Seeking: Element 9 Process Control procedure example


Andy Bassett

I seem to always end up having a problem with this particular element becuase usually by the time i have finished documenting a companies procedures i have already defined how they want to control the Design, Manufacture and Inspection points. If i really wanted to let an auditor know how we satisfy this element i would have to repeat what has already been written.

Recently an auditor advised me to simply write a index showing where the relevenat sections that satisfy element 9 can be found in the handbook.

Now this would be a quick and easy thing to do, but i fight tooth and nail to avoid putting ANYTHING in the Handbook that smells of Blah Blah.

Can anybody advise me, send me a copy of a element 9 procedure or point me in the direction of where i could find one.
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Kevin Mader

One of THE Original Covers!
Staff member

I have always been a proponent for creating the Quality Program around the existing Quality System. I prefer it this way because it makes for easier maintenance for both internal auditing and document control. By doing this, I have 6 level 2 documents covering all the elements. Creating specific documents for each element creates redundancy in a program (IMHO). Perhaps this is the situation you find yourself in. If so, you may want to consider fewer documents as an option.

As far as creating a book to point an auditor in a direction, I have to agree with you there. Just not worth the effort. It has also been my experience that most external auditors require you to fill out a questionaire for them pointing them in the direction (part of the suitability audit, desk study). I would, and have, used this questionaire to help guide a registrar through an audit.

I have found Process Control to be one of the most under utilized aspects of ISO, perhaps since many organizations are so Inspection dependant. Most folks go into great detail on how the inspect things, not so much on how they try to build Quality into product. Unfortunate. I commonly receive Quality Manuals from potential suppliers and most of them refer to obsolete inspection MIL specs.. To quote Deming: "Eliminate dependence on mass inspection for quality control; instead, depend on process control through statistical techniques." Best said by him I think.



Back to the group....

p.s. Marc, I had to try out your cool bells and whistles (icons).

Andy Bassett

'I have 6 level 2 documents covering all the elements'

At the risk of making a fool of myself what do you mean by this?, do you mean that your second level of documentation explains exactly how you satisfy the various sections of ISO 9000, and if so does anybody in your company read it or is this mainly for the auditors.

This is a real bone of intention for me. I have a theorey that company absorption or uptake of a Quality system decreases exponentially with the thickness of the Handbook, and i was last week successful in getting a company certified with just 6 Main Processes, 11 Policy Guidelines and 5 work Instructions (22 pages in all, OK theres only 10 people in the company). Unfortunately it was a pain with the auditor as he couldnt find what he wanted and it was hard to prove that we satisfied the Standard. I am now seriously considering doing something like a top level of documentation that virtually nobody in the company reads except the auditor. Is this what you mean with your level 2 documentation?

Unfortunately this goes against the grain a little as i always try to sell ISO to companies on the basis that with a little effort and careful implementation it can be made to contain items that are useful to the company.

I once watched one group of consultants put 11 members of a Management Team to sleep with a 103 page handbook (without the Procedures etc). It was hard work to persuade them that ISO has its plus points after this.

Lastly your points about moving the emphasis from Insepction to more Proactive activites is 100% correct, i still find it hard to beleive that in the year 1999 it is difficult to persuade companies to carryout supplier audits etc.

Back to the main point quickly. Can you offer me any suggestions as to what should appear in a Procedure for element 9 Process Control, my feeling is that even if the company is relatively proactive, these points will be covered in other elements ie 6 Purchasing etc.

Kevin Mader

One of THE Original Covers!
Staff member

Essentially what I do is to look at the various processes that make up an organization. Each organization is different in how things are done, perhaps most influenced by the size of the organization. For my organization, I have identified 6 main processes, but there can be as many as you feel best represent an organizations business (I also recommend Flow Charts as Lassitude suggests). For each, I create a document to explain how things are done in this process. I have found that it is easier for folks within the system to identify with processes they see every day rather than trying to relate to a specific document written for 4.9. Yes, I have to agree the folks who read the Program tend to be mostly auditors, but I have seen a higher level of interest in the SOPs as they are written in this fashion.

Now is it more effective to monitor 6 or 20 SOPs? That can only be answered by the organization. For us, 6 does the trick for now.

Also, folks creating an SOP for each element of the ISO standard tend to get boxed into a corner. By this I mean that for each item (defficiancy) uncovered after the original creation, often results in the creation of another document to satisfy the need. Also, as the standard changes, as it will undergo a large format change with the year 2000 edition, the look of the program will look outdated. There isn't anything wrong with that, just leads to suspicion of an inactive system. For me, I think it is easier to create a program to reflect an organization on the simplest terms.

My SOP 3 for Material Management and Manufacturing Processes covers 4.3, 4.4, 4.6, 4.7, 4.8, 4.9, 4.10, 4.11, 4.12, 4.15, and 4.20.

My SOP 1 for Conception and Design Control covers 4.2, 4.3, 4.4, 4.8, and 4.10.

While element headers are repeated in some cases, this does not mean that redundacy prevails. For example, is discussed as part of SOP 3 but not in SOP 1. But 4.10.1 is found in both (as it is a general statement). Certain points of different elements are discussed as they fit within our system, so they can be found in various SOPs. The 'pointer' of where items are discussed is the Quality Manual, which referrences the correct SOP. Fairly straight forward, and has never been a problem in the past.




I think you're going way beyond the pale. I'd have to see a diagram of the documentation structure, however you've lost me. The only documents a person should be responsible for is/are those which affect them in their work. There should be no need for someone to have to wade through a 103 page manual.

As far as pointing out what document satisfies what, I use a matrix and have for years.
Back to the main point quickly. Can you offer me any suggestions as to what should appear in a Procedure for element 9 Process Control, my feeling is that even if the company is relatively proactive, these points will be covered in other elements ie 6 Purchasing etc.
I suggest you get some of the procedures here at the Cove and review them. So far I have not worked with two companies with similar precedures for section 9. When I work with companies in implementation I use one or more flow charts to 'describe' the major processes. But then I do no text documentation any more. The level 2's are a series of linked flow charts. A compliance matrix is made for implementation and for the auditor to show what flow chart(s) addresses what element/section of ISO/QS.

Again, if you take a good look through this site you will find example procedures. If you do a search in the forum as well you should find a link to systems flow charts (all linked up and everything).

[This message has been edited by Lassitude (edited 29 June 1999).]

Andy Bassett


Thnaks for that info, i suspect that i am following the same line, in my most recent organisation i identied just 6 main processes and converted them into flowcharts, and like your system these 6 processes cover most of the ISO 9000 Elements.

What i begrudge is having to produce any other documentation to point the auditor in the direction of the flowcharts, but i guess i am just being difficult.

You mention a handbook for pointing to the Main Processes.
1. Is the Handbook written as per the ISO Norm ie element by element.
2. Who do you expect to read and understand the contents in the handbook.
3. Do you try to keep this away from the workforce.?


Kevin Mader

One of THE Original Covers!
Staff member

I am glad to hear that you have taken the approach of creating according to main processes. I recommend this to any organization about to create the Quality Program.

On to your questions:

You mention a handbook for pointing to the Main Processes.
1. Is the Handbook written as per the ISO Norm ie element by element.
2. Who do you expect to read and understand the contents in the handbook.
3. Do you try to keep this away from the workforce.?

The handbook you refer to is the Quality Manual itself. It addresses element by element, point by point, all the requirements. I believe that most will agree that a QM is a quick rip off of the standard stating pretty much that your company 'will' to this and that, just not how, who or when. Of course these are detailed in the governing SOPs which are referenced in the QM. For each element, I explain the 'we will do this and that and it is detailed in the Level 2 procedures.' I then go on to include at the very end of the 'we wills' a section that references by name each SOP that represents a point/element. Essentially, this is the matrix other folks use to help readers/auditors find their way through the program. It has been fairly effective I think.

As a matter of fact, I want everyone in senior level, middle level, and fist level management to read the QM and supporting SOPs. Fact is, some read, some don't, most skim. While I have seen many QMs that reiterate the standard, I have taken the effort to create something I consider more "reader friendly". Perhaps I have had some better success, perhaps just my ego hoping so. I just wanted something 'home cooked' as opposed to getting canned products. I once received 3 QMs from different organizations from different states in one week where the only difference was the name of the company (ie XYZ believes in commitment to Quality blah, blah, blah). Indicates to me that management believes Quality can be purchased in a bottle (Where is that missing magic wand anyway Marc?).

In order to broaden the opportunity to disseminate the Quality Program, I have placed the QM on the server in our organization. Whenever and where-ever a question comes up from someone wanting to know, it is generally pretty easy to find a vacant computer to bring up the QM, SOPs or anyother controlled document in the system. I find this to be quite convenient.

I hope this helps a bit. So back to the group....



Let me bounce this statement off of all of you and see where it lands. In our Quality Manual we referenced in 4.9 the procedures and work instructions as being the items that control processes. In our procedure manual or in some cases our work instruction manual we have flow charts showing the process. We are an electrical distributor so we only have id'd three main processes. I think this method is effective and adds value in that any employee can check our work instructions or procedure and see the whole process and their part in it. Our outside auditor seemed to think we went far enough, do you?

Russ Jackson

John, someone may jump on this suggestion, but you could exempt yourself from dealing with Process Control by stating that it does not apply in your business. As I understand a distributorship, your key process involves procedures under paragraph 4.15 Handling, Storage, Packaging, Preservation, and Delivery. which must be documented. I have seen this done in freight forwarding where the company was dedicated to performing "distributor like" acitivities for another company. They achieved registration under a reputable reigstrar.

However, I would not recommend that you change your approach since, as Barb and Mark indicate, it sounds good and should work without any problem.
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