posted 08 May 2000 12:34 PM            

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Originally posted by Marc Smith:

If you have read any of my rants, this is what I tell people. Internal audits should focus on function systems - not compliance to a spec like ISO9001. Let your management rep ensure your 'master' systems are compliance.

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Nice if you have the resources, but at our company, I as the MR, schedule all the auditing for the entire company, follow up on them, do effectiveness audits, and all documentation of audits, management review, as well as validate that we cover all aspects of the quality system. We do audit to the process / procedure. I feel that if I have verified that we cover all aspects of the elements through our procedures / work instructions, that I AM auditing the entire system - in one swoop. So far, my registrar has been acceptable to this.

I do like the suggestion of others to audit following the project through our system, wondering how far in the future it'll be til I'll have a chance to try something new. We are so busy developing processes and trying to shave the un-value-added items, that there is little time to try to be creative!

Oh, in response to not thinking of Caymen as a consultant, guess I'm guilty also. Sorry, just got in the habit of seeking information without putting thought to how this forum exists!. Sorry........

posted 08 May 2000 12:49 PM               

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...Nice if you have the resources....

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posted 08 May 2000 01:00 PM            

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Originally posted by Marc Smith:

Please explain.

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As a one person QA department (in a company which fluctuates from 70-100) personnel, I find it difficult to cover all the bases adequately, let alone do a superb job.... I read your reply as sounding like there was "department" involvement as auditors (my husband's company audits their own department and is responsible for compliance by department) My company hasn't got that far yet, the previous MR did EVERYTHING and never included the 'working' people in development...they somehow got accredited, but I sure don't know how, cuz they don't do all the things they are supposed to do!! But we're working on it!!!

Editor's note: Edited for QUOTE formatting, not for content.

posted 08 May 2000 02:22 PM               

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As a one person QA department (in a company which fluctuates from 70-100) personnel, I find it difficult to cover all the bases adequately...

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Your company has to decide what to audit. You have to audit all 'elements' once a year.

0. Review past audits - internal and external. Identify problem areas.

1. Start at the top level - do you have procedures which address each 'element'? If not STOP. Note that this should not be an issue if you are already registered unless you allow changes to your 'master' systems (typically your level 2's) by someone unqualified (one who does not know and understand the specs you must meet and the implications of changes to the procedures. For most companies compliance should not be an issue.

2. Take your matrix which says which department(s) have to comply with which elements. Choose a sample. For example, take Quality Records. Almost every functional group will have quality records and thus have to comply to the element requirement. You don't have to audit every department for quality records - let's say we choose purchasing. Verify POs and other departmental quality records are controlled per the departmental procedure(s) and that if procedures are local that they meet level 2 requirements. You might want to choose a second sample - say receiving or design.

The idea of internal audits is to sample your systems - it is not to audit every procedure and every work instruction in every department you have, although the QS people sure like that approach.

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...I read your reply as sounding like there was "department" involvement as auditors...

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...my husband's company audits their own department and is responsible for compliance by department...

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the previous MR did EVERYTHING and never included the 'working' people in development...they somehow got accredited, but I sure don't know how, cuz they don't do all the things they are supposed to do!!

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1. Most companies I have worked with had internal systems which met most of the requirements. Many do not, for example, have supporting documented procedures. However, as an example, most companies do have a way of identifying and segregating nonconforming product. So you document it. People aren't doing anything different - the only difference is there is a guiding document where there was none before. In this case the only thing you do is make people aware of the document covering what they are already doing. While it is not always this 'clean' (there are typically some adjustments) often there is no reason to involve folks in the development.

Don't get me wrong - I believe people should be involved in the process as much as possible. Often, however, the reality is they aren't involved much. Some complain they have their 'real' jobs to do (the nerve! )

It is the second issue that scares me, however. You say: "...cuz they don't do all the things they are supposed to do!!..." which tells me either you are wrong or your registrar was superficial. In any case, the question becomes is this a discipline issue or a training issue?

No matter - the topic is internal auditing. Whether you do everything your self or recruit internal auditors to assist, the total hours necessary to do the job will not change. They will depend upon the extent to which you plan your internal audits. Don't forget "...scheduled on the basis of the status and importance of the activity to be audited...".

"...internal quality audits to verify whether quality activities and related results comply with planned arrangements..." Are people doing what their procedures say?

"...and to determine the effectiveness of the quality system..." A management Rep function.

From the 2000 version:

"...8.2.2 Internal audit

The organization shall conduct periodic internal audits to determine whether the quality management system:

(a) conforms to the requirements of this International Standard;

(b) has been effectively implemented and maintained. The organization shall plan the audit program taking into consideration the status and importance of the activities and areas to be audited as well as the results of previous audits. The audit scope, frequency and methodologies shall be defined. Audits shall be conducted by personnel other than those who performed the activity being audited.

A documented procedure shall include the responsibilities and requirements for conducting audits, ensuring their independence, recording results and reporting to management.

Management shall take timely corrective action on deficiencies found during the audit.

posted 09 May 2000 01:32 PM               

And you could always find a company nearby that would like to team up.