Review the validity of previous monitoring and measuring results

T

T.J. - 2005

#1
First time posting, Been coming here for years and have gonna alot of help just reading forums. I am kinda shy and the quite type.
As I read "Review the validity of previous monitoring and measuring results when equipment is found out of calibration, and take necessary actions."
I believe I am looking for evidence of assessing and documenting the validity of previous test results when inspection equipment is found to be out of calibration.
Now I know you need to take action to check product measured by device.
But I read this to say " look at previous test results, if device was out of calibration last time. 1 you need to look at how the device is used 2 the frequency of calibration and 3 Personnel using device and determine action needed.
Am I going in the wrong direction here? :frust:
 
Elsmar Forum Sponsor

Mike S.

Happy to be Alive
Trusted Information Resource
#2
T.J.,

I look at it like this: Say I calibrate my micrometer and find it was measuring + .0005" over actual values, while my procedure says they should read within +/- .0001" to be considered "in cal". Now, I need to determine what (if any) product(s) I measured with these micrometers between the time I knew they were in cal and when I found them out of cal. Say I calibrated them May 1 but did not use them until July 1, and found them out of cal on August 1. So anything I measured between July 1 and August 1 could have been adversely affected by these mics.

For example: Were they used for final inspection during that time? If so, could this have caused me to ship bad product to the customer? If yes, what customer(s) do I need to notify of the potential problem? If I’m lucky, I used them to measure a product with a +/- .005” tolerance and none of them measured more than +/- .002” from the target, so the .0005” error did not cause any rejected product to ship to the customer.

Make any sense? Did this answer your question?
 
T

T.J. - 2005

#3
7.6 The organization shall take appropriate action on the equipmentand any product affected. I'm asking about equipment.
The last measurement resultsshowed the gauge was out of calibration (and of course before putting back on the floor we repaired it, and calibration good) but that was 120 days ago. Does this mean action needs to be taken on the equipment.
 
R

Rob Nix

#4
I don't follow. The "equipment" is your measurement device. You repaired it, therefore you took appropriate action. Is the device still calibrated properly?

I think Mike's reply was right on the money. I don't think it is any more complicated than that. Am I missing something?
 
T

T.J. - 2005

#5
OK thanks,
I guess I was looking to write up corrective action for frequency of calibration if every 120 days the device is out of calibration or training on use etc. Put we are just looking at product here and if we repaired the device. Trying to read more into it i guess.
 
#6
T.J. said:
I guess I was looking to write up corrective action for frequency of calibration if every 120 days the device is out of calibration
You may still need to change your calibration frequency. If you calibrate every 120 days, and each time the device is out of specs, then you really need to have calibration more frequently. One of the "shalls" in 7.6 begins with: "Where necessary to ensure valid results..." If your calibration requency is so far apart, that the device is out of calibration each time, then one could argue that you are in violation of the above.
 
#7
Good response Mike :agree:
In addition, if you calibrate your mics every 3 months and find 1 of 10 out of calibration, causing you to have to notify customers and revisit measurements, you need to re-evaluate and reduce your calibration cycle. Based on data, of course, you might need to calibrate them monthly to make sure that you don't get out of cal conditions. You may also find that they are never out of cal at 3 months and end up (more efficiently and thus more profitably) calibrating every 6 months.
 
T

T.J. - 2005

#8
Toolings argument was it is being calibrated at specified intervals. My argument was I was looking at previous measuring results for equipment and for product.
I am looking at previous measuring results for equipment to see if action is taken for previous out of calibration equipment.
"Where necessary to ensure valid results" are you saying this states "Where necessary to ensure good results"
 
#9
TJ,
More like "necessary" results. If your device is out of cal by 0.005" every time and you are using it to measure +/- 0.050" then it is a "don't care". Based on data, you need to determine if the out of cal condition matters to the measurement, if it does, then:
1) Make sure that you don't have bad product in customer hands and notify or otherwise correct that situation, then:
2) Check if the device is capable of making the measurement (how it is used)
3) Check if you are calibrating it often enough (frequency)
4) Check if your operators know how to use the device without compromising its capability
5) Correct 2, 3, and 4 if necessary.
 
Thread starter Similar threads Forum Replies Date
T Management review - how do you do your meeting? to get best response and involvement? and outputs Quality Manager and Management Related Issues 12
T Document Review Process Map AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
T Ensuring Document Review AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
D 8.3.2.1 Review of the Requirements for Products and Services. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
D 8.2.3.1 Review of the Requirements for Products and Services AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
W Part 145 Maintenance Data Review EASA and JAA Aviation Standards and Requirements 1
Y EU MDR Technical Documentation - Defined Review EU Medical Device Regulations 1
V Review of the Requirements of products and services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
CPhelan Optimizing Training Review Training - Internal, External, Online and Distance Learning 4
T FDA PMA review process - advisory panel timing? Other Medical Device and Orthopedic Related Topics 0
J Periodic review of Documents during management review Document Control Systems, Procedures, Forms and Templates 26
I Section 8.2.3.1 Order Review ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
J Old procedure review and training requirements Document Control Systems, Procedures, Forms and Templates 9
D Increasing efficiency - Capt. Proj. Document Review Matrix Document Control Systems, Procedures, Forms and Templates 4
M Is complete testing required as per ISO 10993 for materials used in orthopedic implants or is literature review route possible Other Medical Device Related Standards 3
S Scope of management review ISO 13485:2016 - Medical Device Quality Management Systems 5
M Are we getting scammed by our Notified Body? They are asking to review all changes to determine if they are Significant CE Marking (Conformité Européene) / CB Scheme 4
M Review of work - independent review? or can it be the same person ? ISO 17025 related Discussions 1
H Management review IATF 16949 - Automotive Quality Systems Standard 9
C Bulk Record Retention Review Records and Data - Quality, Legal and Other Evidence 4
FRA 2 FDA Product NCRs- Quality Review Nonconformance and Corrective Action 6
J How to evaluate the effectiveness of management review? IATF 16949 - Automotive Quality Systems Standard 2
S Customer audit report review and approval ISO 13485:2016 - Medical Device Quality Management Systems 3
D 62304 code review, unit test, integration test example IEC 62304 - Medical Device Software Life Cycle Processes 2
P Product Quality Review API-GMP Manufacturing and Related Processes 0
R Quality policy review document IATF 16949 - Automotive Quality Systems Standard 3
Q Management Review ISO 9001-2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 36
M ISO27001 18.2.1 - Internal Independent review IEC 27001 - Information Security Management Systems (ISMS) 1
M CER Review EU Medical Device Regulations 2
JoCam Non CE marked device for customer review Other Medical Device Regulations World-Wide 0
D Control chart selection of multiple batches review Statistical Analysis Tools, Techniques and SPC 6
F Need help in IMS management review Management Review Meetings and related Processes 3
M Resume Review Request - Quality Assurance Career and Occupation Discussions 11
T Using Review articles from Pubmed for CER CE Marking (Conformité Européene) / CB Scheme 8
M Management Review Inputs ISO9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
D Timelines for COVID-19 desktop review UK Medical Device Regulations 0
D Key Performance Indicators / KPI Review IATF 16949 - Automotive Quality Systems Standard 11
B ETO Annual review ISO 13485:2016 - Medical Device Quality Management Systems 1
J How many hours for a NB to review Technical Documentation? EU Medical Device Regulations 6
M Origin of Material Review Board AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
J NCR- Failure of contract review process - NADCAP audit AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
H Has anyone undergone MDR FQA review yet? EU Medical Device Regulations 10
A MDR - Legacy Device Review Timeframe and Requirements EU Medical Device Regulations 3
A Complaint review as part of the complaint handling process? ISO 13485:2016 - Medical Device Quality Management Systems 3
A Document Review and Document Approval --- 2 Signatures needed acc. §820.40? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
Y Procedures on Contract Review Document Control Systems, Procedures, Forms and Templates 3
J Example of a defined procedure for carrying out Material Review Board (MRB) Manufacturing and Related Processes 0
A API Monogram audit review process Oil and Gas Industry Standards and Regulations 5
S Transitional Adolescent A and B - "CDRH PREMARKET REVIEW SUBMISSION COVER SHEET FORM FDA 3514" Medical Device and FDA Regulations and Standards News 1
S Risk Management Review ISO 14971 - Medical Device Risk Management 4

Similar threads

Top Bottom