7.6 Validity Of Previous Measuring Results

gpainter

Quite Involved in Discussions
#1
Anyone have an effective method to validate the previous measuring results when the equipment is found not to conform to requirements ?
 
Elsmar Forum Sponsor
M

M Greenaway

#2
Hope this isnt too simplistic, but check the last batch of product with a known good piece of equipment - keep going back until you find the last good batch.
 

Jerry Eldred

Forum Moderator
Super Moderator
#3
We do a material review board. I'll have to go step-by-step to explain:

1. Unit is found out of tolerance by cal lab.
2. Tolerance limits and before/after adjustment readings are recorded by cal lab.
3. Those readings are presented to material review board.
4. Material review board consists of engineers involved in area where the test equipment was used.
5. Those engineers review the out of tolerance readings and compare them with how the unit may have impacted product.

The function of reviewing out of tolerance readings and how they impact product is the job of people who use the equipment. Calibration labs job is to provide them with good information and not make decisions on product. So we have never been any further involved than to provide the out of tolerance data to the user. Only those people who are skilled in the production application of the test equipment are qualified to make product decisions.

If you must make a decision, you would either need the measured readings from the previous calibration on the unit, or you would have to make some assumptions. With measured readings from the previous calibration, you could use linear interpolation and derive an estimate of approximately when the unit went out of tolerance. From there, make decisions on what errors were introduced on product measurements. If you do not have previous calibration data, you would need to pull product samples as in the above reply, and back track until you found satisfactory readings. From that, determine the amount of error in product measurements, and make a decision about product recall.
 
Thread starter Similar threads Forum Replies Date
D Assessing the Validity of Previous Measuring Results? General Measurement Device and Calibration Topics 8
M 7.6 - Validity of the previous measuring results - Is this what validity means? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
T Review the validity of previous monitoring and measuring results ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
E Validity of previous inspections when equipment is found out of calibration Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
J Validity / outcomes measure for custom made medical device ISO 13485:2016 - Medical Device Quality Management Systems 2
F ISO 17025:2017 Clause 7.7 Ensuring the validity of results - Threshold ISO 17025 related Discussions 9
M Informational EU – Application of transitional provisions concerning validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC Medical Device and FDA Regulations and Standards News 2
D MDD Certification Validity after May 2020 EU Medical Device Regulations 12
E ISO 13485 7.6 Control of monitoring and measuring equipment - Assess the Validity ISO 13485:2016 - Medical Device Quality Management Systems 4
J ISO 17025 - Please share a sample procedure for monitoring the validity of results ISO 17025 related Discussions 1
T CE Certification Strategy - Expanding the validity of certificate EU Medical Device Regulations 1
M CE mark validity after Brexit, 29th March '19 EU Medical Device Regulations 6
U ISO 17025:2017 Clause 7.7 Ensuring the Validity of Calibration Results ISO 17025 related Discussions 6
M Is there an Industry Norm for Expiry of Sterilisation Validity? EU Medical Device Regulations 6
somashekar About NB suspension and CE certificate validity EU Medical Device Regulations 12
J EU CE Mark Validity in Non EU countries - Brazil. Taiwan, China, Japan, Mexico EU Medical Device Regulations 1
alonFAI ISO 9001 Quality Manual Validity Period ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
K Validity of Using NCR's to evaluate Performance Nonconformance and Corrective Action 7
G Validity for Thailand Medical Device License and can change Distributor thereafter? Other Medical Device Regulations World-Wide 3
M Validity of Calibration outside the Calibration Range General Measurement Device and Calibration Topics 7
G Validity of Extending Temperature Cycling Various Other Specifications, Standards, and related Requirements 3
C Validity of a 5 year ISO 13485 Certificate ISO 13485:2016 - Medical Device Quality Management Systems 3
A Validity of Internal Auditor Certificate/Training Quality Manager and Management Related Issues 14
A Expiration of Validity Date for EN ISO 14971 ISO 14971 - Medical Device Risk Management 8
A Validity of IEC 60601-1 and IEC 60601-2-27 - An intermittent ECG event recorder IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
R Validity of Calibration Stickers on Measuring Tapes and Rulers General Measurement Device and Calibration Topics 26
rob73 Length of validity of a self certified Declaration of Conformity (DoC) for CE mark EU Medical Device Regulations 4
S Validity of "Ship to Control" - Do you endorse this approach? Statistical Analysis Tools, Techniques and SPC 15
C Validity Duration of USP / FDA Certificate? Other ISO and International Standards and European Regulations 5
V What is the Validity of IEC Test Reports? What about TRF Compliance? Other Medical Device Regulations World-Wide 2
J Length of Validity - Test Results Various Other Specifications, Standards, and related Requirements 2
K ISO 13485 Registration Certificate Life-Time (Validity Period) ISO 13485:2016 - Medical Device Quality Management Systems 21
Q Uncontrolled Hard Copy (Paper) Document Validity Period Document Control Systems, Procedures, Forms and Templates 12
J AS9100 Rev. B Certificate Validity AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
T CE Mark Validity despite expired 13485 Certification EU Medical Device Regulations 13
D IATF portal for TS 16949 Certificate Validity Check IATF 16949 - Automotive Quality Systems Standard 2
S Validity of Craig Hane's Global Local Index for X-bar R Chart Assessment Capability, Accuracy and Stability - Processes, Machines, etc. 3
P Validity of NB-MEDs (MDD / CE marking) EU Medical Device Regulations 2
M Validity of Old Biocompatibility Data (1999) - Catheter Other Medical Device and Orthopedic Related Topics 3
E Validity of ISO 9001:2000 Certificates - How to handle supplier ISO 9001 certificates ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
V Criteria used to assess the Validity of a Complaint - Insurance Company Customer Complaints 4
L How to check for validity of registration scope during ISO9001:2008 external audit Quality Manager and Management Related Issues 3
A Validity of ISO 9001 Certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
D Time frame for validity of ISO 9001:2000 Certifications IATF 16949 - Automotive Quality Systems Standard 3
C ISO 9001:2000 Certificate - How to have a 3 year validity instead of 1? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
C Ever come across an ISO 9001 certificate with more than 3 years validity period? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 35
S Validity of 7 Year Old Calibration Certificate General Measurement Device and Calibration Topics 19
D Validity of ISO 17025 calibration waivers due to proprietary procedures ISO 17025 related Discussions 4
E COA's (Certificate of Analysis) from suppliers - Beginning to question validity Supplier Quality Assurance and other Supplier Issues 4
P CE certificate validity - Signing employee has left the company EU Medical Device Regulations 7

Similar threads

Top Bottom