Small Laboratories & ISO 17025 Clause 4.1.4 - Small company 4 employees

[Jim of Sonoma]

We are a small company (4 employees) which manufactures and calibrates measurement equipment. Each one of us is in some way involved with the manufacturing, and calibration of our products. The requirement is to identify possible conflicts of interest, and the note mentions production as being a possible conflict with calibration. Even product design could be seen as a possible conflict with calibration. Any suggestions on how we can meet this requirement without hiring additional staff?

 

[Marc]

Re: Small Laboratories and ISO 17025 Section 4.1.4

Any thoughts on this, folks?

 

[BradM]

[FONT=Arial,Bold][FONT=Arial,Bold]I think there are more here that might can help with this one. Here is the citation the OP is interested in:[/FONT][/FONT]​

[FONT=Arial,Bold][FONT=Arial,Bold][FONT=Arial,Bold][FONT=Arial,Bold]4.1.4 [/FONT]

[/FONT]If the laboratory is part of an organization performing activities other than testing and/or calibration,​

the responsibilities of key personnel in the organization that have an involvement or influence on the testing​

and/or calibration activities of the laboratory shall be defined in order to identify potential conflicts of interest.​

[/FONT][/FONT]

I think Note 2 provides you the best reference:​

NOTE 2 If the laboratory wishes to be recognized as a third-party laboratory, it should be able to demonstrate that it is impartial and that it and its personnel are free from any undue commercial, financial and other pressures which might influence their technical judgement. The third-party testing or calibration laboratory should not engage in any activities that may endanger the trust in its independence of judgement and integrity in relation to its testing or calibration activities.​

I do say I see your situation, and am not sure how clearly the lines can be drawn.

I'm just throwing some ideas out here:

1. Is there any way your customers could witness your calibration testing?
2. Could you have one person that is responsible for quality, and is as isolated as possible from manufacturing? Could that person's performance reviews and raises not be tied to the manufacturing success of the operation as much as the others?
3. Could you survey and discuss with your customers and assure they are satisfied and are seeing the same results you are producing?
4. Is there a clear distinction of reporting and such between the people doing the calibration and whoever runs the organization?

I would say this question is a good one to take up with your auditor. Main thing-try to develop as much impartiality as possible within the testing/calibration function. You always want to give the impression that the calibration work does not "cover up" for the manufacturing end. They would note/raise any quality testing issues regardless of the financial impact to the manufacturing/sales portion.

 

[Jim of Sonoma]

Thanks for the response. Currently I am just looking into 17025, it would make sense for us in many ways, but just trying to figure out if it is feasible. So at the moment I don't have an auditor I can ask.

1. Is there any way your customers could witness your calibration testing?

we have had one customer do this but it is not at all practical for most.

2. Could you have one person that is responsible for quality, and is as isolated as possible from manufacturing? Could that person's performance reviews and raises not be tied to the manufacturing success of the operation as much as the others?

Perhaps, we do have one employee who does most of the calibrations, I'll explain more below.

3. Could you survey and discuss with your customers and assure they are satisfied and are seeing the same results you are producing?

Yes, but would that satisfy the requirement?

4. Is there a clear distinction of reporting and such between the people doing the calibration and whoever runs the organization?

Technically everyone reports to me, and I would also be the Quality Manager, but we each have our own areas of expertise, one thing that I like about how things are set up is it not at all uncommon for any of us to take instructions from anyone else.

We only test products which we manufacture, and we only have a few product lines. As I think about our situation some more I realize that about a third of our products give more visual qualitative results, so they are not calibrated and we would want to keep them outside of the scope of 17025. Another third are manufactured by one person and then I do the final test, so there should be no problem there. The final third are manufactured and calibrated by one person, about 80% of the job is calibration, the position is primarily a calibration position, the employee has a PhD, and there is no undue outside pressure. But just need to determine if I can make that case?

 

[True Position]

Yes, but would that satisfy the requirement?

Is it possible you could do some type of interlaboratory comparison? I know I used to deal with one which would send me a couple parts to dimensionally layout then collect data and show how well you did and how you did in comparison to other labs.

 

[BradM]

...The final third are manufactured and calibrated by one person, about 80% of the job is calibration, the position is primarily a calibration position, the employee has a PhD, and there is no undue outside pressure. But just need to determine if I can make that case?

I know this sounds circular, but can you demonstrate the case? That to me would be the thing. That you can provide some kind of demonstration that this one person job can act upon things without feeling undue hardship.

Like True Position suggested, can someone else calibrate the devices? If you can provide evidence that an independent lab gets the same results that you do, that could further build your case.

 

[Hershal]

This may have some answers that hopefully are not too burdensome.

ISO/IEC 17025 Clause 4.1.4 basically is getting at making sure there is no conflict of interest. First thing to be done is have definition to the process. Everyone is wearing what seems like 26 hats, so the key is that each one knows which hat they are wearing, when they are wearing it, and what is required. In small companies that is the first step.

BradM is also correct, you need a primary and also deputy for quality, and same for technical. These are the folks that have the responsibility for those functions, even though everyone takes care of it in reality.

Hope this helps. Keep the questions coming!

 

[Jim of Sonoma]

Thanks, that does make sense that we need to define who is wearing what hat at a particular point in the process. I might be able to reduce the assembly load on the person who does the calibrations to the point were he is not in charge of assembly of those products.

Looks as though the other manufacturers in the field are not 17025 accredited, so I can't exactly do an interlab comparison with accredited labs, but there are a few other manufacturers who are well respected and would carry some weight. Although we do calibrate our standards before sending them to NIST to see how close our results are, so perhaps that would count as some kind of comparison.

We can have deputy quality and technical managers. We do actually have another division which makes completely unrelated products. The manager of that division does help with the internal audits, could I have the same person who does the internal audits also be the deputy quality manager? Can I be both quality manager and technical manager?

 

[BradM]

We can have deputy quality and technical managers. We do actually have another division which makes completely unrelated products. The manager of that division does help with the internal audits, could I have the same person who does the internal audits also be the deputy quality manager? Can I be both quality manager and technical manager?

I think having the other individual involved with your quality program is a good thing. That way, a fresh pair of eyes sees your process and can comment on it.

Man... if there was any way to separate the technical and quality manager role, that would be excellent. However, I know how it is. If you can establish a process where the decisions you make while doing technical manager role does not influence the quality manager role, then that should suffice.

 

[Jim of Sonoma]

Ok maybe this will be a better setup: our calibration guy will be the technical manager, I'll be quality manager and deputy technical manager, our purchasing and accounting person will be the deputy quality manager, and the outside manager will run the internal audits and would be assigned some of my responsibilities in the event of my absence (2nd deputy quality manager?).

We'll organize larger production runs which will be done by everyone with the calibration person doing component testing, I'm debating whether I can be in charge of these or if we should have our shipping/production person be assigned? I suppose the best would be to assign him as the production manager, with it being clear in our procedures that I'll play a role in the production as well.