How do you decide what is a Process, a Procedure or Work Instruction?

[nickyquality]

1. Everything's a PROCESS. It's usually just a matter of how anal you want to get about your systems. Focus on processes that can affect your customer in any way.
2. A PROCEDURE details processes that cross departmental lines (requires approval from more than one manager / supervisor)
3. A WORK INSTRUCTION details processes within a department (only requires approval from one manager / supervisor)

Our company is also busy with the QMS system and will have a different manual for each department, will you call those procedures, rather WI's?

 

[Helmut Jilling]

Helmut, I can't 'see' any 'number' that tells us whether these procedures are 'working'! The number of findings from an audit is open to too much variability to be an indicator of the procedure! The same for document control, records control and the others! They are ALL subject to variances which make any numerical value applied to monitor/measure them almost a waste of time.

Should a corrective action take 30 days? Should there be less than 10 instances of non-conforming product? Should it take less than 8 hours to review and approve a document?

I'd like to see the look on senior management's face when someone tells them that 'ISO says' they have to put resources behind gathering data on these procedures - which are far removed (in most cases) from the revenue/value adding processes of the business!

Note, I was discussing processes not procedures.

Measuring a process would use numbers and data. Monitoring can be much more simple and basic. As in, my clients "monitor" whether they feel they get value from my audits.

But, I disagree that there is no value on this. Companies spend $1000's on internal audits, often without useful results (as you often point out). Same for doc control and others. Setting criteria for those processes and monitoring or measuring whether the results achieve the criteria is fully in line with the objective of cl 4.1/ I spend significant time helping clients get value from that part of their systems.

Two examples are value from findings, and reduced time and effort going into Doc Control.

 

[nickyquality]

Note, I was discussing processes not procedures.

Measuring a process would use numbers and data. Monitoring can be much more simple and basic. As in, my clients "monitor" whether they feel they get value from my audits.

But, I disagree that there is no value on this. Companies spend $1000's on internal audits, often without useful results (as you often point out). Same for doc control and others. Setting criteria for those processes and monitoring or measuring whether the results achieve the criteria is fully in line with the objective of cl 4.1/ I spend significant time helping clients get value from that part of their systems.

Two examples are value from findings, and reduced time and effort going into Doc Control.

This Document control is a headache, we will have the following: Quality Manual, HR Manual, Employee Induction handbook, Admin Manual, IT Manual, Finance Manual, Marketing Manual and Project Manual. To Control this documents is a nightmare.
Any suggestions?
Please, HELP!!!!

 

[Helmut Jilling]

Our company is also busy with the QMS system and will have a different manual for each department, will you call those procedures, rather WI's?

I would call them SOPs and be done. I also would not make a separate manual for each department.

 

[AndyN]

Note, I was discussing processes not procedures.

Measuring a process would use numbers and data. Monitoring can be much more simple and basic. As in, my clients "monitor" whether they feel they get value from my audits.

But, I disagree that there is no value on this. Companies spend $1000's on internal audits, often without useful results (as you often point out). Same for doc control and others. Setting criteria for those processes and monitoring or measuring whether the results achieve the criteria is fully in line with the objective of cl 4.1/ I spend significant time helping clients get value from that part of their systems.

Two examples are value from findings, and reduced time and effort going into Doc Control.

I think the value comes from the content of such things, not the number of them (like audit findings) or time to process (like document approvals). Here's the rub! It's a more difficult task to determine those things!

You are correct - of course - Helmut, that companies spend $1000's on auditor training and slick documentation systems. It's easy to enumerate the OFIs and DCRs and weeks and hours and CARs etc. But they tell very little of the story.

An example I found was concerning nc products. The place was awash with yellow tags on which were written such illuminating comments as 'oversize' etc. I appealed to the QM who did his best (corporate QM) response to say - "There's less of them than there was over the last 10 months!" (You might guess who he had worked for previously, but they were bankrupt a while ago)

My response? "So what?" If you can't determine which feature is how much oversize how do you know the total volume is down - it might be because you're not making as much!

 

[Helmut Jilling]

I think the value comes from the content of such things, not the number of them (like audit findings) or time to process (like document approvals). Here's the rub! It's a more difficult task to determine those things!

You are correct - of course - Helmut, that companies spend $1000's on auditor training and slick documentation systems. It's easy to enumerate the OFIs and DCRs and weeks and hours and CARs etc. But they tell very little of the story.

An example I found was concerning nc products. The place was awash with yellow tags on which were written such illuminating comments as 'oversize' etc. I appealed to the QM who did his best (corporate QM) response to say - "There's less of them than there was over the last 10 months!" (You might guess who he had worked for previously, but they were bankrupt a while ago)

My response? "So what?" If you can't determine which feature is how much oversize how do you know the total volume is down - it might be because you're not making as much!

Sure it's a more difficult task to determine those things. That is why management teams must determine the criteria that are meaningful to them and/or their customers.

I also agree that what you described would not be effective, and the monitoring or auditing of that NCM activity should show that.

 

[AndyN]

Sure it's a more difficult task to determine those things. That is why management teams must determine the criteria that are meaningful to them and/or their customers.

I'm not sure what happens these days, but I'm struck by a recollection of the most common question we heard at the closing meeting at the CB initial audit:

"How does this number of ncs compare to other places you've been?"

I'm not going to hold my breath until management fully understand the most appropriate way to measure or monitor the '6 Procedures' of ISO!

 

[Stijloor]

<snip> "How does this number of ncs compare to other places you've been?"

That's called "benchmarking!"

Stijloor.

 

[nickyquality]

I would call them SOPs and be done. I also would not make a separate manual for each department.

Hi Helmut

I really don't know anymore what to do? What will you call the Manual then?

 

[John Martinez]

I like the cake analogy. I like the reference to the TC 176 guidance documents. I like the description of the levels of documents.

What I did not see so far are the ISO 9000:2005 definitions:

3.4.1
process
set of interrelated or interacting activities which transforms inputs into outputs

3.4.5
procedure
specified way to carry out an activity or a process (3.4.1)

Definition of procedure describes either a procedure or work instruction so two levels of instructions (procedure) and more detailed “how to” (work instructions) fit this definition.