Procedure for Selection & Use of Measuring Equipment

L

Lundberg

#1
Good morning all, I want to develop a procedure for "Selection & Use of Measuring Equipment". The purpose is to get production (including OM's) and inspection on the same page through a documented procedure.

Can anyone share an example or ideas how this procedure should be written? I've performed searches and I'm unable to find this topic discussed.

My initial idea is to have a matrix and including criteria. In the matrix, 2-3 steps (rows) which include columns of "who", "when" "where the info comes from", "procedure for that step" and "expected results". The criteria = "tool selection for a measureable feature" and “tool selection for range of tolerances”.
 
Elsmar Forum Sponsor

Jim Wynne

Leader
Admin
#2
Re: Selection & Use of Measuring Equipment

Good morning all, I want to develop a procedure for "Selection & Use of Measuring Equipment". The purpose is to get production (including OM's) and inspection on the same page through a documented procedure.

Can anyone share an example or ideas how this procedure should be written? I've performed searches and I'm unable to find this topic discussed.

My initial idea is to have a matrix and including criteria. In the matrix, 2-3 steps (rows) which include columns of "who", "when" "where the info comes from", "procedure for that step" and "expected results". The criteria = "tool selection for a measureable feature" and “tool selection for range of tolerances”.
Just out of curiosity, what prompted you to want to document this sort of thing? It seems that people who are skilled in using measuring devices are probably also capable of selecting the appropriate devices for a given application.

Nonetheless, I do understand a desire for consistency and uniformity, and many companies accomplish this through control plans (either the AIAG type or something home-brewed). Rather than having a document that spells out various types of things to be measured, the appropriate devices, it might be better to develop a plan for each part, as part of the APQP process, where people look the thing over, decide what device to use for measurement of features that might create problems, and document the finding so that whenever that particular part is measured, the same devices are used.
 
#3
Re: Selection & Use of Measuring Equipment

I want to develop a procedure for "Selection & Use of Measuring Equipment". The purpose is to get production (including OM's) and inspection on the same page through a documented procedure.
That could prove tricky... Most of the time you can come up with many different (correct) ways to measure the same thing and get the same result. I have to admit that I have never seen such a document.

Usually I see written procedures or work orders stating that this or that product is to be measured in a certain way, using certain equipment.

You say that you want to get production and inspection on the same page, so I suppose there is a problem? Could you tell us more about that and the products in question?

/Claes
 

ScottK

Not out of the crisis
Leader
Super Moderator
#4
Re: Selection & Use of Measuring Equipment

we do this, as Jim said, in what amounts to a control plan.
We have an inspection database that calls for what characteristics to inspect on first article, in process, final, etc. Each characteristic gives the tool to be used. The tools are selected by the engineering manager and the QA manager based on the accuracy needed at what point in the process.

Example -
the ID on a valve body may call for:
Bore gauge on first article
go/no-go gauge pins in process and final.

For another body we may need to measure with a bore gauge at all control points.

it's all part dependent.
 
L

Lundberg

#5
Re: Selection & Use of Measuring Equipment

Just out of curiosity, what prompted you to want to document this sort of thing? It seems that people who are skilled in using measuring devices are probably also capable of selecting the appropriate devices for a given application.
Stems from an as9100 audit minor finding.

noncon: "inspection documentation didn't include the type of measurement instruments required".

as9100 requirement: "clause 8.2.4.1. measurement requirements for product or service acceptance shall be documented. This documentation may be part of the production documentation, but shall include d) type of measurement instruments required"

Objective evidence: "A review of inspection documentation and interview with inspection personnel revealed that the documentation did not include the type of measurement instruments required".

Maybe I can deal with this through the FAI report. I had 2 auditors and I wasn't with this auditor when the finding was initially discovered. When the auditor explained it to me, the FAI (to my knowledge) was never brought up....just that I needed a "Selection & Use of Measuring Equipment" procedure.

I'm looking into this further and will followup.
 
Last edited by a moderator:

Jim Wynne

Leader
Admin
#6
Re: Selection & Use of Measuring Equipment

Just out of curiosity, what prompted you to want to document this sort of thing? It seems that people who are skilled in using measuring devices are probably also capable of selecting the appropriate devices for a given application.QUOTE]

Stems from an as9100 audit minor finding.

noncon: "inspection documentation didn't include the type of measurement instruments required".

as9100 requirement: "clause 8.2.4.1. measurement requirements for product or service acceptance shall be documented. This documentation may be part of the production documentation, but shall include d) type of measurement instruments required"

Objective evidence: "A review of inspection documentation and interview with inspection personnel revealed that the documentation did not include the type of measurement instruments required".


Maybe I can deal with this through the FAI report. I had 2 auditors and I wasn't with this auditor when the finding was initially discovered. When the auditor explained it to me, the FAI (to my knowledge) was never brought up....just that I needed a "Selection & Use of Measuring Equipment" procedure.

I'm looking into this further and will followup.
I am not an expert on aerospace stuff, but it seems to me that the key is,
This documentation may be part of the production documentation...
Meaning that a specific document isn't required, but a control or inspection plan for each part (the "production documentation") will suffice.
 
K

Keith Childers

#7
Re: Selection & Use of Measuring Equipment

We have a couple of things in place to help production stay in line.
First, we have a gauge training class.
When a new employee is hired, and that employee is going to be expected to make judgements as to the quality of our product based on dimensional checks, we give that employee a competence test.
If their test shows the need for improvement, they go to gauge class.
In gauge class they get hands on training with the types of gauges they will be expected to use on the production floor. They learn the proper names for the gauges, the correct way to use them and how to read them.
There are tests along the way to make sure everyone understands the material, and then the competence test is given again at the end of the class so we can see the employees improvement.
The results of each employess post test is recorded in their training matrix.
When employees come out of class we have some confidence that they will know what they are measuring, how to measure it, and which gauge to use.

Secondly, on all production stations, we have process sheets. The process sheet has the dimension to be measured, the specification and tolerances of the measurement and the type of gauge to be used for the measurement.
Results are recorded on a daily production report.
 
L

Lundberg

#8
Currently, inspection will perform first part buy and fill in the FAI and list the tool used (example micrometer for a dimension that’s +/- .002 or optical comparator for a angle that’s +/- .5 degrees) Production operators measure parts as they come off the machine and perform the roll as “in-process inspector”. It’s the operators’ choice 1) which feature(s) will be measured 2) which tool will be used to inspect each feature. Currently it is acceptable for a operator to use a dial caliper to check a part feature that is +/- .002 (or +/- .001 for that matter).

My purpose is not only to satisfy a audit finding, but it’s to create measurement consistency throughout the organization.

Our quality to the customer is outstanding. 11 out of the last 12 months was 100%. The month that we didn’t achieve 100% was 99.99%. That said, production does move a small number of discrepant parts into final inspection and we are heavy (27% total employment) with final inspector personnel.

We try to keep our processes lean, therefore I don’t believe process sheets are for us…..and yes I believe something like that is for us but I don’t see it happening. My Production Manager wants a “simple tool selection matrix including tolerance criteria” and the PM will hold operators accountable. I’m confident that the PM can make this method work for our company. It’s something the PM and QA Manager wanted prior to the audit finding.
 

BradM

Leader
Admin
#9
Currently, inspection will perform first part buy and fill in the FAI and list the tool used (example micrometer for a dimension that’s +/- .002 or optical comparator for a angle that’s +/- .5 degrees) Production operators measure parts as they come off the machine and perform the roll as “in-process inspector”. It’s the operators’ choice 1) which feature(s) will be measured 2) which tool will be used to inspect each feature. Currently it is acceptable for a operator to use a dial caliper to check a part feature that is +/- .002 (or +/- .001 for that matter).
If I understand your post (please correct me if it's incorrect) the operator can pick up any caliper and measure product. Too, the specific instrument used is not documented anywhere. If that is accurate, then I could see cause for some concern.

You should have a process where, in the unfortunate event of an instrument being found OOT, you should be able to verify what work was measured with that device and any potential impact. NOTE: There are several creative ways to capture this information and maintain your quest for Lean.
 

ScottK

Not out of the crisis
Leader
Super Moderator
#10
hm... why not a matrix? I could see two factors that dictate a tool:
Dimension type
tolerance

so if you have a 'linear exterior' dimension that is, say, 3.000" +/- .050" it might cross at '6" caliper accurate to .0005"'.
Maybe another 'liner exterior' dimension would be .4520" +/- .0050" and would cross at '0-1" micrometer accurate to .0001"'.

It could work. And it would probably be easier than editing or creating a quality or control plan for every part.

but the most important thing to me was pointed out by BradM... you have to have gauge traceability so if a gauge is found out of calibration you can go back to all product measured with that gauge.
 
Thread starter Similar threads Forum Replies Date
K Our selection evaluation procedure Supplier Quality Assurance and other Supplier Issues 1
A Procedure for Supplier Selection and Performance Evaluation - Comprehensive Example Supplier Quality Assurance and other Supplier Issues 5
J Selection Procedure for the Use of Control Charts (Apendix C) Statistical Analysis Tools, Techniques and SPC 2
C Purchasing Procedure - Supplier selection, evaluation and re-evaluation Document Control Systems, Procedures, Forms and Templates 22
D Procedure Pack SOP EU Medical Device Regulations 1
B Inspection procedure for components Oil and Gas Industry Standards and Regulations 8
N Writing Risk Management procedure for small manufacturing and we don't know where to start. Manufacturing and Related Processes 9
M Bourdon gauge calibration procedure failure ISO 17025 related Discussions 3
J Old procedure review and training requirements Document Control Systems, Procedures, Forms and Templates 9
T Cease Production Sample Procedure Manufacturing and Related Processes 1
B Risk Management Procedure updates needed for 14971:2019 ISO 14971 - Medical Device Risk Management 11
S BASIC UDI-DI for a class IIa device marketed in a Procedure kit EU Medical Device Regulations 1
qualprod Statements into a procedure against audits ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
T Internal and external communication procedure for Food Safety Food Safety - ISO 22000, HACCP (21 CFR 120) 2
M Product Acceptance Software (PAS) PROCEDURE (BOEING D6-51991) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
M Design Control Procedure Medical Device and FDA Regulations and Standards News 4
D Out of specification procedure for Medical device manufacturing Manufacturing and Related Processes 7
S Risk Management File - Procedure Packs ISO 14971 - Medical Device Risk Management 3
Moncia Changes to procedure communication ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
H R&D and Design procedures - can one procedure cover both activities Design and Development of Products and Processes 6
D SPC procedure Statistical Analysis Tools, Techniques and SPC 5
J Enough for PSUR to cover product family? (Procedure packs, not the legal manufacturer) EU Medical Device Regulations 1
C Mock recall template/procedure ISO 13485:2016 - Medical Device Quality Management Systems 1
S Help in document control procedure Document Control Systems, Procedures, Forms and Templates 14
B Establishing a Data Analysis Procedure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
B Establishment and Product Registration Procedure - UK & EU UK Medical Device Regulations 0
M Procedure for communication between authorized rep and distributor Other ISO and International Standards and European Regulations 0
M Article 22 - Include statement in procedure pack? EU Medical Device Regulations 1
S Classification of a Sterile Procedure Pack EU Medical Device Regulations 0
A Management of change procedure for ISO 45001 Occupational Health & Safety Management Standards 5
L Product and process Deviation procedure Manufacturing and Related Processes 1
C IVD Metrological traceability without a reference measurement procedure General Measurement Device and Calibration Topics 11
M GP-12 procedure form and requirements Customer and Company Specific Requirements 1
R Procedure pack EU EU Medical Device Regulations 1
B Process / Procedure - Radiographic (X-Ray) Non-Film Document Control Systems, Procedures, Forms and Templates 0
M Procedure for vigilance system according to new MDR EU Medical Device Regulations 0
M Procedure for clinical evaluation according to new MDR EU Medical Device Regulations 11
S Production Work Order Procedure 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
E System&Procedure pack or accessory EU Medical Device Regulations 1
K Do Contract Manufacturers need a complaint procedure? Medical Device and FDA Regulations and Standards News 10
E Design and Development file Procedure ISO 13485:2016 - Medical Device Quality Management Systems 0
B Procedure facility license in karnataka Manufacturing and Related Processes 3
S MDR - System and procedure pack article 22 and all sub processes that apply ISO 13485:2016 - Medical Device Quality Management Systems 0
P Software verification and validation procedure IEC 62304 - Medical Device Software Life Cycle Processes 6
B Procedure packs with non-medical devices EU Medical Device Regulations 1
K Need procedure for D&D inputs? ISO 13485:2016 - Medical Device Quality Management Systems 4
J Example of a defined procedure for carrying out Material Review Board (MRB) Manufacturing and Related Processes 0
A ISO 13485 procedure change and reflect to legacy manufacture items ISO 13485:2016 - Medical Device Quality Management Systems 2
S What should i choose for "testing procedure" characteristics? (N95) General Information Resources 0
S Critical characteristic on manufacturing operations test procedure Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0

Similar threads

Top Bottom