ILC/PT for 25% of the testing listed in their lab scope for Type A Tests

K

Ken K

#1
Proficiency TEsting

It is recommended that accredited labs perform ILC/PT for 25% of the testing listed in their lab scope per year. My question is how do you handle this for Type A tests?

Category A Testing Defined

Qualitative tests are test for which there are no quantitative results.

For example:

-- Go-no go tests.
-- Tests where results are a comparison form a reference plaque; such as, Microstructure ASTM A247, Degree of Blistering ASTM A247, Inclusion Content ASTM E45
-- Tests where the result is numerically rated by judgment; such as, Tape Adhesion ASTM D3359.
-- Tests that are exposure or environmental simulation only; such as, Salt Spray ASTM B117, Xenon Arc SAE J1885 and J1960, Environmental Cycles GM 9505P.

Almost 60% of the tests listed in our scope are category A.

Any help would be appreciated. :confused:
 
Elsmar Forum Sponsor
T

tomvehoski

#2
I had a similar situation with a scale calibration company. Our situation was that it was not possible to send a scale to multiple companies since calibration could be altered in shipping. It was also not acceptable to my client to have his competitors come into his shop to do a test on site.

I can't remember if the intrepretation came from LAB or NIST, but basically I was told that an independent audit by a qualified person witnessing the test in question can be considered a proficiency test. Our 3rd party ISO 17025 auditor fulfilled this requirement when he performed the certification audit. He was not sure if he could accept that until I showed him my correspondence e-mails. I will see if I can dig up my records if you think this will help.

Tom
 
G

Graeme

#3
Follow the numbers?

Ken K said:
It is recommended that accredited labs perform ILC/PT for 25% of the testing listed in their lab scope per year. My question is how do you handle this for Type A tests? ... Qualitative tests are test for which there are no quantitative results.
Ken,

Many of the tests you mention are based on quantitative values, even if the testing lab does not measure or report the numbers directly. For example, of the tests I am directly familiar with,
  • Go/no-go tests often use a gage that must meet dimensional specifications.
  • Enviromental effects tests are based on actual measurements of temperature, relative humidity, absolute air pressure, water salinity or other factors.

A question for you and the assembled gurus is,
IF a testing lab performs the base physical, dimensional or electronic measurements AND is accredited in those measurement areas, THEN can they say that the derived qualitative tests and results are accredited?

For example, assume that a testing lab routinely makes measurements of temperature using a PRT sensor, and relative humidity using a chilled-mirror standard. Also assume that the lab is accredited in those two areas over some range of values, and participates in proficiency tests of those parameters. My question is asking, I think, is that accreditation still valid when the measurements are made inside a temperature-humidity test chamber, with the measurement results used as immediate feedback to modulate the operation of that chamber? If not, then what is the key difference?

If such a scenario would be acceptable then the course of action seems to be to obtain proficiency tests and become accredited in the actual measurement parameters that form the foundation of the qualitative tests. Of course, this still would not work for some things, especially those that rely on judgement and/or human comparison to a visual (or other) reference artifact.
 
K

Ken K

#4
Thanks for your responses. I guess I need to explain the situation a little more.

We will be required to participate in two major ILC/PT per year, and preferably 25% of our scope per year. The major's I have no problem with.

My problem is how to do ILC/PT with a Hot Odor test such as
SAE J1351 for example. And how would you judge if the results were acceptable for a PT?
 
G

Graeme

#5
Ken K said:
My problem is how to do ILC/PT with a Hot Odor test such as
SAE J1351 for example. And how would you judge if the results were acceptable for a PT?
Ken,

My previous response was based on the examples in your list that I am familiar with. While I have smelled some hot odors (if you are driving on I-285 at I-675 during the summer ...pheww!) I am not at all familiar with the SAE spec.

Have you tried benchmarking oustide your industry for ideas? Odor is an important characteristic of many cosmetics, for example. Also, there must be some medical protocols involving odor. Possible these or other areas coud give some ideas ...

Graeme
------------------
Clueless in Atlanta
 
Thread starter Similar threads Forum Replies Date
F Measurement Audit and ILC for ISO 17025 Clause 7.7.2 - Comparison with results of other laboratories ISO 17025 related Discussions 0
P Alternative To PT/ILC (Inter-Laboratory Comparison) Requirement General Measurement Device and Calibration Topics 3
J PT/ILC - No Approved Programs within our Scope of Accreditation General Measurement Device and Calibration Topics 2
Hershal PT/ILC - ISO 17025 section 5.9 - Proficiency Test/Inter-Laboratory Comparisons ISO 17025 related Discussions 27
K When is Bioburden Testing Required? Other Medical Device Related Standards 3
K IEC 62304 - Testing Independance IEC 62304 - Medical Device Software Life Cycle Processes 5
A ANSI/AAMI versions of 60601-1-2 and related testing requirements Other Medical Device Related Standards 0
C Surgical mask stability testing (CE mark) EU Medical Device Regulations 1
Beliz Biocompatibility Testing for Laser Epilation Device EU Medical Device Regulations 2
C One Time Service Supplier - Temperature and Humidity Testing Service ISO 13485:2016 - Medical Device Quality Management Systems 5
D IEC 60601-1 - Service life testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
P Flammability Testing of Aircraft Interior Materials Federal Aviation Administration (FAA) Standards and Requirements 0
N Usability testing required for FDA IDE (investigational device exemption)? Human Factors and Ergonomics in Engineering 3
E ASTM F2118 - Fatigue testing of bone cement - Changes between the 2003 and the 2014? Other Medical Device Related Standards 1
K Biocompatibility Testing - Multile products of different sizes and shapes US Food and Drug Administration (FDA) 2
S Requirement to Conduct New Shelf-life Testing? (re-do testing for design change) EU Medical Device Regulations 3
JoCam Mobile Patient Hoists and Electrical Testing Other Medical Device Related Standards 0
T Interlaboratory comparison or proficiency testing in destructive testing of welded joints ISO 17025 related Discussions 2
B ASTM E18-2020 - Rockwell testing standard changes? General Measurement Device and Calibration Topics 2
U Medical Device Design finalization testing ISO 13485:2016 - Medical Device Quality Management Systems 2
Jane's Like-for-like critical raw material change qualification - type of testing/ number of lots required ISO 13485:2016 - Medical Device Quality Management Systems 4
J Conflict of Interest Registrar/Notified Body/Testing House Quality Manager and Management Related Issues 4
M Inter-operator Variability Testing - Requirements for EU Medical Device Regulations 5
S High voltage testing - ISO 17025 - 7.2.2 Validation of methods and 7.3 Sampling ISO 17025 related Discussions 3
M Production approval testing - Alternative ideas for Validation Reliability Analysis - Predictions, Testing and Standards 4
JoCam MDL in Canada without Canadian Electrical Testing Canada Medical Device Regulations 0
T HF testing / Summative evaluation for MDDS class I necessary? Human Factors and Ergonomics in Engineering 2
Kuldeep Singh Diagnostic X-ray devices - Applicability of Biocompatibility Testing per ISO 10993-1 Manufacturing and Related Processes 7
K Proper document of SMPS used in infant warmer for IEC 60601-1 testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
K Sequence of testing in IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
M Workplace Drug Testing in 2020 Misc. Quality Assurance and Business Systems Related Topics 9
W ASTM F1929 dye penetration test - Validation for in-house testing ISO 13485:2016 - Medical Device Quality Management Systems 13
J FDA wants electrical safety testing on battery powered medical device US Food and Drug Administration (FDA) 11
S Internal calibrations - Part of an ISO 17025 accredited testing laboratory (Automotive) ISO 17025 related Discussions 3
T Qualification testing of Lead acid batteries Reliability Analysis - Predictions, Testing and Standards 0
D Sterility and BioBurden Testing for Plastics ISO 13485:2016 - Medical Device Quality Management Systems 5
DitchDigger IEC 60601-1 subclause 5.1 - Adequate evaluation in lieu of testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
E Correct way to certify hydrostatic testing when it is not 100% (and Sample Size) Various Other Specifications, Standards, and related Requirements 6
MrTetris Are GLP required for testing cytotoxicity and soil remaining after sterilization of MD? Other Medical Device Related Standards 8
D Design Verification - Is testing required? Design and Development of Products and Processes 5
M Specific Absorption Rate (SAR) Testing - What Standard to Use? Other ISO and International Standards and European Regulations 1
N IATF 16949:2016 7.1.5.3.2 External Laboratory - How to approve the Testing Laboratory without accreditation scope IATF 16949 - Automotive Quality Systems Standard 2
T Spirometer - Pulmonary Function Testing - ATS/ERS:2005 EU Medical Device Regulations 5
M 510(k) 10993 Biocompability Testing Other US Medical Device Regulations 15
C Sterility and Bioburden Testing - LAL passed under 0.5EU/mL Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
A ISO 17025 Requirement 6.2 - Department Manager Testing Qualifications ISO 17025 related Discussions 1
P IEC 62304 - evaluation of integration and system testing IEC 62304 - Medical Device Software Life Cycle Processes 4
H EO Sterilization Validation - Sterility Testing and Load Configuration Other Medical Device Related Standards 1
M What to do in SOP Phase of Head unit testing? IATF 16949 - Automotive Quality Systems Standard 0
W SOP examples wanted - Soil, Concrete and Asphalt testing ISO 17025 related Discussions 3

Similar threads

Top Bottom