Reference Only Measurement Devices

N

noboxwine

#1
Our biz, water valves and hydrants is simply not design intensive. Make the components look somewhat like the drawing, put ‘em all together and then ultimately, it’s only about fit, form and function at final assembly. With the exception of metallurgical integrity or an operator sleeping during a tool crash, the parts will always work; even if they occasionally fall outside of the gauge. Simply adjust and go on. “Gauges” are attribute (go – no go), and basically only used to verify a set up. Some “gauges” are simply mating components from inventory. After that, we may check one once in while but never on a specific frequency nor in a batch containment situation. My experiments have proven no performance improvement by doing this. Now, to make a long story a bit longer, I cannot cost justify subjecting these gauges through a full-blown calibration system. What about the infamous “Reference Only” sticker? How can I manage this part of the business both cost effectively and stay within the minimum requirements of 7.6? My heart tells me that final assembly is the only thing I care about and whatever happens before that is only for reference purposes. If I haven’t completely confused everyone, your opinions would be greatly appreciated. Don’t sugar coat it! Please tell me what I need to know and thank you very much. :confused: :bigwave:
 
Elsmar Forum Sponsor

Mike S.

Happy to be Alive
Trusted Information Resource
#2
Seems to me the first line of 7.6 says you determine what to measure and how to measure it (with the goal of ensuring the stuff meets spec’s./customer requirements). If you can’t find a nationally or internationally traceable standard that suits you to measure your parts, I’d say make your own guage/measurement device and write down how you will calibrate or verify it as allowed in section (a). For example, if you can get the job done by checking to see if a certain part from inventory “mates” with the newly made part, I’d pick a “guage” part from inventory that looks “typical” to me, and call it my “standard”. Maybe “calibration” or “verification” is comparing it visually to a second “backup standard” that is not used but kept in a fur-lined case. Does this make any sense? Am I nuts?
 
#3
OH NO!

My computer started shuddering. I thought I read "Reference Only"!

A couple of questions. First, if the gauge has no real value (other than setup) why use it? If it is necessary, why not verify it? Remember, it is YOUR system and YOU make the rules. It is better you decide how you are going to do things and stick by them, than to just say "Reference Only".
 

E Wall

Just Me!
Super Moderator
#4
How about this for brief and simple:

"Assembly GO/NO-GO guages and final product guages are the only identified monitoring and measuring devices used by Company X. These guages will be stored wherever is appropriate (drawer/wall mounted/etc..) and inspected visually every day by the associate using them for chips/cracks/rust/etc...and at least once every 2 years against a master guage (? use whatever is appropriate). Replacement guages are kept in the parts room if needed (?)

- At the Assembly point: At the start of each machine shift, a first article inspection will be performed against the guage (#****).

- At Final product testing: When packaging product, #X parts will be verified to the guage (#****).

No record will be kept of process inspections unless there is a nonconformance identified. Both the supervisor and QA inspector will be notified of any nonconforming product imediately."


The sticky whicket (so to speak) is the requirement to "assess and record the validaty of previous results if the equipment is found not to conform to requirements."

"If the guage is found to be out of tolerance a sampling of the previous machining shift product will be performed (sampling plan to be specified by the QA Manager) and if found nonconforming the material will be handled according to the nonconforming product guidelines.

This information shall be recorded on form XXX and kept on permanent file with that days production reporting data."


The key is: Have you evaluated what your needs are and have you put whatever the necessary measure are in place (along with how are they review/monitored for continued serviceability).
 

E Wall

Just Me!
Super Moderator
#5
How about this for brief and simple:

"Assembly GO/NO-GO guages and final product guages are the only identified monitoring and measuring devices used by Company X. These guages will be stored wherever is appropriate (drawer/wall mounted/etc..) and inspected visually every day by the associate using them for chips/cracks/rust/etc...and at least once every 2 years against a master guage (? use whatever is appropriate). Replacement guages are kept in the parts room if needed (?)

- At the Assembly point: At the start of each machine shift, a first article inspection will be performed against the guage (#****).

- At Final product testing: When packaging product, #X parts will be verified to the guage (#****).
"

****Create a reference list of guages and where used if need be and refer to the document rather than the guage #****

"No record will be kept of process inspections unless there is a nonconformance identified. Both the supervisor and QA inspector will be notified of any nonconforming product imediately."

The sticky whicket (so to speak) is the requirement to "assess and record the validaty of previous results if the equipment is found not to conform to requirements."

"If the guage is found to be out of tolerance a sampling of the previous machining shift product will be performed (sampling plan to be specified by the QA Manager) and if found nonconforming the material will be handled according to the nonconforming product guidelines.

Nonconforming product information shall be recorded on form XXX and kept on permanent file with that days production reporting data."


The key is: Have you evaluated what your needs are and have you put whatever the necessary measure are in place (along with how are they review/monitored for continued serviceability).

If you can get buy with simpler great - if you need more detail...make it so!
 
N

noboxwine

#7
Thanks very much to all. I think by marrying these replies together, I can maintain low costs, make good parts and comply. Thanks again !
 
K

Ken K

#8
Ouch!

Our biz, water valves and hydrants is simply not design intensive. Make the components look somewhat like the drawing, put ‘em all together and then ultimately, it’s only about fit, form and function at final assembly.



I may not sleep well tonight...:(
 
M

M Greenaway

#9
Ken

I share your concern.

This looks extremely alarming in both the methods undertaken, and the attitude of the company.

I would assume that any valve operates under a certain pressure, and therefore has certain safety considerations that must be addressed. I have worked for a valve manufacturer, although they were very high pressure valves used for all sorts of unhealthy media, I would have thought similar safety considerations must be thought of.

Maybe noboxwine has just explained it so that it sounds worse than it actually is - I would be interested to hear more detail.
 
N

noboxwine

#10
Re: Ouch!

Ken K said:






I may not sleep well tonight...:(
Don't worry. Everything is 100% tested far above regulatory standards.

That's why I want to put the energy into other parts of the system instead of calibrating a thread gauge for a stem which has never failed in the field.

Sleep tight !
 
Thread starter Similar threads Forum Replies Date
R Definition Reference Measurement Procedure - Definition as specified in ISO 13485 7.5.1.1 b) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 4
P RPS (Reference Positioning System) Measurement for Auto Parts General Measurement Device and Calibration Topics 8
R Definition needed in ISO13485 - 7.5.1.1 b) - Reference Measurement Procedures ISO 13485:2016 - Medical Device Quality Management Systems 3
S What to reference when using (not calibrating) handheld measurement equipment General Measurement Device and Calibration Topics 5
N IEC 60601-1-1 - Stress test, reference voltage IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
CycleMike GD&T - Hole pattern - Print (attached) has a single Datum Reference Frame Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
J Sample size for creating a data base as a reference to a tested variable Other Medical Device and Orthopedic Related Topics 6
R ASQ reference material clarification - Spiral bound materials allowed in ASQ Exam? Professional Certifications and Degrees 1
D Good Acceptance Activity/Inspection flowchart for reference - Wanted Please Process Maps, Process Mapping and Turtle Diagrams 2
G Customer complaint over a Reference Dimension Manufacturing and Related Processes 9
G Measure 3 times, for calibration report? Customer Owned Reference Standard General Measurement Device and Calibration Topics 4
I Data Backup Plan - Document Reference ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Q How to efficiently and compliantly reference external standards/regulations Other Medical Device Related Standards 2
S Lot assignment for secondary reference standard - Pharmaceuticals Manufacturing and Related Processes 0
V Inspection with 3D Scanning - Reference Data Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
E Ethylene Oxide Sterilization Validation-Reference Load Other Medical Device Related Standards 2
C Must your reference standard provider be ISO17034 certified to meet your testing lab's ISO 17025 certification requirements? Other ISO and International Standards and European Regulations 2
C Do Calibration Reference Standards require an MSA study? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
J Purpose of Reference Section in SOPs Document Control Systems, Procedures, Forms and Templates 6
M Quality Policy - Standards and reference numbers ISO 13485:2016 - Medical Device Quality Management Systems 14
M Reference to IATF 16949 clause 8.4.3 in clause 8.3.4.4, Is it right? IATF 16949 - Automotive Quality Systems Standard 1
S Reference calibration tools (traceable to NIST) that are not used in production ISO 13485:2016 - Medical Device Quality Management Systems 4
S Contract Manufacturer Question - Whether or not the reference to the ex-CMO ISO 13485:2016 - Medical Device Quality Management Systems 6
B Need to convert Reference Only M&TE to a calibration schedule General Measurement Device and Calibration Topics 3
M Looking for Cross reference of AS9100:2016 to ISO13485 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
E Print only has Reference Dimensions Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
V QMS / QSR - Reference to Framework - Templates - Procedures for Medical Devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
R How to Cross-Reference Controlled Documents Document Control Systems, Procedures, Forms and Templates 3
E IEC 60601-2-25 Reference to 60601-1 2nd Edition IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
D Visual Inspection with No Visual Reference General Measurement Device and Calibration Topics 2
M AS9100 Rev. D - Can anyone recommend a good reference book? Book, Video, Blog and Web Site Reviews and Recommendations 7
B When to use "For Reference Use Only" on documentation Document Control Systems, Procedures, Forms and Templates 4
G BCARs/EASA to ISO9001/AS9100 cross reference matrix/table wanted EASA and JAA Aviation Standards and Requirements 1
J In the ISO 9001:2008 company, can give reference to sister company also. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
E Use of Certified Reference Materials for Quality Assurance General Measurement Device and Calibration Topics 6
A Reference Source for Polarity Symbol Other ISO and International Standards and European Regulations 1
quality1 Multiple Quality Standards - AS9100 and ISO13485/9001 Cross Reference Matrix Quality Manager and Management Related Issues 3
elkel Reference Only on Gage or Visual Aid Calibration Frequency (Interval) 4
F Quality Objective Reference Chart Customer Complaints 4
V Good Documentation Practices - FDA Reference US Food and Drug Administration (FDA) 9
M Good reference sites or material to help me brush up quickly on Gage R&R Reliability Analysis - Predictions, Testing and Standards 7
J How does Layout Inspection determine Reference Value? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
W Do "Reference Only" documents have to be physically marked/labeled? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
S ISO 9001 Clauses which reference the 8 Principles of Quality Management ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S Where could I get reference to an OQA Sampling Plan of 1 per 1000 ? Quality Manager and Management Related Issues 4
H Can I get some information... CRM (Certified Reference Materials) General Measurement Device and Calibration Topics 3
B Gage R&R Criteria on page 78 MSA Reference Manual Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 10
N Client Request for Reference Equipment Calibration Certificate General Measurement Device and Calibration Topics 3
S What Reference Material is allowed in the ASQ CQA Exam ? Professional Certifications and Degrees 1
B MSA 4th edition reference manual - Page 120-121 Clarification Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6

Similar threads

Top Bottom