QMS (Quality Management System) and Calibration Procedure

[Hershal]

Re: QMS and Calibration Procedure

Thanks. Plan B is to send out a gage block set to be certified and then reference that in the prodecure."Inspection tools to be verified with certified standard prior to use during inspection procedures". My issue now is time. I don't have alot to sit down an address all procedures/ work instructions required for all of my measuring devices. I figure I can update that at a later date and up the rev. on the main processs.

Plan A, send it to an accredited lab, will work until you can develop and implement Plan B - as a CHECK, not a calibration!

 

[Phil Fields]

I had them calibrate and refer to ISO-17025. I will be getting all certs back with my tools and hyperlinking them within my QMS so they are at a mouse click away.

As I go thru this process I am trying to be as organized as possible and think to the future not just what I am doing today but at 3 months, 6months a year etc. Is it advisable to add into my QMS procedures and work instructions now for how I want things to be at those points in time? Or should I just hold them in my bag of tricks and implement them at those time periods.

I guess what I'm asking is there a way to write them in now and say "coming soon..." or does that lead to issues with an auditor. Does it just make it more confusing?

Using the outside calibration service I think is a great way to go. As you choose suppliers and services remember to keep a file of how the suppliers were qualified.

Phil

 

[sagespecialized]

Phil, they are on my approved supplier list I have created and they will receive my survey here in a few days. I believe that should take care of the details. Next step, when I get the surveys back, is to put them on a spreadsheet and list their credentials and who their approved suppliers are for my info. That way if their not on my list I know not to use them or at least get them a survey for approval. This is going to be key, especially with process vendors because I've noticed just because you do work for a big fish doesn't mean your approved to do work for another. It will keep me from making assumptions as I look for process houses with my particular customers.

 

[Dan Johnson]

Re: QMS and Calibration Procedure

Be carefull here.
"I had them calibrate and refer to ISO-17025."
Basically, if you do in-house cal, you'll have to be certified (registered) to the same standard. it's much easier and cheaper, in the long run, to outsource cal services.

" Is it advisable to add into my QMS procedures and work instructions now for how I want things to be at those points in time? Or should I just hold them in my bag of tricks and implement them at those time periods." If your procedure meets the standard during the audit, keep that bag of tricks closed. When you want to initiate a change, generate a Preventive Action to do it. This shows continuous improvement, a primary principal of ISO.

Remedial action: This is being stressed these days. Have a plan on how you plan to perform a risk-analysis when you do (and you eventually will) have a tool come back that was out-of-tolerance when you sent it in. Just because it comes back serviceable doesn't mean you can ignore the initial cal test.

"I want my establishment to be driven by the documentation, most do it the other way around". What you want is for your QMS to be process-driven, not paperwork driven. What happens is that you write what you feel is a great procedure. Then when it has to be implemented, you find (at least I did, with 29 years of hands-on experience in my business), that there's problems at the floor level or that you've added non-value adding activities to your QMS, which reduces productivity. Think in terms of the start of the project (when you receive an order from a customer). Map out the steps to product completion. That's your process. Then you document it.

This is the reason that, in my industry, aviation, many companies are moving to the SAE standard, AS9100. It does a better job of what ISO is supposed to promote, a process-driven QMS.

But the best piece of advice I could give you has already been given by Brad and others "But for goodness sakes, keep it simple. It's easier to communicate, and a heck of a lot easier to stay in compliance."

 

[sagespecialized]

Hello Dan,

"I had them calibrate and refer to ISO-17025."
Basically, if you do in-house cal, you'll have to be certified (registered) to the same standard. it's much easier and cheaper, in the long run, to outsource cal services.

My initial plan is to start with the calibration house initially then as I grow and time allows start working on a set of procedures and work instructions that allow us to do it in house. At that point I will address the QMS with the proper wording that allows us to do it in house per our procedures and work instructions. Also upping the rev on the QMS accordingly. This will all be based on time vs. money vs. workload in the shop at the time our calibration requirements come due. I don't mind paying for it to be done outside if it allows my crew to be more productive inside. Is their a stat somewhere that has a breakdown of what it costs companies annually to maintain their certification status or calibration documents. It would be interesting to see, at least for my inexperienced eye.

Remedial action: Basically 3 strikes your out of service is how it is written now. Twice the tool will be allowed to be readjusted in it's life. If it comes back a third then it goes to tool heaven and gets put on the DOA list with the reason it is no longer with us.

"driven by the documentation" this is a wording error on my part. Documentation meaning the QMS manual and it's paperwork trail, not excess baggage that brings no value. I, as the owner, embrace ISO as a tool and I want the culture of my company to feel the same. No "judgement calls", no "I think we do it this way" etc etc, It is done one way and that of what is written. Now if an employee has a great idea and they feel it would make an improvement on the system, then i'm all ears and we can throw it on the floor and wrestle with it as a team. everybody buys in and implementation is a lot easier than a mandate.

Thank you all for the great advice as I journey forward.

 

[BradM]

Remedial action: Basically 3 strikes your out of service is how it is written now. Twice the tool will be allowed to be readjusted in it's life. If it comes back a third then it goes to tool heaven and gets put on the DOA list with the reason it is no longer with us.

This is a good start. However, as you progress in your program, you may want to expand your analysis/approach. Saying, I've seen a lot of good equipment disposed of based on the three strikes, and not because the instrument could not serve the process needs.

1. Determine what your process requirements are. While the piece of equipment may not be passing mfg. specifications, it is still sufficient for your need. Say you have a pressure gauge and it's mfg. spec. is +/-1 psi. However, as long as it's within +/-5 psi, it won't affect the process. If you dispose of the instrument because it's +/2psi when it's calibrated, you're getting rid of something that is fine for your process.

2. Determine why the instrument is failing. I have had instrumentation that would never (and I mean never) meet mfg. specifications. One was a multifunction calibrator (retail $6000 USD) Saying, it wasn't a cheap piece of junk. But.... we set process tolerances on it (what we needed it to achieve based on our process needs) and never had failures again. During calibration they would assess it and adjust, but as long as it was within the process tolerance, we did not write it as a failure.

All I am suggesting is to keep improving the calibration process as you go along. Review the data you receive from your instruments (which is why I would suggest to pay a little extra and get as-found/ as-left data). I hate to use a cliche, but manage the process so it is effective. Instruments are being sent out for calibration at the right time frames, not too soon, and definitely not too late. When you assess something as a fail, assure that it's really something that needs to be investigated. But do keep good notes and such on everything.

 

[Hodgepodge]

Re: QMS and Calibration Procedure

Be carefull here...Basically, if you do in-house cal, you'll have to be certified (registered) to the same standard. it's much easier and cheaper, in the long run, to outsource cal services.

There is no requirement to be certified or registered as a calibration facility to any standard. You can perform the calibrations in house as long as you meet the requirements (my emphasis in bold).

ISO 9001 Section 7.6...
The organization shall establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements.

The requirement that relates to this part of the discussion is:

ISO 9001 Section 7.6...

Where necessary to ensure valid results, measuring equipment shall​

a)

​

be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded.​

If you send your gage blocks out for calibration, you can use them to trace your internal calibrations to national standards.

 

[Hodgepodge]

Remedial action: Basically 3 strikes your out of service is how it is written now. Twice the tool will be allowed to be readjusted in it's life. If it comes back a third then it goes to tool heaven and gets put on the DOA list with the reason it is no longer with us.

Remedial action on equipment isn't the only action you must take.

ISO 9001 Section 7.6...In addition, the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The organization shall take appropriate action on the equipment and any product affected.​

I suggest you plan on how you are going to determine the effect the out-of-tolerance equipment had on the product it was used to inspect. This may include re-inspection of work in progress and even contacting the customer to determine the quality of product already shipped. ​

Plan ahead by recording the identification of each piece inspection equipment used to determine product quality when taking measurements. This will make each measurement traceable to the calibration certificate/report.​

 

[sagespecialized]

Hello Hodgepodge, it is written in my QMS that any non conforming product found to be the fault of faulty calibration will be subject to 100% re-inspection and possible recall from the customer of other parts in question. all tool serial numbers will be documented on the inspection reports accordingly for the ease of tracking which parts were inspected with what tools.

Eventually there will be 4 levels of inspection on all products. The engineer creating the cnc program, the machine setup guy/ girl doing setup and 1st piece verification, the inspector verifying the 1st piece dimensions and accompanying paperwork then the operator at the production level.

I am going to be proactive at the machine level with all inspection duties and try to avoid having a bottle neck in the quality department doing final dimensional inspection. I would like to see final be a visual inspection with putting together the final documents required by the customer. The documented history of the parts will come from the machinist on the floor. My opinion is that by the time all is said and done and the parts are in final inspection it is to late to make any corrections on that processed lot.

 

[Hodgepodge]

...Eventually there will be 4 levels of inspection on all products. The engineer creating the cnc program, the machine setup guy/ girl doing setup and 1st piece verification, the inspector verifying the 1st piece dimensions and accompanying paperwork then the operator at the production level.

I am going to be proactive at the machine level with all inspection duties and try to avoid having a bottle neck in the quality department doing final dimensional inspection. I would like to see final be a visual inspection with putting together the final documents required by the customer. The documented history of the parts will come from the machinist on the floor. My opinion is that by the time all is said and done and the parts are in final inspection it is to late to make any corrections on that processed lot.

Sounds like a great start. Your inspection system can be adequate depending on the complexity of the product. Preventive measures are better than post-production inspection measures. That being said, have you considered performing a first article inspection? This would be an inspection of one piece on every characteristic. You could record this type of inspection for each part number. It would need to be done again for the same part number only when a manufacturing change or drawing revision change is made (not very often). Though it is not an ISO 9001 requirement, and again, depending on the complexity of the parts you are making, it could prove to be very beneficial. Think of it as an audit of the entire manufacturing process, from planning, to programming, machining, purchasing, inspection, and documentation. Just a thought.