SBS - The Best Value in QMS software

Personal Gages - Do they have to be calibrated and traceable?



Paersonal own gages such as set up do they have to be calibrated and tracable per qs-9000 standards. I have heard so many different stories,
Elsmar Forum Sponsor

Jim Biz

There are a number of threads here discussing pros & cons of the issue.

What happens here in our ISO-9002 system is "yes" we treat personally owned measurement equpt just like any other gage - the only difference is that we identify them by operator clock number....


[This message has been edited by Jim Biz (edited 23 June 2000).]

Jerry Eldred

Forum Moderator
Super Moderator
I think the main issue is that you have to have control such that regardless of whether a tool/gage is personal or company owned, you know that only properly calibrated instruments can be used in any place where it can affect product quality or reliability.

In the case of personally owned gages, some companies take the route that they are not allowed on premises. This is a simple solution, but sometimes not practical. Some other companies allow personal gages, but require that they be placed on the calibration recall system the same as company owned gages.

Either way is okay as long as you KNOW (not pretty sure, but KNOW) that ONLY properly calibrated gages/tools can be used as above. You have to be able to guarantee that product measurements meet the required accuracy. And whether personal or company owned, you MUST have unique identification of some sort that unambiguously enables the user to know the current calibration status of each specific gage/tool.

You will of course meet with the individual personal bias and prejudice of individual auditors, so that a perfectly satisfactory methodology will seem to be unsatisfactory in the view of some auditors.



Super Moderator
Super Moderator
One option that was not brought up was to clasify all personal owned gages shall not be used for acceptance of product. This is the rout we take with "functional gages" and with the inexpensive plastic calipers that are available. But since our personal owned gages, such as dial calipers, are used by production personnel for accepting product, the calipers are part of the caliration and recall system.

Jerry Eldred

Forum Moderator
Super Moderator
I tried to be deliberately a little vague on this, as I know there are many variations in industry. I did attempt to stick with the central issue, which is assuring that product be tested ONLY with properly calibrated instruments, which are adequate for the intended use.

In the case of marking personally owned gages as "do not use on product", I won't try to adjudicate whether or not that is acceptable, as that's not my place. I think that enters a grey area (depending on the particular company), and on some of the specifics.

There are cases where I think it questionable as to whether that method is prudent, and others where it would not be an issue. If there are personally owned gages that closely replicate calibrated production gages (similar accuracy, range, etc.), and the personally owned gages are used in a production area, it may pass the audit, and it may not. In such a case, one could envision an auditor querying as to why two similar gages are in the production area, and how the factory could guarantee those uncalibrated units would never be used to verify product. In such a circumstance (as an example; or similar), I would recommend against such practice. It would also become confusing, and you may have to show evidence that production pepole are trained as to which ones to use, and when.

The other end of the spectrum would be gages that are self-evident to not apply to product test, and/or which are used in areas where the potential ambiguity does not exist.

And 'ambiguity', I think is the operative word in determining if employee owned gages could be labelled as 'do not use for production' or not. If it creates a reasonable ambiguity, I don't think it wise to place uncalibrated gages in production. I could envision in such an ambiguous circumstance, a diligent auditor putting a great deal of effort into proving one way or the other as to whether evidence exists that those uncalibrated gages could have been used on product or not.

Okay... enough said.

Thread starter Similar threads Forum Replies Date
L Personal Gages and Calibration - Mold department uses personal gages in some aspects General Measurement Device and Calibration Topics 6
P MDR PRRC (person responsible for regulatory compliance) and personal liability EU Medical Device Regulations 3
A OHSAS 18001 external auditor finding personal interpretation? Occupational Health & Safety Management Standards 5
J CE Marking for vibrator personal pleasure toy CE Marking (Conformité Européene) / CB Scheme 17
TheMightyWife Can not start Personal Conversations Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 18
L GDPR scope - "Personal data" definition - General Data Protection Regulation EU Medical Device Regulations 5
K Regional Hosting of Personal Health Information Medical Information Technology, Medical Software and Health Informatics 2
A Personal names in docs - Goes against every documenation practice I know! Document Control Systems, Procedures, Forms and Templates 30
L Requirements for employees personal precision measuring tools ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
M AS 4706 (Personal Response Systems) & AS 3811 (Patient Alarm Systems) Equivalents? Other ISO and International Standards and European Regulations 4
J Auditor Training: Examples of Personal Behaviors General Auditing Discussions 10
AnaMariaVR2 Warning Letter to Fercy Personal Care Products - company kicked out FDA Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4
Marc Life after the Personal Computer After Work and Weekend Discussion Topics 14
AnaMariaVR2 Change Anything: The New Science of Personal Success [book] The Reading Room 1
S Clean Room Training for Manufacturing Operators (Personal Hygiene, Gowning, etc.) Other Medical Device and Orthopedic Related Topics 4
J Small Company with an established Secretary/Admin person with "Personal" procedures Quality Manager and Management Related Issues 8
B Customer Property Exclusion as it applies to Personal Data ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
E Should I refuse to answer personal questions during the interview? Career and Occupation Discussions 59
L Calibrating Tool Makers Personal Tools General Measurement Device and Calibration Topics 9
ScottK Companies with no receptionist are colder and less personal Career and Occupation Discussions 12
C ISO 17024 - Personal Certifications Programs Checklist Other ISO and International Standards and European Regulations 27
A Personal Data as it pertains to clause 7.5.4 of AS9100C - Definition AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
M Root Cause Analysis and Personal Blame ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Developing your own personal "Body of Knowledge" document. Professional Certifications and Degrees 3
S Withholding of Information from Employers - Strategic Target or Personal Behavior? Career and Occupation Discussions 14
U Honda U3-X Personal mobility device World News 4
S How to better manage files on a personal computer? After Work and Weekend Discussion Topics 8
A Essential Requirements Checklist for PPE (Personal Protective Equipment) CE Marking (Conformité Européene) / CB Scheme 6
F Personal Notes on Production Floor vs. Documented Work Instructions Document Control Systems, Procedures, Forms and Templates 188
M Your Personal Emergency Preparations Coffee Break and Water Cooler Discussions 15
T On a personal level... Imported Legacy Blogs 1
Claes Gefvenberg Environmental efforts on a personal level Philosophy, Gurus, Innovation and Evolution 30
ScottK Vacation/Sick/Personal days in the USA - how widely do they vary? Career and Occupation Discussions 23
T Document Management Software for Personal Use Coffee Break and Water Cooler Discussions 4
Marc DEC's 'Personal Mainframe' Computer After Work and Weekend Discussion Topics 3
S Does your company allow the use of Personal cell phones during working hours? Coffee Break and Water Cooler Discussions 51
T Personal advice needed on ISO 9001 Quality System and Management ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
O Personal Care/Cosmetics Testing Requirements Manufacturing and Related Processes 1
N Personal Business Software to Track Expenses - I.e. Travel and Business Expenses Career and Occupation Discussions 10
E Sampling Plan for Destructive Testing - Personal Body Armor Plates Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
F Attribute Gage R&R Basis for Applications - Personal Perception Criteria Statistical Analysis Tools, Techniques and SPC 3
A Personal Organizational Tools - What tools do you use for personal organization? Coffee Break and Water Cooler Discussions 26
A Personal control of design drawings/documents Document Control Systems, Procedures, Forms and Templates 8
W Employee Personal Liability once we get our ISO 14001 up and running ISO 14001:2015 Specific Discussions 1
B ISO 14001 Environmental Policy - Personal Liability - Making Managers Sign Policy ISO 14001:2015 Specific Discussions 4
R Do all personal tools need to be calibrated? Why? General Measurement Device and Calibration Topics 4
N % Tolerance - Type 1 study on the gages, then a gage R&R (ANOVA) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
S Formula for Calculating NoGo Major Diameter for UN gages Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
D Preventative Maintenance for Gages, handtools etc Other Medical Device Regulations World-Wide 1
M Procedure or Specification For Extending Gages Calibration Calibration Frequency (Interval) 2

Similar threads

Top Bottom