Calibration 4.11 2c - Defining acceptance criteria for all equipment

W

Wendell Goodson

#1
Question?

Our Third party registrar LRQA has stated that we (my company) must define
the acceptance criteria for all equipment, in other words, define the actual
criteria for the standards to be used to such as the tolerance on the gauge
blocks that is to be used to calibrate a micrometer.

4.11.2 Control procedures
The supplier shall: c) define the process employed for the calibration of inspection, measuring, and test equipment, including details of equipment type, unique identification, location, frequency of checks, check method, acceptance criteria, and the action to be taken when results are
unsatisfactory;

We use an outside certified laboratory to perform our calibrations on items
such as scales, surface tables, and measuring instruments.

How are other companies doing this? I've never had to do this with DnV or ABS, is this just a LRQA requirement? I've always used a certified laboratory and placed their internal procedure on the purchase order, and
required that the out-of-tolerance be no more than 50% of the accuracy of the instrument without adjustment, (which is in our procedures and on the PO) and if out more than allowed by the instrument measuring accuracy the sub-contractor is required to report and state any adjustment they took and we will do all necessary corrective action inside to prevent our customers from receiving nonconforming
product. For those that want the response from LRQA let me know, "oh" Heck, I'll place it with this.

Regards

Wendell Goodson

LRQA's Response:
I have received your Email of today concerning LRQA's interpretation of
calibration controls.

I have not seen any paperwork from a visit to know the specifics but I can give
general comments, using a micrometer as an example.

1. You must define the acceptance criteria for the devices. We have seen
companies state the tolerances and method of calibrating, specifically call for
a specification (example ASTM) which gives method and tolerances or call for
another specification (such as your calibration lab's procedure which gives
method and tolerances).

2. If you accept a calibration lab's procedure and tolerances, you should have
a copy of it available to you to know what you are accepting. The tolerance
must be known as you accept the results of the external laboratory. You can
accept the work of the lab not subcontract the acceptance of the results.

3. When found to be out of your defined tolerance, a documented assessment of
the validity of previous inspection and test results must be performed
(4.11.2.f).

I hope this helps a bit. I can not give consultancy but you will have my email
address on receipt of this message and with more information, I can possibly
clarify some issues. The phone number is 281-398-7370 ext 211.


Richard Gensmer
Operations Manager.
 
Elsmar Forum Sponsor

Marc

Fully vaccinated are you?
Leader
#2
This level of detail expected is another pass-over from QS-9000. UL started pushing this a few of years back. Not so long ago the 'standard' was "...Is your equipment calibrated?" This served well for many if not most companies. However, failure investigations showed that this was insufficient for many companies. I fell to the old notion and at first, in fact, resisted this new 'level of understanding' as most of my clients had an internal person who understood measurement systems analysis. Many companies, however, did not have anyone who actually understands the entire concept. QS9000 addressed the issue with their requirements.

Registrars have been increasingly enforcing, if you will, the requirement details. QS registrars, back when QS came out, were only interested in whether you had a solid calibration program but pretty much limited their questioning to "...Is your equipment calibrated?" As time passed UL was first to really 'put the screws' to companies doing the QS dance to comply with the higher requirement of, well, having a good understanding of all the details involved.

As I said, I first resisted this tightening of the requirement, so to speak.

This evolution could be followed in Greg Gogates wonderful list-serve as more and more suppliers of calibration services were bombarded with 'requirements' from their customers (particularly QS customers). Discussions included all the extra work involved. Some discussions centered about costing and the neccessity to increase fees as more and more customers asked for copies of calibration procedures. In addition, a chorus was heard from cal services suppliers wherein they charged that many customers were, in fact, quite ignorant of the overall process including their specific needs. The 1998 revision of QS caused a real commotion and, as many here found, they could not even find a supplier of cal services who were compliant to guide 25 or whatever.

In all this what we see is an evolution of the requirement to calibrate M&TE to a requirement that someone in a company understand the whole of the situation.

In all this is needed, I now admit. Enforcement has evolved as well. This might in part be due to the lack of understanding of measurement systems analysis by the auditors themselves. But this goes into an often observed ignorance of so many auditors of what they are auditing - which I won't pontificate on right now.

It appears you are complying to LRQA's response #1. Response 2 is pretty self explainatory and it appears you comply with response 3.

Now - did the auditor say you are not in compliance? If so, what specifically?
 

Marc

Fully vaccinated are you?
Leader
#3
For those of you not following Greg's List serve:

To: iso25
Subject: Re: 4.11 2c RE4

In a message dated 6/26/00 2:06:16 PM Pacific Daylight Time, XXXX writes:

<< My Question is: How can a company like GTM Plastics specify a standard to
>be used in calibration of an instrument such as a CMM?

ANSI/ASME B89.4.1 - 1997 is the standard you are looking for. >>

Or, if you prefer, you can ask that it be measured in accordance with ISO 10360-2.

Ralph C. Veale
408 Orlando Avenue #10 A
Ocoee FL 34761
 

Marc

Fully vaccinated are you?
Leader
#4
And:

Date: Mon, 26 Jun 2000 14:45:44 -0400
From: Philip Stein <[email protected]>
To: Greg Gogates <[email protected]>
Subject: Re: 4.11 2c RE3

Response to

>
>From: Wendell Goodson <[email protected]>
>To: Greg Gogates <[email protected]>
>Subject: 4.11 2c

>However, we use an outside calibration service to conduct the calibration on
>our surface plates, CMM, and other instruments that we do not have the
>capability or the environment to perform this type calibrations. We are very
>careful in our selection of our calibration services ensuring that they are
>a certified lab and ISO-9002 certified.
>
>My Question is: How can a company like GTM Plastics specify a standard to
>be used in calibration of an instrument such as a CMM?

ANSI/ASME B89.4.1 - 1997 is the standard you are looking for.

>We see the
>calibrations Labs procedures and call it out on the Purchase Order to them,
>however we do not have the slightest idea of the tolerance used to
>manufacture this standard. What good are the labs if the certification to
>A2LA or ISO. This is not value added. We always put in the Purchase Order
>to the Lab a requirement to notify GTM when the instrument is out of
>tolerance or when there is adjustment. There is not a calibration laboratory
>in the country that will part with the individual procedures, their QA
>Manual yes but not the individual procedures.

There are quite a few labs that will share their procedures. Many of
them are public, and are published by GIDEP, NavAIR, etc.
 
Thread starter Similar threads Forum Replies Date
D Defining ISO17025 Calibration Laboratory Technical Competency ISO 17025 related Discussions 1
D Internal Laboratory - Defining the Laboratory Scope - Inspection, Test, Calibration Inspection, Prints (Drawings), Testing, Sampling and Related Topics 18
D Roughness specimen calibration Calibration and Metrology Software and Hardware 5
dhuot1990 General Calibration SOP Manufacturing and Related Processes 3
B Gage calibration Gonogo (calcul of cgk) General Measurement Device and Calibration Topics 0
Vader22 As-Found FAILED calibration ISO 14001:2015 Specific Discussions 16
M Gravimetric blender for resin in automotive industry - periodical calibration via external lab with certification Reliability Analysis - Predictions, Testing and Standards 0
N Calibration Method for Scales and Flowmeters Reliability Analysis - Predictions, Testing and Standards 7
T Calibration Tracking ISO 13485:2016 - Medical Device Quality Management Systems 4
Q Considering addition of mass calibration to ISO17025 scope ISO 17025 related Discussions 6
Z Resolution in calibration General Measurement Device and Calibration Topics 1
J Run Down Adapters Calibration Processes General Measurement Device and Calibration Topics 4
S Looking for accredited calibration lab - Onsite up to 650A and 1 kV. General Measurement Device and Calibration Topics 3
CaliperJim Screw Thread Micrometer Anvil Calibration General Measurement Device and Calibration Topics 7
Strange Juan HP 85054B Standard Mechanical Calibration Kit Calibration Procedure General Measurement Device and Calibration Topics 1
H Air Pressure Gage Calibration General Measurement Device and Calibration Topics 6
T Calibration on AVL AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
C Determining an as received OOT condition during calibration does not affect measurements taken prior to calibration. General Measurement Device and Calibration Topics 16
Sam.F Do heat treatment ovens need calibration? General Measurement Device and Calibration Topics 22
J Selecting reference standards for calibration General Measurement Device and Calibration Topics 3
C IATF 16949:2016 Major NC pertaining to 7.1.5.2.1 Calibration/verification records IATF 16949 - Automotive Quality Systems Standard 15
E Calibration Records during AS9100 Audit AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
John Predmore Calibration Determination decision Calibration Frequency (Interval) 15
J ISO 17025 Calibration Other Medical Device Related Standards 2
A Electronic Weighing scale calibration Calibration Frequency (Interval) 4
M Bourdon gauge calibration procedure failure ISO 17025 related Discussions 3
Ed Panek Calibration question Manufacturing and Related Processes 4
S Calibration/Worn gages Manufacturing and Related Processes 9
A Settings rings calibration General Measurement Device and Calibration Topics 4
R 7.1.5.2 -- Calibration AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
C CALIBRATION CERTIFICATE REQUIREMENTS General Measurement Device and Calibration Topics 11
S Calibration Label issues General Measurement Device and Calibration Topics 21
H Calibration / Capability in a PCP FMEA and Control Plans 1
R First Time Managing Calibration and Measurement System. Need Help. General Measurement Device and Calibration Topics 19
M CE marked medical device - do they need UKAS certified calibration provider ISO 17025 related Discussions 4
JDJohnson Micrometer & Caliper Calibration (ISO-9001) General Measurement Device and Calibration Topics 26
B Precision Current Loop for Current Probe Calibration Reliability Analysis - Predictions, Testing and Standards 2
Strange Juan Freezers fridges Incubators Calibration Labels General Measurement Device and Calibration Topics 12
D Tolerance and MPEs for Re-calibration Manufacturing and Related Processes 0
D ISO 9001:2015 Calibration Procedures Manufacturing and Related Processes 16
G Calibration of Angle microscope stage micrometer General Measurement Device and Calibration Topics 1
K END CALIBRATION CANNOT BE PERFORMED Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
C Gage Block Grade 1 - Calibration Measurement Uncertainty (MU) 15
JoeRandom11 Question of Calibration Cycles AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
placebo_master What is the difference between "Fitness for Purpose" and "Calibration/Verification"? General Measurement Device and Calibration Topics 6
G AMS 2750 F Instrument Calibration Results and Recording AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
Q Gage calibration in disarray ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
R GearBox Test Bench Calibration General Measurement Device and Calibration Topics 2
Q Internal calibration (stopwatch) IATF 16949 - Automotive Quality Systems Standard 3
D Is calibration really required? IATF 16949 - Automotive Quality Systems Standard 6

Similar threads

Top Bottom