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

Hunkered Down for the Duration
Staff member
Admin
#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

Hunkered Down for the Duration
Staff member
Admin
#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

Hunkered Down for the Duration
Staff member
Admin
#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
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
T Calibration or Verification -> Cm and Cmk, etc. Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
Q Quality Technician (calibration / metrology) - Memphis, TN Job Openings, Consulting and Employment Opportunities 1
G Is repeatability required for equipment calibration? General Measurement Device and Calibration Topics 10
was named killer AS 9100D - Calibration Instructions - Controlled documents? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
B Photovoltaic Tester Calibration General Measurement Device and Calibration Topics 0
B Temperature loop: partial calibration General Measurement Device and Calibration Topics 10
G Glass scale calibration at 74 degrees F? General Measurement Device and Calibration Topics 4
A Digital Timer Calibration Requirements General Measurement Device and Calibration Topics 3
Ron Rompen Barcode Verifier Calibration and Use Calibration and Metrology Software and Hardware 5
S Is Optical Parallel Set required calibration? ISO 17025 related Discussions 1
A Calibration of Power Supplies AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
D Calibration Process Flow Map Example Wanted General Measurement Device and Calibration Topics 3
M Calibration or Verification? What terminology to use ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
N Calibration Requirements for Production Equipment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
S Calibration Equipment Selection General Measurement Device and Calibration Topics 2
D Sample Calibration SOP for ISO 13485 General Measurement Device and Calibration Topics 4
L Calibration of Plug Gauges - Tolerancing General Measurement Device and Calibration Topics 1
L In house calibration - Our CMM's are outside certified can I use them to certify our standards General Measurement Device and Calibration Topics 4
R Standard Filter for Calibration Colorimeter ISO 17025 related Discussions 1
J Documenting a Calibration Interval Extension Calibration Frequency (Interval) 7
F Calibration certificate content - Average Value and True Value ISO 17025 related Discussions 6
B Oscilloscope - AC gain calibration General Measurement Device and Calibration Topics 6
G Is it common to do a repeatability check during calibration of an instrument? General Measurement Device and Calibration Topics 5
A Adjustment of Calibration Intervals (Shortening or Lengthen) Calibration Frequency (Interval) 6
A Calibration required by OEM General Measurement Device and Calibration Topics 2
S ISO17020 - Equipment calibration requirement General Measurement Device and Calibration Topics 3
H Can a calibration lab still use ISO 6789:2003 as guide for torque calibrations Other ISO and International Standards and European Regulations 1
H Calibration of InfraRan Vapor Analyzer - where to get calibration for SF6 General Measurement Device and Calibration Topics 2
M How to read a calibration certificate for thermo hygrometer General Measurement Device and Calibration Topics 2
L Calibration Frequency for Surftest SJ-400 General Measurement Device and Calibration Topics 0
C External Laboratories and OEM Calibration IATF 16949 - Automotive Quality Systems Standard 0
V Ammeter calibration - Measuring head (on pic.) problem General Measurement Device and Calibration Topics 1
F How many signatures do we need on calibration certificates? ISO 17025 related Discussions 8
V Calibration certificate verification Qualification and Validation (including 21 CFR Part 11) 3
F Online courses - Metrology, standardization, calibration and ISO 17025 Training - Internal, External, Online and Distance Learning 3
A Calibration Certificate Results General Measurement Device and Calibration Topics 3
K ISO 17025:2017 clause 7.6.2 - Performing calibration of its own equipment shall evaluate the measurement uncertainty ISO 17025 related Discussions 6
G Third party auditor mentions no grace period for calibration Calibration Frequency (Interval) 22
E Calibration Certificate Content Requirements General Measurement Device and Calibration Topics 3
Casana IATF 16949 7.1.5.3.2 External Laboratory - On Site Calibration IATF 16949 - Automotive Quality Systems Standard 8
Nicole Desouza AS9100D - Calibration of Dies & Tooling - Plastic Extrusion AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
D Determining Calibration Frequency schedule for items used in production Manufacturing and Related Processes 2
WEAVER Electronic Weighing Scale Calibration Tolerance Manufacturing and Related Processes 1
I What kind of information needs to be in a calibration record? General Measurement Device and Calibration Topics 25

Similar threads

Top Bottom