Calibration Procedure Level of Detail - ISO Procedure question

[huntdux]

I am currently working toward ISO 9001:2008 certification. One of our primary customers is "suggesting" that our procedures need more detail, i.e. the calibration procedure should mention the temperatures at which calibrations are conducted.
He would prefer that every procedure include who, what, when, where, you get the picture. My understanding of the standard is that detail on that level belongs in work instructions, not procedures. Where can I find guidance on what is and isn't required in written procedures? Thanks!

 

[AndyN]

I am currently working toward ISO 9001:2008 certification. One of our primary customers is "suggesting" that our procedures need more detail, i.e. the calibration procedure should mention the temperatures at which calibrations are conducted.
He would prefer that every procedure include who, what, when, where, you get the picture. My understanding of the standard is that detail on that level belongs in work instructions, not procedures. Where can I find guidance on what is and isn't required in written procedures? Thanks!

I'm not sure there is anywhere - other than conventional wisdom - that provides for such guidance. One consideration is that for the variety of equipment that you may be calibrating, such a procedure will doubtless become unwieldy and, therefore, difficult to maintain in the long term. One way of stopping such comments might be to have a process map for the overall calibration process, then link to various WIs etc for the details. You'd be hard pressed to include much detail (practically) in the process map - and you can refer to the notes in ISO 9001, under 4.1 (c) and 4.2.1 Notes 1 and 2

How has this (uneducated) suggestion come about? During an audit? Can you back charge them for extra work in writing these more detailed documents? Are you registered to ISO 9001 etc?

 

[Ninja]

Sorry for answering a question with questions...but you'll get used to it from me...

Your customer suggested something.
I personally agree with the "(uneducated)" in AndyN's post, but I'm also an outsider looking in.
Do you do your own calibration, or have an outside company do it?
If outside...you're done here...leave the procedure alone unless compliance with the customer's suggestion is necessary to gain business with the customer.
If you do it yourself...would it be cheaper to farm it out rather than write a more detailed procedure and follow it? Do you have a reasonable timeframe between recalibrations? and data to show it's reasonable?
What would be the impact on your business if you told the customer "thanks but no thanks" very tactfully?
More basic, does temperature have an effect on your gage?

Calibrate it so it works properly...you define proper (in light of your customer spec) and gather data (GRR) to show that it works properly...end of story. All the rest is you trying to get business and your customer trying to spend your money. They're good at trying, and often feel inadequate if they can't show you how you should "improve"...are you letting them succeed to the detriment of your business? Keep in mind, though, that sometimes the customer is actually right...and you can use thier feedback to improve your business toward greater profit.

JMO...

 

[JaneB]

I am currently working toward ISO 9001:2008 certification. One of our primary customers is "suggesting" that our procedures need more detail, i.e. the calibration procedure should mention the temperatures at which calibrations are conducted.
He would prefer that every procedure include who, what, when, where, you get the picture. My understanding of the standard is that detail on that level belongs in work instructions, not procedures. Where can I find guidance on what is and isn't required in written procedures? Thanks!

He may have a point about the temperatures. As for the rest... not necessarily.

As with Andy, I wonder how has this come about? Has your primary customer experienced or identified some kind of problem with your service/product, to which he's suggesting a possible solution?

Ultimately, it's your system, and what he would 'prefer' is just that - his preference. He may belong to a school of thought that always insists on huge amounts of detail in procedures... your system may put the detail elsewhere (eg, in work instructions). There's no right/wrong way!

Here's a couple of oft-overlooked bits out of the Standard that may help (my emphasis added):
0.1 General

The design and implementation of an organization's quality management system is influenced by
a) its organizational environment, changes in that environment, and the risks associated with that environment,
b) its varying needs,
c) its particular objectives,
d) the products it provides,
e) the processes it employs,
f) its size and organizational structure.

And immediately after that (0.1) again:

It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation.

Under 4.2.1 (Documentation):

NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to
a) the size of organization and type of activities,
b) the complexity of processes and their interactions, and
c) the competence of personnel.
NOTE 3 The documentation can be in any form or type of medium.

Ultimately, your system, your decision! Has to work for you, NOT him. BUT if he's an important customer, you may want to seek some kind of happy middle ground. eg, If he is uneasy about something, can you ease his mind by for example, showing him how your various parts of the system (which includes documentation but documentation is NOT the be-all and end-all of a sound system, just a part of it) fit together to produce the desired result?

 

[huntdux]

To provide some background, I am working toward certification for my company. The customer is pre-certifying us as a potential supplier for a component that is difficult to produce and has very limited sourcing. My biggest challenge is being certain that I am on solid ground. As a defense contractor, we are subject to a multitude of QAP's, SQAP's, MIL specs, etc. so the paper chase is massive.
That said, my understanding of ISO9001:2008 was exactly as you have noted, our system, our decision. My thought process while creating the QMS documentation was to keep it simple because it has to do double duty, we have both military and commercial clients.
We do almost all of our calibrations in house. The few items that we cannot calibrate are sent to labs.
I resolved the environment issue by including "Calibrations are performed i.a.w. ANSI/NCSL Z540-1 and ISO10012-1."

 

[druester]

Greetings huntdux: Being that you haven't said exactly what you are needing to calibrate I will take a guess that it is precision measuring tools (micrometers, calipers,etc.). We just went through our annual audit for ISO 13485:2003 and ISO 9001:2008. Calibration has never been an issue with us. I send out for calibration any instrument that can't be calibrated in-house. This would include ceramic gage blocks, laser mics, digital height gages. If there is an issue with hand tools ( micrometers, calipers, or indicators) I will send them out also. I have calibration work instructions for each type of tool in the shop that is used for production and inspection. The certs that are supplied for instruments that have been calibrated by an outside vendor always have the necessary information included. Remember, Do as you say, Say as you do. Also remember, If you didn't record it,it didn't happen. Documentation is CRITICAL.

 

[AndyN]

Remember, Do as you say, Say as you do. Also remember, If you didn't record it,it didn't happen. Documentation is CRITICAL.

I believe this is part of the OP's dilemma. Often too much emphasis is placed on documentation - which is what they are being asked to do. Less is more.

The idea of writing stuff down and then doing it is also a little outmoded. It was a mantra about obtaining certification to the 1987/1994 standards, which is no longer as accurate since doing what's written down, may not be effective...

 

[JaneB]

I believe this is part of the OP's dilemma. Often too much emphasis is placed on documentation - which is what they are being asked to do. Less is more.

The idea of writing stuff down and then doing it is also a little outmoded. It was a mantra about obtaining certification to the 1987/1994 standards, which is no longer as accurate since doing what's written down, may not be effective...

Yes, well said Andy.

As you say, that's the OP's dilemma for which he's seeking help: a customer is attempting to lever him into creating more documentation than he believes is needed, and in an overly detailed format.

It is time that the mantra 'say what you do, do what you say' (which I presume you're referencing) was dropped - preferably - or at the very least, updated to the 21st century! It is long outmoded, though catchphrases have a habit of hanging around long after their use by date expired.

It's easy to trot out a catchphrase. What's harder, but far more useful and ultimately more rewarding and is to get to grips with the Standard itself and its requirements. To think them through, understand them and then apply them. Intelligently, in a way that will suit the particular company. The customer in the OP's case doesn't sound as if he's doing that, but simply harking back to a model he knows and is familiar with. And perhaps simply has come to believe it's what 'ought to' be.

There was far, far too much emphasis on 'documenting everything' at one time, particularly dating from certification to the versions of the Standard cited by Andy (1987/1994). Those versions are completely obsolete and the Standard has moved on. So should and must the quality field.

 

[BradM]

I am currently working toward ISO 9001:2008 certification. One of our primary customers is "suggesting" that our procedures need more detail, i.e. the calibration procedure should mention the temperatures at which calibrations are conducted.
He would prefer that every procedure include who, what, when, where, you get the picture. My understanding of the standard is that detail on that level belongs in work instructions, not procedures. Where can I find guidance on what is and isn't required in written procedures? Thanks!

First, I am in agreement with Andy and Jane. One should always approach the QMS with intelligence and practicality. For example, if you only need to order 10 light bulbs, then what sense would it be to order 150?

Now... I would suggest this. Do give some thought to your current procedures. Is there room for improvement? Improve when you can; make them better. However, a blanket statement of adding more, to me, is not making them better.

As far as your calibration program, is it effective? Do you deliver good products/services? Are there failures related to calibration? If your procedures are assisting in producing good product?

A good example is the temperature. Instead of putting something about temperature in every procedure, why not have one to address environmental conditions? Then, temperature and humidity can be addressed.

I would thank the customer for their suggestions. After all, one should always welcome someone taking the time to make something better. Beyond that, I would approach your process of improving it by analyzing the results and seeing what is required.