Translating Audit Check List to Guidelines - Paperwork Reductions

M

M Greenaway

#11
You are right Edith that the decision to control documents based on actual contents and use is potentially difficult to manage as someone has to assess each document. Like you say it is far easier to say 'control everything', but this does lead to the huge beurocracy that has blighted ISO9000 for years.

It might be easier to categorise what you control, such as quality manuals, procedure and work instructions, and what you dont control, such as forms, guidelines etc.

To my mind a guideline sounds like a procedure in another guise - hence I would make the blanket inclusion of guidelines in my controlled documents.

The question might be asked - why have a guideline if you have a procedure ?
 
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J

JodiB

#13
Guidelines

Well, in my case, the "guidelines" were some instructions (for which we had no formal procedure) mixed in with my personal suggestions, comments, helpful hints. In otherwords, alot of my own opinions based on what I thought would be the best way for them to do what I wanted them to do.

Eventually they will be formalized into procedures and most of my b.s. will be taken out.

In the meantime, they are simply "guides".
 
L

Laura - 2003

#14
Isn't it about definition?

JMHO

The way I've seen it work b4 is in a pyramid diagram. Bearing in mind the organisation in question is accredited to 1994.

At the top you have your quality policy, (mission statement and the flag of the quality system)

The top section of the pyramid was the Quality manual written specifically to address each clause of the std.

The next section is Quality Procedures (QP), which documents in a fixed format what we do and outlines the expected output in the form of an objective...This is what the assessor would audit us against.

The section below this is the local work instructions of guidelines. These stated how we did something and was directly referred to by the QPS.

For example: for a Data Input dept, the QP would state in a flow chart formt what happens to a policy when it is input onto the system. This is useful information for anyone who needs to know who is responsible for the input of the policy and what is done to ensure a policy is input.

As a QP is accessible to everyone, everyone does not need to know the ins and outs of this particular dogs
:ca: so the LWIs aka guidelines are there to tell the user, the eprson who actually does the job, that they need to press F1 to access a particular screen etc...

The QP documents enough to be audited (Including resp and auth, qu recs and related docs) and so the assessor does not feel the need to audit the guidelines because as long as what is stated in the QP happens and the quality of the work (In this case the policy is entered onto the system accurately and the paperwork filed accordingly) is not affected then why should he?

BTW: The LWIs are referred to by the QP saying something like: Data INput operator inputs appropriate information onto the database as specified by the LWIS.

This is why the LWIs need to be controlled b/c if certain things like specified criteria is changed as the result of verification and validation activities then everyone needs to know this and have this change made to their copy of LWIS so that they always have an up to date reference guide....b/c let's face it LWIS are not always used daily b/c we all know how to do our jobs well.......allegedly!

At the bottom of teh pyramid are Standard letters, forms and docs...but that's another story!

Hope I haven't bored you all too much!
:lick: :bigwave: :rolleyes:

Lau:)
 

Raffy

Quite Involved in Discussions
#15
Hi M. Greenaway,
Originally quoted by M. Greenaway:
"By creating 'guidelines' you might well be merely re-creating existing systems under a new title. I have issued checklists to be used in audits but have always said that they are compiled and issued by myself for that specific audit only, hence have no need to be a controlled form (this is a bit tongue in cheek, but so far so good). "
You could alternatively issue your guidelines in your procedure, if they are general enough.

You're right, I would want to re-create the existing system under the same title. and I will alternatively issue my guideline in my procedure (they are in general):agree:

Thank you for the inputs and for everybody who help me to enligthen my mind regarding this issue... :)

Best regards,
Raffy
 
A

Al Dyer

#16
Once you fill out the form it becomes a record. No need for revisions or anything else, just store it per your record retention procedure.
 
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