Unique ID Required for Thread Gage Replacements?

SpinDr99

Involved In Discussions
I'm in my first machine shop where they use a lot of thread plug and thread ring gages. As they will now and then, a gage goes out of calibration. It may be either the "Go" or "No-Go" member of a thread plug gage, or one of the thread ring gages. To keep them as a set before I came to the company, both were given the same I.D. number. My predicament is when one fails calibration. I cringe at the thought of re-issuing the same I.D. number to the replacement, and this is especially a predicament when we're talking about a thread plug gage which share a handle.

I've thought about simple discarding the "failed" thread ring gage member and keeping the I.D. the same, but this goes against all everything I believe is the correct thing to do. Does anyone have some input as to what they do in their shop and how to get around any questions from a CB auditor? I THINK I can cover myself by making a statement in our Calibration procedure that the "failed" thread ring gage member will be removed from the property (thrown out).
 
Last edited by a moderator:
B

BoardGuy

[FONT=&quot]For ring gages each member of the set should have its own ID number for control purposes. Plug gages on the other hand are usually handled as being a single unit with just one ID number. Most plug gages I worked with had sterilized individual members (go/no go) in the handle. If this is the case with your plug gages just record that on Plug Gage ID # XYZ, No Go Member S/S 123 was replaced by Member S/S 456.

[FONT=&quot]If each plug g[FONT=&quot]age member is in its own handle, then just retire the complete gage (handle & [FONT=&quot]plug) and issue [FONT=&quot]the replacement [/FONT]with a new number.[/FONT][/FONT][/FONT]

[/FONT]
 

SpinDr99

Involved In Discussions
Thanks for your input. Unfortunately, I inherited a mess as my company just got their ISO certification last year and the plugs share a handle, and the rings (Go and No-Go) were set up with the same number. On top of that, the previous administrator of the gages was re-using ID numbers, and I can't extend calibration intervals as management wants because histories weren't retained.

But getting back to replacing failed rings or plug members (which share the same handle), I'm all ears. Thanks!!!
 
Thread starter Similar threads Forum Replies Date
C Control of Documents - Is a unique format required? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
J Where traceability is required, the unique identification of the product is recorded ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Supplier Control for Unique Product ISO 13485:2016 - Medical Device Quality Management Systems 6
L Unique Supplier Control Issue AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
M Unique Quality Management System for 2 sites ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
K Is UDI (Unique Device Identifier) symbol mandatory under EU MDR? EU Medical Device Regulations 11
John Broomfield Interesting Discussion Regionally unique food and drink Coffee Break and Water Cooler Discussions 4
M Informational EU – Unique Device Identification (UDI) System – FAQs Medical Device and FDA Regulations and Standards News 0
K Unique Device Identifier for updates to legacy standalone software Other US Medical Device Regulations 1
M Informational Commission Implementing Decision (EU) 2019/939 of 6 June 2019 designating issuing entities designated to operate a system for the assignment of Unique Medical Device and FDA Regulations and Standards News 0
M Informational USFDA final guidance – Unique Device Identification: Convenience Kits Medical Device and FDA Regulations and Standards News 0
S Looking for procedure on UDI (Unique Device Identification) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S UDI (Unique Device Identification) Requirements for Remanufactured devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T Unique Device Identifier Advice Other US Medical Device Regulations 1
Edward Reesor UDI (Unique Device Identification): HIBCC or GS1? ISO 13485:2016 - Medical Device Quality Management Systems 39
H UDI (Unique Device Identification) Requirements for IVD Software EU Medical Device Regulations 2
Pmarszal UDI (Unique Device Identification) Transition Period - Packaging Labeling Other US Medical Device Regulations 5
B Class II Medical Device UDI (Unique Device Identification) Question(s) Other US Medical Device Regulations 8
D 820.120 UDI (Unique Device Identification) Labeling Verification Requirements Other US Medical Device Regulations 11
D attribute gage RR in a unique way Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
S Understanding UDI (Unique Device Identification) Other US Medical Device Regulations 10
M UDI (Unique Device Identification) for Convenience Kits with several options Other US Medical Device Regulations 3
O Unique situation regarding a Veterinary Medical Device and ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 4
M UDI (Unique Device Identifier) ISO/IEC 15459 (Unique Identifiers) Requirements Other US Medical Device Regulations 4
bio_subbu USFDA issues final guidance on Global Unique Device Identification Database (GUDID) Other US Medical Device Regulations 1
J UDI (Unique Device Identification) and Reprocessing Medical Devices Other Medical Device Regulations World-Wide 10
K UDI (Unique Device Identification) requirements of US FDA US Food and Drug Administration (FDA) 4
M UDI (Unique Device Identification) Verification Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
Ajit Basrur ICCBBA Is Now an FDA-Accredited Issuing Agency for Unique Device Identifiers (UDI) Other US Medical Device Regulations 1
C UDI (Unique Device Identifier) Definition of Labeler Other US Medical Device Regulations 1
M Official EU Unique Device Identifier (UDI) Requirements EU Medical Device Regulations 3
E Unique Device Identifier for Small Dental Screws ISO 13485:2016 - Medical Device Quality Management Systems 3
Sam Lazzara 12 Steps to FDA UDI (Unique Device Identification) Compliance (2013 - 2015) Other US Medical Device Regulations 45
C Looking for 3rd party audit firm for unique contract, have RFP General Auditing Discussions 1
X FDA UDI (Unique Identification) amendment on 19 Nov 2012 - Date of 'final rule'? US Food and Drug Administration (FDA) 4
W Class II Medical Device Unique Device Identifier (UDI) Requirements US Food and Drug Administration (FDA) 8
R Unique Device Identifier for Software Medical Device Other US Medical Device Regulations 3
S US FDA Unique Device Identification (UDI) Proposed Rule 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 18
suildur Sterilization Validation of a Unique Medical Device Other Medical Device Related Standards 5
K Why Quality Assurance is Unique Misc. Quality Assurance and Business Systems Related Topics 8
M Calibration Unique Device Naming Calibration and Metrology Software and Hardware 3
Ron Rompen Very Unique Prototype Requirement - Cutting Holes in Tubing Manufacturing and Related Processes 2
N Unique Document Identification Numbering System Document Control Systems, Procedures, Forms and Templates 69
Q FDA's Unique Device Identification, New Regulations - Pending March of 2010 ISO 13485:2016 - Medical Device Quality Management Systems 3
M FDA Unique Device Identifiers on the labeling of devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
T Acronyms/Unique terms in ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
A Unique Opportunity for QM - 'Chief Quality Officer' ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
S Correct Document Control - Does each Document need its own Unique Numbering? Document Control Systems, Procedures, Forms and Templates 13
T Unique automobile on Ebay Coffee Break and Water Cooler Discussions 3
S Looking for Unique forum for Design and Development Design and Development of Products and Processes 6

Similar threads

Top Bottom