Calibration Methods - Auditor wants federal or international calibration procedures?

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#11
Originally posted by chen:
i think it is better to use national calibration procedures directly or convery it to your company procedures.
I believe this is more a factor of the level of expertise in your company than anything else. If you don't have a qualified person to write your cal procedures, use a national standard if available. Typically a qualified technician is aware of existing national standards and knows whether to use them or to derive a procedure which fits the equipment. It should also be noted there are no national 'standards' for many types of equipment. Thus, this is not always an option.

My personal preference is Manufacturer's Recommended procedure be considered first.

[This message has been edited by Marc Smith (edited 01 June 2000).]
 
Elsmar Forum Sponsor

Jerry Eldred

Forum Moderator
Super Moderator
#12
I'll reply to a couple of points above.

1. The preference to use only national type procedures. There is certainly nothing wrong with that. It does make things simpler in an audit. But it is not necessary. If you are a US DOD contractor (or Canadian), it also saves expense. I have a preference to use GIDEP procedures, and utilize them where ever possible (and where it adds value or saves expense). But I would stand up to any auditor as for writing the procedure internally. The only holes I believe an auditor could poke in internally written procedures is as to the skill level of those writing them. I think as an auditee that you have a burden of proof to show evidence that the people writing your internal procedures have adequate skills and training to write them correctly.

2. Varying Calibration dates. It is not acceptable to go past the calibration due date in my opinion (I will explain below). The only exception should be over a weekend when there is no production in progress. If due date is on a Saturday, it can be calibrated Monday, only if the unit can't be used between Saturday and Monday. The object is not to use past the due date, not for the unit to be calibrated by its due date. You can calibrate 15 days after the due date, but you have to prove that it could not have been used between. An example may be a log in system where you document on what date the unit was received in lab for calibration.

As for variability of the due dates, the calibration interval is the amount of time within which you have some defined level of expectation (percentage probability) that a given unit will remain in tolerance. If it is a 30 day interval. The definition is that you have some defined level of confidence that the unit will remain in tolerance for that 30 day interval (either the manufacturers prescribed interval, or a statistically derived probability based on prior history for calibrations). To arbitrarily add a plus or minus amount of time you need to give evidence that the higher interval is still adequate. For example you began with a 30 day interval and allowed 34 days maximum, what evidence can you give the auditor that the unit has the same statistical probability of being in tolerance at 34 days. I would say you can't do that, because statistically, by definition, for each day you add to the interval, your statistical confidence that the unit will remain in tolerance will decrease.

Enuff' said.

------------------
 
K

Ken K.

#13
Jerry, you brought up a point I might disagree with. I don't think this is the place to post this, but I'll take a chance.

You wrote;

"The only holes I believe an auditor could poke in internally written procedures is as to the skill level of those writing them. I think as an auditee that you have a burden of proof to show evidence that the people writing your internal procedures have adequate skills and training to write them
correctly".

Am I to beleive you feel an auditor can come into our(a)plant and question if the people doing certain jobs are qualified? Shouldn't the company, who put those people in their positions, determine if they are qualified or not? After all, if the company didn't think they were qualified, I don't think they would have hired or promoted them for those positions.

Sounds sort of scary to me.

Any thoughts on this?
 

Jerry Eldred

Forum Moderator
Super Moderator
#14
It seems that the debate here is 'common sense' versus 'what an auditor can manage to find wrong'.

Those two don't always seem to line up. The case in point is the discussion above wherein even though the company may well have had good procedures, the auditor seemed to find fault in the internally written procedures. In the common sense world, you hire good, qualified people to do their job (including write procedures). They write appropriate procedures, the procedures are approved within a good quality system, with good revision control, and properly adhered to. Trouble is, an external auditor can theoretically poke holes in that system. So one finds oneself creatinga system that is artificially 'better' to go above and beyond what works well for the company to the level of what additionally keeps the auditors happy.

I have been trained in a certified course as an ISO9000 lead auditor. But I have 23 years in metrology. And my experience has been that common sense (unfortunately) does not always rule. I am on your side, and theoretically don't at all disagree. The company should be able to make intelligent decisions as to what makes them able to produce consistent quality product. But my cynical side has also experienced the obverse - auditors that seem to come in and find holes in good systems (as well as miss holes in not so good systems).

My observations were aimed at attempting an answer as to where the auditor poked a hole in a good system, and how to satisfy the auditor.

My bottom line is, make and document a good system and follow it. Assure the system is adequate to assure the calibrations are performed correctly to subsequently assure product quality/integrity/reliability (which ever is applicable). When the auditors come (and they will in an ISO or QS type site), and poke holes in that good system, do within reason, what you have to to maintain that integrity, and correct the (albeit sometimes frivolous) audit discrepancy (non-conformance)).

------------------
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#15
Jerry's response was - right on the mark. Thanks for the detail, Jerry. I'm pretty shoddy with answers. I would have just answered YES and Yes it is scarry....

Originally posted by Ken K.:
Am I to believe ... an auditor can come into our (a) plant and question if the people doing certain jobs are qualified?

Sounds sort of scary to me.
My thoughts are, YES - It's quite true! You have to be ready to stand your ground!

When I first put this web site up over 4 1/2 years ago, I had learned 1 thing about ISO which was worse with QS. See Elsmar.com/entry2.html#original - it says:

Do You... Understand the Intent?
Are You... Ready to (Can You) Explain?


The 'game' had begun in ernest. As I have said many times in these forums, I tell my clients to be ready from the beginning to fight.

Again, this was written well over 4 years ago. The experience I was going through was the reason I put this site up back then! This thread, these forums, have evolved from those early pages and the trials at hand.

Some auditors are really good. Some are OK. Some are the devil incarnate. Things haven't changed all that much, either.

I still tell my clients at the first meeting:

You have to Understand every sentence of the document, the Intent of each sentence, and you have to be Ready to Explain how you meet the intent of each sentence! I can't explain for you... And - be ready to fight for your interpretation. You may have to.

As to the specifics of whether they can actually WRITE YOU UP for not having qualified people, you have to be ready to provide documented qualification requirements for the position (not to be confused with job criteria or job description elements) and be ready to discuss why those requirements are appropriate for the position - in case the auditor wants to push that far (which I have seen done many times, especially in QS audits).

Still scarry???

[This message has been edited by Marc Smith (edited 10 June 2000).]
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#16
Originally posted by Ken K.:
... brought up a point I might disagree with. I don't think this is the place to post this....
This is precisely the place to post what you posted!!!!! In many ways, it is the heart of this site!
 
K

Ken K.

#17
I sure wish I would have found this sight years ago. Marc, you should be proud of what you put together. Finally, a helpful sight without all the BS.
Yes, still scarry. Another audit in September. What surprises await?!
 

CarolX

Super Moderator
Super Moderator
#18
How can I access GIDEP? We are stricly a commerical house, and we do no business with the US or Canadian government. any suggestions?
 
K

Ken K

#19
I sent in my participation request/user authorization on 6/26/00 and am waiting for a reply. I work for a large automotive interior supplier which I hope will get us approved. Does the offer apply to everyone Jerry? I might also need some help if I am denied.
 

Jerry Eldred

Forum Moderator
Super Moderator
#20
Feel free to email me. I am on the road the rest of this week, and it will be the end of next week before I will be able to reply. But again, just ask via email, as I don't want to get that detailed in the forum. Send to [email protected]

------------------
 
Thread starter Similar threads Forum Replies Date
Crimpshrine13 Laboratory Scope - Calibration vs. Test Methods - IATF 16949 IATF 16949 - Automotive Quality Systems Standard 3
A Validation of Calibration Methods and Traceability - ISO 17025 ISO 17025 related Discussions 3
M Difference B/W Calibration Methods & SOPs General Measurement Device and Calibration Topics 4
S Mechanical/Electrical Forces Gage Calibration Methods Calibration and Metrology Software and Hardware 1
M pH Calibration - Comparing Electrical and CRM Methods General Measurement Device and Calibration Topics 1
R LCP 01201P and ICPF2P Calibration Methods Stated in Calibration Certificate General Measurement Device and Calibration Topics 2
6 Fuel Testing Laboratory Test Equipment - Methods and Calibration General Measurement Device and Calibration Topics 2
E AS9100 Equipment Calibration Recall Methods and Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
P Micrometer Calibration Methods Calibration Frequency (Interval) 11
M Methods for Verification/Calibration of Video (Optical) Extensometer General Measurement Device and Calibration Topics 2
M Old calibration standard methods - Question for ISO 17025 auditors..... ISO 17025 related Discussions 1
R Standard Methods - Internal Calibration Laboratory - What if there is no standard? IATF 16949 - Automotive Quality Systems Standard 2
M Laboratory Statistical Methods and the Calibration Laboratory General Measurement Device and Calibration Topics 1
R Methods of Reviewing Calibration Intervals Calibration Frequency (Interval) 2
P Calibration Stickers or Other Methods of Identifying when Gages are Due? General Measurement Device and Calibration Topics 32
lanley liao Question regarding the calibration of monitoring and measure equipment. Oil and Gas Industry Standards and Regulations 0
N IATF Calibration Lean in Manufacturing and Service Industries 4
Q Do these certificates of calibration meet ISO 9001 requirements for traceability to NIST? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
T Plug Gage Calibration Calibration and Metrology Software and Hardware 1
M Load Cell Calibration using a totalizer on a flow meter General Measurement Device and Calibration Topics 0
E Calibration Records needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
D Limited Range Calibration - 5000 lb Industrial floor scale General Measurement Device and Calibration Topics 3
D Calibration of Small Scales General Measurement Device and Calibration Topics 26
C How to Establish the Calibration & Measurement Capability (CMC)? ISO 17025 related Discussions 1
I IQOQ or just initial calibration required? General Measurement Device and Calibration Topics 3
B Calibration in real life ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
J Calibration cycle for monitoring & measuring tools used in medical device manufacturing General Measurement Device and Calibration Topics 5
A Is calibration of test weight required General Measurement Device and Calibration Topics 4
S Calibration Frequency for Slip Gauge Kit used for CMM Calibration? General Measurement Device and Calibration Topics 0
S Calibration/Verification of customer fixtures IATF 16949 - Automotive Quality Systems Standard 6
Ron Rompen Calibration by manufacturer ISO 17025 related Discussions 4
Q Calibration verification records 7.1.5.2.1 IATF 16949 - Automotive Quality Systems Standard 2
B AS9100D 7.1.5.2 Calibration or Verification Method using outside cal lab AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
W Next Calibration Due Date Calibration Frequency (Interval) 5
S Where do l get calibration standards to run a calibration lab? Other ISO and International Standards and European Regulations 2
A OEM On-Site Calibration issues during Covid19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
D Calibration tolerance question using Pipettes Medical Device and FDA Regulations and Standards News 1
M Calibration Certificate Result issued by an accredited external laboratory General Measurement Device and Calibration Topics 9
G Calibration of "Master Parts" Used as Gauges Calibration Frequency (Interval) 5
R Calibration lab environmental monitoring General Measurement Device and Calibration Topics 4
G Calibration of Rotronic probe but not digital readout? General Measurement Device and Calibration Topics 3
F Standard Calibration Procedures: Recommended Practice ISO 17025 related Discussions 0
T Temperature Requirements For In House Calibration - AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
B Gage calibration frequency, ISO and IATF - What are the requirements Calibration Frequency (Interval) 3
Crimpshrine13 Calibration of pH Meter Probe Calibration and Metrology Software and Hardware 3
F ESD workbench "calibration" Manufacturing and Related Processes 2
C Correct Calibration Method for Dial Depth Gage General Measurement Device and Calibration Topics 6
F Nist traceable calibration certificates General Measurement Device and Calibration Topics 1
G Tool tracebility and First calibration requirements for aerospace (AS9100) organisation AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
D Calibration of Digital thermometer with surface probe General Measurement Device and Calibration Topics 1

Similar threads

Top Bottom