Need to convert Reference Only M&TE to a calibration schedule

#1
Our company is in the process of becoming certified to ISO 9001:2015. In an internal audit we discovered we use a large number of "Reference Only" measuring and test equipment (M&TE) to inspect and approve final product. The M&TE were designated "Reference Only" by a previous QC Manager because they are sparsely used, and to reduce calibration costs. However, as I have learned, the general rule of thumb is to place M&TE used for inspecting and approving product on a calibration schedule to ensure their continued accuracy.

My questions are:
Do certain M&TE not require calibration/verification (e.g., pin gages, thread pitch gages)?

Is a 5 year interval too long for a device used an average of 2 or 3 times yearly? Is there an accepted standard for setting intervals?

What types of M&TE can be designated "Calibrate before use"?
 
Elsmar Forum Sponsor

howste

Thaumaturge
Trusted Information Resource
#2
re: Need to convert Reference Only M&TE to a calibration schedule

My questions are:
Do certain M&TE not require calibration/verification (e.g., pin gages, thread pitch gages)?
No.

Is a 5 year interval too long for a device used an average of 2 or 3 times yearly? Is there an accepted standard for setting intervals?
Your company needs to understand and accept the risks. If at the end of a 5-year cycle you find that the equipment is out of tolerance, what would that mean in terms of nonconforming product shipped? You don't know when it went out. Is your company willing to deal with the consequences?

What types of M&TE can be designated "Calibrate before use"?
As far as I know, any equipment can be designated as calibrate before use. If you're not using the equipment then there's no risk of a bad measurement. Just make sure that you have the ability to calibrate/verify it in time so it doesn't impact schedules.
 
#3
re: Need to convert Reference Only M&TE to a calibration schedule

We have a large amount of RO measurement tools on the floor, BUT, final inspection uses calibrated tools only, this is how we reduce calibration costs. Some is marked "CBU" but we have the ability to calibrate it as needed, as it is rarely used.
 

BradM

Staff member
Admin
#4
re: Need to convert Reference Only M&TE to a calibration schedule

To add to the other good responses.. the problem is. you don't have any history on these instruments. You don't know how they will perform.

Many times (not the norm) companies have a lot of instruments; many times more than their current processes dictate. I would first assess what you really need and which ones are going to be critical; need to be calibrated.

Then, I would take a sample of those and send for calibration. Before you spend too much time and money in enrolling them in a program and such, make sure they will pass calibration.

Like Howste stated, it really depends on a lot of factors as to how often you should calibrate. For starters, how often they are used, your risk, the instruments themselves. Saying... I personally set a much longer interval on a Fluke multimeter than say... an ABC cheapy meter I know nothing about. :)

So first, I would assess what equipment requires calibration, assume an annual calibration, determine annual cost and inform management as a start.
 
Thread starter Similar threads Forum Replies Date
R Need help on calibration result analysis Measurement Uncertainty (MU) 11
M Do i need to have equipment validation if 100% testing is completed? Qualification and Validation (including 21 CFR Part 11) 4
G Need Help with Run @ Rate for Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 0
F Need help in IMS management review Management Review Meetings and related Processes 3
S I need help in corrective action plan Nonconformance and Corrective Action 15
A Do clinical performance studies for IVDs need to be conducted in a member state? EU Medical Device Regulations 2
A Do clinical performance studies for IVDs need to be conducted in a member state? CE Marking (Conformité Européene) / CB Scheme 0
D Weird spec sheet - need help Measurement Uncertainty (MU) 3
E Do I need test reports for all standards mentioned in my 510k application? Other Medical Device Related Standards 8
J Japan registration need manual without temperature reading Japan Medical Device Regulations 0
Ashland78 Need IATF 16949 ISO Gap Analysis Excel File Internal Auditing 3
R Need for an Importer outside EU? EU Medical Device Regulations 0
T Do I need to add non-product related service providers to my ASL? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
K Need Help With Auditing Suppliers Against ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 50
A Need career advice on QMS & HSE (No hands on experience) Career and Occupation Discussions 6
B Need assistance with documents CE Marking (Conformité Européene) / CB Scheme 2
R Lead auditor scenario (Need help) is this non conforming to ISO13485 Manufacturing and Related Processes 2
Ashland78 Need to show evidence in accordance with QR-11012 and SPB-00001-09 Customer and Company Specific Requirements 5
E Does IVD need to integrate with hospital IT infrastructure? Medical Information Technology, Medical Software and Health Informatics 2
U Need Help With API Q2 Quality Manual Oil and Gas Industry Standards and Regulations 8
S In Need of GIDEP Guidance AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
M Do employee training records need to be controlled documents? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
D What evidence to I need to supply as a remote location in relation to manufacturing sites? IATF 16949 - Automotive Quality Systems Standard 10
T Non API products need to comply to API Q1? Oil and Gas Industry Standards and Regulations 3
G Need journal and reference of abnormal bar chart SPC Statistical Analysis Tools, Techniques and SPC 4
MSeibert47 Daily Quality Topics - Need Ideas Please! Food Safety - ISO 22000, HACCP (21 CFR 120) 18
W Do Reference materials for IATF need to be 17025? IATF 16949 - Automotive Quality Systems Standard 15
D Need some Help on 8D fault tree analysis Problem Solving, Root Cause Fault and Failure Analysis 6
A Need to calculate tolerance Intervals with a set of non-normal data and 3-Parameter Weibull distribution Using Minitab Software 0
Melissa Risk Management Process, How far do I need to go? ISO 14971 - Medical Device Risk Management 13
F Need Quality Manager advice. Quality Manager and Management Related Issues 6
T Do we need an SOP for ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
B Do CTQs need to be equipment specific? FMEA and Control Plans 8
K Do Contract Manufacturers need a complaint procedure? Medical Device and FDA Regulations and Standards News 10
K Screen printing ink and machine selection_ Need help Manufacturing and Related Processes 6
D Do employee training records need to be centralized? IATF 16949 - Automotive Quality Systems Standard 10
H Need of EU Representative Designation for Turkey? EU Medical Device Regulations 3
H If we use agile - do we still need to document TF as a waterfall just for the notified bodies need? IEC 62304 - Medical Device Software Life Cycle Processes 2
briteme4 AS9102 First Article Inspection - do I need a second reviewer and signer? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
J Furnace repaired - Do I need a new initial TUS? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 1
S Need ISO 15189:2012 Documentation toolkit. Document Control Systems, Procedures, Forms and Templates 0
J Need a contract monitoring Tool General Information Resources 0
P UDI-PI requirements on reusable surgical device, do we need serialisation? ISO 13485:2016 - Medical Device Quality Management Systems 3
J Need Help with FPY Data in Assembly Process Manufacturing and Related Processes 7
W 17025 and NIST handbook relationship (need advice) ISO 17025 related Discussions 8
lanley liao Does all of the suppliers need to integrated into the supplier list qualified of the company? Oil and Gas Industry Standards and Regulations 2
K Need procedure for D&D inputs? ISO 13485:2016 - Medical Device Quality Management Systems 4
S Need help on "Country of Origin" Medical Device and FDA Regulations and Standards News 0
Ed Panek Immediate need for 80601-2-56 Consulting expert. PM me for details Career and Occupation Discussions 0

Similar threads

Top Bottom