Do We Have to Comply with Our Own Procedures?

[barb butrym]

we are doing process audits now.......right? aren't our process' our procedures?...LOL

WI vs P........NOT AGAIN????????????????

A level 2 tells you what is to be done, A WI tells you how.....So why not combine the 2??????????? Unless it makes the document (notice I was generic? ) too long...and to me more than 1 page is long

any one else?

[noboxwine]

Never responsible for grammatical errors of any type.
Greetings BB and all: Last time I read ISO/TR 10013- Guidelines for QMS Documentation, I found dozens of should’s. Hence, here’s what I have done with Procedures vs. Work Instructions. First, I combine both of them and dub them a Process Instruction (call ‘em doilies, if you want, who cares)- a quality document that both shows you what objective is to be done and how it is achieved. Secondly, they are never more than one page. Granted, a couple of them are on an 11” x 17” layout, but still only one page. No flipping back and forth like we still do with time honored multi-level bullet and verbiage-laden procedures that impress 3rd party folks. Thirdly, they’re bright and colorful and electronic and flow charty and hyperlinked to all other reference documents. Here’s the moral of the story: construct your documents, however you feel they appear effective and have a couple people, with limited knowledge of that process, go through a dry run to see if they are useful. If so, you’re done. Miller Time. If not, make the appropriate changes until they are effective.

Should we follow them? Is it easier to a) circumvent a system or b) comply? If you choose a), you may want to ask yourself why.

This format works well for our manufacturing and distribution business. It may not be possible in all businesses to simplify them as much as we do here. But, I was pleased and surprised when I began trying it because it forced me to keep it simple and short; then voila, it worked! Common sense is a terrible thing to waste. Put the documents in the places need in the appropriate format and make them work, period. Am I missing something? A great day to all. May your Cpk always be a positive integer.

[John Broomfield]

In Reply to Parent Post by M Greenaway

Well that should grab some attention.

Just wondering where the old 4.9.c clause of the 1994 standard has its equivalent in the 2000 standard.

This is the clause that those of you who only audited for compliance to procedures were actually auditing, but it doesnt appear to be in the 2000 version.

Therefore is it no longer a requirement to comply with your own procedures ?

Let the fun begin.........

Yes, the pre-2000 ISO 9001 requirement was obedience…

"Clause: 4.9

The supplier shall identify and plan the production, installation, and servicing processes which directly affect quality and shall ensure that these processes are carried out under controlled conditions. Controlled conditions shall include the following:

Subclause: c)

Compliance with reference standards/codes, quality plans and/or documented procedures"

ISO 9001:2000 changed all that. No longer does ISO 9001 specify that the employees shall obey their organization's plans, procedures or instructions.

If obedience is required this is management's job not ISO's.

So, if an employee is not following procedures find out if the process is being monitored (see 8.2.3). Then ask what happens when the process and procedure do not conform. Find out how management helps employees to meet requirements.

Do not report employees for failing to follow procedures - find out why and report the system weakness instead. You will end up with better corrective action.

John

[Sidney Vianna]

In Reply to Parent Post by John Broomfield

No longer does ISO 9001 specify that the employees shall obey their organization's plans, procedures or instructions.

A 10 year old thread resurrected....

4.1 of ISO 9001 talks about determining methods (procedures, work instructions, command media, etc.) related to the QMS processes. Further, it requires organizations to implement actions to ensure processes are deployed.

If we agree that we develop documentation to define how processes should operate, a requirement for implementing actions reads, IMO, as: follow the procedures. You can not truly implement processes if one deviates from the documentation that describes how the process is supposed to be carried out.

[Quality_Steve]

IMO...If you are not following the process/procedure as written then you should ask yourself, is the process/procedure necessary? If it's not a necessary process, as in it has no influence on the finished product and not required by ISO, get rid of it! If it is necessary, is the process written to align with best practices? If the actual process achieves the same or better results than the written process, it time to re-write the process.

The problem I run into is we write great processes and people will choose not to follow the process through carelessness or impatience.

If it takes a little longer to do it right the first time, it is still quicker than doing it twice.

But I digress, I was handed a QMS three months before certification. I had little knowledge of ISO or quality in general. I had to quickly polish up what was already written, find the holes, and make it work. Now that we are certified, I have had the time to really look at things and see if they make sense. I have found that we have over-documented everything. We have process flows for filling out forms.

The Cove has been a very helpful resource!

[John Broomfield]

In Reply to Parent Post by Sidney Vianna

A 10 year old thread resurrected....

4.1 of ISO 9001 talks about determining methods (procedures, work instructions, command media, etc.) related to the QMS processes. Further, it requires organizations to implement actions to ensure processes are deployed.

If we agree that we develop documentation to define how processes should operate, a requirement for implementing actions reads, IMO, as: follow the procedures. You can not truly implement processes if one deviates from the documentation that describes how the process is supposed to be carried out.

Sidney,

I resurrected this discussion because it had not been concluded with what ISO 9001 actually specifies when comparing the 1994 and 2000 versions.

And yet we still see auditors reporting employees for failing to conform to procedures as a nonconformity to ISO 9001:2008. Now they no longer have the old 4.9c clause they even have to imagine the requirement to do so!

Implement means use the organizational management system to put it into effect including its many provisions for managing change. Implement does not mean conform to procedures that may not work.

Sure, management may require conformity. But ISO 9001 no longer specifies that employees shall conform to the plans, procedures or instructions.

May I suggest the acid test is the 7.5.2 for validated processes? The specific methods have to be used but the requirement to conform to the specific methods is left to management.

John

[John Broomfield]

In Reply to Parent Post by Quality_Steve

IMO...If you are not following the process/procedure as written then you should ask yourself, is the process/procedure necessary? If it's not a necessary process, as in it has no influence on the finished product and not required by ISO, get rid of it! If it is necessary, is the process written to align with best practices? If the actual process achieves the same or better results than the written process, it time to re-write the process.

The problem I run into is we write great processes and people will choose not to follow the process through carelessness or impatience.

If it takes a little longer to do it right the first time, it is still quicker than doing it twice.

But I digress, I was handed a QMS three months before certification. I had little knowledge of ISO or quality in general. I had to quickly polish up what was already written, find the holes, and make it work. Now that we are certified, I have had the time to really look at things and see if they make sense. I have found that we have over-documented everything. We have process flows for filling out forms.

The Cove has been a very helpful resource!

Quality Steve,

Three questions:

1. Who requires employee conformity to procedures?
2. How do they make this clear to the employees?
3. Do they cite an ISO requirement to conform or is it their own?

Managers may also say "use it or improve it".

By the way, well done!

John

[Quality_Steve]

In Reply to Parent Post by John Broomfield

Quality Steve,

Three questions:

1. Who requires employee conformity to procedures?
2. How do they make this clear to the employees?
3. Do they cite an ISO requirement to conform or is it their own?

Managers may also say "use it or improve it".

By the way, well done!

John

Very good questions! I believe these views have been pasted down from different parts of the organization that have been ISO certified since 1994. I would have to say it more management requiring conformity than anything. Many of the requirements we impose upon the production floor are stated in their quality log instructions.

I've always heard the old saying, "Say what you do and do what you say."

Now you make me question the very foundation in which I stand on