G
gheghe
I was assigned to ensure respective areas has a documented procedure per ISO requirement and I need to track its progress. Any suggestion where to start and how to begin this?
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M
mshell
GheGhe,
I would start by making sure that you have the 6 required procedures
1. Control of Documents (4.2.3 of the standard)
2. Control of Records (4.2.4 of the standard)
3. Internal Audits (8.2.2 of the standard)
4. Control of Nonconforming Product (8.3 of the standard)
5. Corrective Action (8.5.2 of the standard)
6. Preventive Action (8.5.3 of the standard)
from there, your organization will need to determine what additional procedures are needed to ensure conformance to the requirements of the standard. It really varies from organization to organization. Typically, I implement a procedure if the absence of one could create a nonconforming situation.
Examples of the additional procedures that we have in place are:
1. Training
2. Sales Quote
3. Design & Development
4. Procurement
5. Shipping & Receiving
6. Production
7. Calibration
8. Measurement Analysis & Improvement
9. Customer Satisfaction
I hope that this helps.
I would start by making sure that you have the 6 required procedures
1. Control of Documents (4.2.3 of the standard)
2. Control of Records (4.2.4 of the standard)
3. Internal Audits (8.2.2 of the standard)
4. Control of Nonconforming Product (8.3 of the standard)
5. Corrective Action (8.5.2 of the standard)
6. Preventive Action (8.5.3 of the standard)
from there, your organization will need to determine what additional procedures are needed to ensure conformance to the requirements of the standard. It really varies from organization to organization. Typically, I implement a procedure if the absence of one could create a nonconforming situation.
Examples of the additional procedures that we have in place are:
1. Training
2. Sales Quote
3. Design & Development
4. Procurement
5. Shipping & Receiving
6. Production
7. Calibration
8. Measurement Analysis & Improvement
9. Customer Satisfaction
I hope that this helps.
C
Craig H.
Hi:
There are several things to consider here. First, how much information is needed? The goal here is to provide the information necessary for the worker (operator, manager, foreman, etc.) to do their job. Just as important, maybe even more important, is what is NOT needed. You don't want them to have to wade through 5 pages of "stuff" just to get that one piece of information they need. Balance. Take into account the abilities and training of those using the document.
One way to start this would be to draw a process map, or flowchart, of your process. That should give you an idea of the natural "breaking points" that each document, or set of documents, should cover. You may need to further break these subsections down, until you have a size that is manageable for one document. Again, try to develop documents that can be USED.
Don't forget the tools you have, as well. Some of the best procedures I have seen used a lot of digital pictures, with very little text. You can also use flowcharts, video, whatever works.
Cover the "shalls" in the standard. The rest is up to you. Please, though, do something that works, not just something that sits around until an audit. Look around the work site for "cheat sheets" already in use. They should give you an idea of what the workers think is important. Make sure to include that information in your documents.
I hope this helps at least some. Good luck!
There are several things to consider here. First, how much information is needed? The goal here is to provide the information necessary for the worker (operator, manager, foreman, etc.) to do their job. Just as important, maybe even more important, is what is NOT needed. You don't want them to have to wade through 5 pages of "stuff" just to get that one piece of information they need. Balance. Take into account the abilities and training of those using the document.
One way to start this would be to draw a process map, or flowchart, of your process. That should give you an idea of the natural "breaking points" that each document, or set of documents, should cover. You may need to further break these subsections down, until you have a size that is manageable for one document. Again, try to develop documents that can be USED.
Don't forget the tools you have, as well. Some of the best procedures I have seen used a lot of digital pictures, with very little text. You can also use flowcharts, video, whatever works.
Cover the "shalls" in the standard. The rest is up to you. Please, though, do something that works, not just something that sits around until an audit. Look around the work site for "cheat sheets" already in use. They should give you an idea of what the workers think is important. Make sure to include that information in your documents.
I hope this helps at least some. Good luck!
Claes Gefvenberg
Admin
Ah....I'm not sure I understand this right, but: Respective areas... It would probably be a better idea to ensure that your processes rather than areas are described. You could have a look at this old thread:Are we required by ISO 9001:2000 to have process maps for each department?gheghe said:
If you intend to have a documented procedure per area and std requirement I suppose you will end up with rather a lot of them... Do you really need that?
Remember this little gem:
What this note boils down to is that it allows you to build a reasonable system, tailored to your needs.ISO9001:2000 said:
/Claes
M
mshell
Good points Craig. 
Also, make sure that you involve the employees performing the work so that your procedures are accurate. I always have the employee who actually performs the function review and sign off on the procedure prior to implementation.
Also, make sure that you involve the employees performing the work so that your procedures are accurate. I always have the employee who actually performs the function review and sign off on the procedure prior to implementation.
C
Craig H.
mshell said:Good points Craig.
Also, make sure that you involve the employees performing the work so that your procedures are accurate. I always have the employee who actually performs the function review and sign off on the procedure prior to implementation.
Mshell
I have even had the four operators that do a particular job, one on each shift, write out what they did. Then I distilled that into 1 document, which I returned to them. Although they said beforehand "we all do it the same way", guess what? They didn't.
It took 4 iterations before we got everything worked out. That was several years ago, and we have had very few revisions since. It also opened their eyes to the fact that there were differences between them, and I think they communicate more as a result.
So, by taking your advice we can sometimes make sure "best practices'" are used on all shifts. That's a nice little side bonus, don't you think?
M
mshell
Yes a nice little bonus. 
The operators take ownership of the document. If the process and/or work method changes, they are the first ones to let me know that we need to update their document. We have actually made the operators the author of their own work instructions with the Supervisor giving final approval.
The operators take ownership of the document. If the process and/or work method changes, they are the first ones to let me know that we need to update their document. We have actually made the operators the author of their own work instructions with the Supervisor giving final approval.
We went so far as to have everyone from every shift (in a couple of strategic areas) come in on scheduled days off to work alongside their counterparts from each shift. They all made notes of things that they did or their counterparts did that were different and then distilled it all into a best practice. It cost us a little in overtime, but now each shift is confident that they are all working to the same practice. Before it was "how come xyz always happens on abcd shift?"Craig H. said:Mshell
I have even had the four operators that do a particular job, one on each shift, write out what they did. Then I distilled that into 1 document, which I returned to them. Although they said beforehand "we all do it the same way", guess what? They didn't.
It took 4 iterations before we got everything worked out. That was several years ago, and we have had very few revisions since. It also opened their eyes to the fact that there were differences between them, and I think they communicate more as a result.
So, by taking your advice we can sometimes make sure "best practices'" are used on all shifts. That's a nice little side bonus, don't you think?
Q
qualitygoddess - 2010
Checklist
I have a question -- are you only looking for procedures (level 2) for ISO 9001? Then you only need 6 procedures. What does your quality management system manual say -- are you looking for all procedures in your company, or just the ones required by ISO?
If you need to know if all requirements of ISO 9001:2000 have been met, then you may want to use a checklist. You can then go to each area, and verify that they have required procedures. You can make notes on the checklist, and then determine what areas still need certain procedures or instructions.
If you need a checklist, you can probably find it in a search on the Cove, or private mail to me, and I can send you one that I know has all the requirements listed by ISO 9001 section.
gheghe said:
I have a question -- are you only looking for procedures (level 2) for ISO 9001? Then you only need 6 procedures. What does your quality management system manual say -- are you looking for all procedures in your company, or just the ones required by ISO?
If you need to know if all requirements of ISO 9001:2000 have been met, then you may want to use a checklist. You can then go to each area, and verify that they have required procedures. You can make notes on the checklist, and then determine what areas still need certain procedures or instructions.
If you need a checklist, you can probably find it in a search on the Cove, or private mail to me, and I can send you one that I know has all the requirements listed by ISO 9001 section.
Craig H. said:
Very true! The trap that some organizations fall into is that they don't necessarily do what they say they do! This is because the documentation was developed by focusing only one shift/crew/individual and during the audit it's discovered that the documented process is not necesarily followed.
My organization talks about standardization. In some cases, we have 4 crews and 4 different ways of doing things. Standardization is 4 crews...one way...the right way...the effective way! In other words, the documented practice describes the best demonstrated practice (BDP).
Very often I have found that the BDP is a lovely blend from all those involved. Seldom is it exactly the way one crew does it. This leads to them all feeling a sense of ownership and pride in the documented practice.
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