection and the last couple of days have been hectic. Christian, ãapprovedä does not mean a signature is required, nor does the standard require ãsignaturesä unless you are a ãregulatedä industry. The companyâs procedures shall state when review and approval is accomplished. No more, no less. Of course, objective evidence is required, but this evidence should be the companyâs, not the assessors. As far as continuous improvement is concerned, that is a different story. When a company decides to adopt a quality standard as their business core principle, the company decides which practices are best for them, with the primary goal being ãto stay in business.ä Customer satisfaction, making money, etc. Barb, preconceptions are not to be allowed or to be tolerated. I agree. The assessors job is to obtain objective evidence of ãcompliance or noncompliance.ä No more, no less. I have stated earlier that when an assessor ãsuggestsä things required for compliance, this is a no-no. I also agree that some (not all, by no means) consultants may try to mold a companyâs policies and procedures to their (the consultant's) mold, not the standards. Things adopted by the company may not add value, but an assessors job is not to determine this. Again, ãcompliance or noncomplianceä is the issue for them. Barb, a company with 5 or 10 employees do not need reams of paperwork or unnecessary documents to comply (see misconceptions above). As a matter of fact, other than the costs, small companies are the easiest to register. That is the magic and magical purpose of ISO 9000. It IS that flexible. There is much benefit to using ISO 9000 to improve a business operations. This is determined by the company, and company only. The purpose of the list was to highlight what those who do not know try to know. By the way Marc, DCAS was my most driving force to be in this business (doing things right, not by the so-called rules). I have a good story I will forward at a later time.

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