Do We Have to Comply with Our Own Procedures?

[Big Jim]

Reference to 7.5.2 is a red herring IMHO. There is sufficent reference to use of documented procedures (confusingly called work instructions) here:

There are plenty of processes where it is possible to verify the output (so not covered by clause 7.5.2) but, for reasons of speed or cost you wouldn't want to do this on every product. instead an organisation might choose to document the production procedure as a means of providing additional control of the process.

Clause 7.5.2 only applies to processes and the requirement for is after the process has been validated. An example might help:

Welding is one of the classic special process that comes under 7.5.2. In many industries where welding is used control is exercised through use of competent people. In others it is through use of calibrated equipment and in many industries - particularly using structural or safety critical welds welding procedures are developed covering:

• welder qualification;
• equipment type and calibration;
• number of welds;
• direction and orientation of each weld pass;
• the welding consumables to be used for each pass;
• speed and feed rates for weld consumables to control material deposition; and
• post weld treatment processes

The weld procedure is developed during product design and development and generally a completed weld is sectioned and destructively tested to validate that the weld will give the necessary structural strength before the weld procedure is approved and issued for production.

Of course when this procedure is issued people can choose whether they follow it or not.

A better example of the need to follow a procedure for the process to come out correctly might be plating. Plating follows a specification, which may loosely be called a recipe. Proof that you follow the recipe (records of process controls) would be records of validation.

Welding using certified welders as you described probably better fits under 7.5.2 b "approval of equipment of and qualification of personnel".

 

[Paul Simpson]

We're rapidly approaching 'I wish I hadn't bothered' territory! I should have known but ignored the signs.

A better example of the need to follow a procedure for the process to come out correctly might be plating.

I specifically chose welding 1) because it's a classic example used everywhere, and 2) because I used it to highlight alternative methods for 'arrangements for ... processes' post validation to 'achieve planned results' - but I'm happy to use your example.

Plating follows a specification, which may loosely be called a recipe. Proof that you follow the recipe (records of process controls) would be records of validation.

In the process of developing the 'recipe' the organisation will normally produce parts, carry out metallurgical sections of the plated component(s), carry out some accelerated life testing using salt spray (for example) etc. The records of these tests are the record of validation of the process.

Proof that you follow the recipe is evidence you are working to the process as validated or, to paraphrase my words above you are following 'arrangements for ... processes' to 'achieve planned results'

Welding using certified welders as you described probably better fits under 7.5.2 b "approval of equipment of and qualification of personnel".

Agreed. I try not to use the clause numbering unless I feel the need to explain where my thinking comes from. So in the example list I quoted (reproduced below) all the items would generally be included in a welding procedure / specification (under 7.5.2 c). Where the procedure includes another part of the clause is (again IMHO) irrelevant - but here they are anyway.

- welder qualification (b);
- equipment type and calibration(b);
- number of welds (c);
- direction and orientation of each weld pass (c);
- the welding consumables to be used for each pass (c);
- speed and feed rates for weld consumables to control material deposition (c); and
- post weld treatment processes (c)

• 1 There are certain situations in most organisations where inputs are turned into outputs (process) in a better way if the person / people working in the process follow a prescribed set of steps in a certain way (procedure). For ease of reference this is often captured in media in some way (documented). It may or may not be possible to verify through monitoring or measuring that the output is correct.
• 2 The simple fact that someone with the authority to document a procedure has done so means that anyone who works in the process must / shall / has to follow the procedure.
• 3 An audit of the area must / shall / has to include some assessment of whether the people in the process are following the documented procedure.

 

[plantengineer]

Just my take...if you have it written in your procedure, then you have to perform it. Your procedure states how you are going to handle something, and even if it's "no longer required" by an updated revision, you still have it in YOUR procedure...you do it.

If you don't want to perform it, then you should revise your procedure as such, but if it's in, then it's done...

 

[Quality_Steve]

Thank you all for your posts.

I have learned so much from both sides of this debate.

I will begin training our auditors first to follow the process. I don't feel our auditors are seasoned enough to effectively audit the monitoring of the process, yet.

I do hope to get them there. :

Hitting the process from both ends seems like it would produce great results.

Ideally, I would like to see our auditors follow the process and find what's working and what's not. Then bring it back to the process owner and audit them about what was found. Basically audit the monitoring of the process backwards.

That's the direction I will take for now.



Steve

 

[Big Jim]

We're rapidly approaching 'I wish I hadn't bothered' territory! I should have known but ignored the signs.
I specifically chose welding 1) because it's a classic example used everywhere, and 2) because I used it to highlight alternative methods for 'arrangements for ... processes' post validation to 'achieve planned results' - but I'm happy to use your example.
In the process of developing the 'recipe' the organisation will normally produce parts, carry out metallurgical sections of the plated component(s), carry out some accelerated life testing using salt spray (for example) etc. The records of these tests are the record of validation of the process.

Proof that you follow the recipe is evidence you are working to the process as validated or, to paraphrase my words above you are following 'arrangements for ... processes' to 'achieve planned results'

Agreed. I try not to use the clause numbering unless I feel the need to explain where my thinking comes from. So in the example list I quoted (reproduced below) all the items would generally be included in a welding procedure / specification (under 7.5.2 c). Where the procedure includes another part of the clause is (again IMHO) irrelevant - but here they are anyway.

• 1 There are certain situations in most organisations where inputs are turned into outputs (process) in a better way if the person / people working in the process follow a prescribed set of steps in a certain way (procedure). For ease of reference this is often captured in media in some way (documented). It may or may not be possible to verify through monitoring or measuring that the output is correct.
• 2 The simple fact that someone with the authority to document a procedure has done so means that anyone who works in the process must / shall / has to follow the procedure.
• 3 An audit of the area must / shall / has to include some assessment of whether the people in the process are following the documented procedure.

In the plating example, the plating shop usually does not develop the recipe. That would be the MIL spec or the like that the organization told them to plate to as part of the purchasing information. Someone else figured out the recipe, usually long ago.

 

[Paul Simpson]

In the plating example, the plating shop usually does not develop the recipe. That would be the MIL spec or the like that the organization told them to plate to as part of the purchasing information. Someone else figured out the recipe, usually long ago.

Really?

My experience of specifications (and I confess it doesn't extend to MIL Specs for plating. ) is that the specifier normally writes up what they want achieved:

• required plating thickness
• adherence of the deposited material to the substrate
• durability - accelerated testing requirements e.g. salt spray, abrasion testing

They leave the how to the process experts. So for a component of a given size / shape / complexity the plater decides:

• what is the best method for preparation of substrate - pretreatment
• Anode composition
• How long in the bath
• key chemical(s) in the solution
• bath temperature
• applied voltage
• desired current

But perhaps you could post an extract so we can compare your ideas and mine?

 

[Big Jim]

Really?

My experience of specifications (and I confess it doesn't extend to MIL Specs for plating. ) is that the specifier normally writes up what they want achieved:

• required plating thickness
• adherence of the deposited material to the substrate
• durability - accelerated testing requirements e.g. salt spray, abrasion testing

They leave the how to the process experts. So for a component of a given size / shape / complexity the plater decides:

• what is the best method for preparation of substrate - pretreatment
• Anode composition
• How long in the bath
• key chemical(s) in the solution
• bath temperature
• applied voltage
• desired current

But perhaps you could post an extract so we can compare your ideas and mine?

I guess that you and I hang out at different plating shops and different customers that use their service.

It is true that the plating shop has to allow for thickness, and do the math to determine how long to leave it in the tank as well as how to set the rectifier, but the spec still provides critical parameters. In particular the key chemicals in the solution is determined by the spec, not by the plater. The plater needs to constantly monitor and adjust the tank chemistries to keep them in spec.

 

[Jim Wynne]

I guess that you and I hang out at different plating shops and different customers that use their service.

It is true that the plating shop has to allow for thickness, and do the math to determine how long to leave it in the tank as well as how to set the rectifier, but the spec still provides critical parameters. In particular the key chemicals in the solution is determined by the spec, not by the plater. The plater needs to constantly monitor and adjust the tank chemistries to keep them in spec.

Typical plating specs (ASTM B633 for zinc on steel, e.g.) do not specify bath chemistry.

 

[Paul Simpson]

I guess that you and I hang out at different plating shops and different customers that use their service.

I don't know, Jim. You raised the topic.

It is true that the plating shop has to allow for thickness, and do the math to determine how long to leave it in the tank as well as how to set the rectifier, but the spec still provides critical parameters. In particular the key chemicals in the solution is determined by the spec, not by the plater. The plater needs to constantly monitor and adjust the tank chemistries to keep them in spec.

Again, rather than discuss the differences between my opinion and yours perhaps you could post an excerpt of one of the specs for people to have a look at. Factual approach to decision making.

 

[AndyN]

A better example of the need to follow a procedure for the process to come out correctly might be plating. Plating follows a specification, which may loosely be called a recipe. Proof that you follow the recipe (records of process controls) would be records of validation.

Welding using certified welders as you described probably better fits under 7.5.2 b "approval of equipment of and qualification of personnel".

You must hang out in different weld shops than I've experienced, Jim! It may not have appeared on your radar screen, but there's a professional qualification, called "Welding Engineer'. In my experience, these are the engineers who determine what's the most appropriate welding procedure to accomplish specific joint. This can include such diverse topics (unrelated to the actual welding equipment) as:

Materials selection
Material pre-treatment (heating annealing)
Physical geometry of the edge profiles
Weld run layouts, sequence, duration, length (to control distortion etc)
Post weld treatments, weld dressing, heat treatments etc.

I fully agree with Paul assertions. I was also heavily involved with platers and anodizers and no-where in the specifications did it give the 'recipe' as you put it, but it did describe the sequences (in chroming for example) and the relative thicknesses which may typically be achieved. In a related world, that of printed circuit manufacture, those suppliers would have thrown us out, if we'd put the recipe on the drawings - we simply stated the tin/lead ratio, thickness and such like.