How & how often to perform verification of Test Software of Automatic Test Equipment?

J

Juan Carlos Reyes

#1
#1
Questions:

That somebody has ideas of how to perform
verification and re-checks to test software of Automatic test equipment?

How often we need to perform re-checks.

Reference:QS9000 element 4.11 General
secon Paragraph requirement.
 
GAGEpack - Gage & Calibration Management
Elsmar Forum Sponsor
A

Al Dyer

#2
#2
Start verification once per day and record results.

After results are verified daily move on to a weekly frequency and record the results.

Once the results are verified weekly move on to a monthly verification.

The idea is to verify the ongoing capability and revise frequencies based on the results of previoius studies.

Think of it as an ongoing thought process that can be verified by ongoing studies.

ASD...
 
A

Atul Khandekar

#3
#3
I have a related question. I have developed a custom software package for doing MSA studies. Would this qualify as 'Test Software'? Recently I received a query from a customer which says:

"....as a part of our QS 9000 Requirement where test software are used as suitable forms of inspection/ results, they shall be checked to prove that they are capable of verifying the acceptability of product during the production, or servicing and shall be rechecked at prescribed intervals. We expect you to establish the extent and frequency of such checks, give us the detailed calibration report alongwith the detailed calibration plan in the future and maintain records as evidence of control...."

Any ideas what should be done? What I generally do is enter the published data (eg. from the examples given in MSA manual) into the software and compare the results with published answers. Should this be done periodically??

Thanx.
 
A

Al Dyer

#4
#4
Your methodology is sound although I don't think I would use the MSA manual as the "sole" source of verification, it does have some errors. Verify a few different sets of published data and see if all the numbers crunch the right way.

We have choosen to put verification software in our calibration system to ensure they are not overlooked (i.e. frequency).

ASD...
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
K Gage R&R Frequency - How often to perform the GR&R? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
William55401 How Often Does FDA State Consultant Recommended in a Pharma WL? US Food and Drug Administration (FDA) 1
Ashland78 IATF 16949 9.2.2.1 - How often do we have to audit entire IATF Manual IATF 16949 - Automotive Quality Systems Standard 6
R OSHA - How often an employee needs to be Re-Trained on Safety Methods Occupational Health & Safety Management Standards 4
U Must We Audit Critical Suppliers? How often? Supplier Quality Assurance and other Supplier Issues 7
J How often can AS9102 FAI be invoked? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
A Why Copper Wirebonded Devices often fail at uHAST (130C, 85%RH, 96hrs) Nonconformance and Corrective Action 2
N Is there a standard which states how often instruments should be calibrated? Calibration Frequency (Interval) 12
B How often do you clean your ESD mat? Manufacturing and Related Processes 4
J Guidance on how often company SOPs need to be reviewed per FDA Regulations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
J What are the most often asked questions in an interview? Career and Occupation Discussions 10
K Food safety auditors are often paid by the firms they audit Food Safety - ISO 22000, HACCP (21 CFR 120) 2
AnaMariaVR2 Change them often Funny Stuff - Jokes and Humour 2
F Medical Device Clinical Evaluations - How often are Clinical Evaluations required? EU Medical Device Regulations 2
E Supplier Audits - How often do you need to Audit your Supplier Supplier Quality Assurance and other Supplier Issues 22
Marc A Measure of Trade not often talked about - Cargo Ships Treading Water World News 1
S Internal Auditor Training - How often should an internal auditor be trained? Training - Internal, External, Online and Distance Learning 15
L How often should the contract review be done? TS 16949 Contract Review Process 2
W Gage R&R study frequency - How often should a Gage R&R be performed? Capability, Accuracy and Stability - Processes, Machines, etc. 8
ScottK Industry Snobs - do you run into this very often? (a rant) Career and Occupation Discussions 10
S How often does the FDA inspect organisations outside of the USA? US Food and Drug Administration (FDA) 12
P How often should CMM attribute gages be 3rd party calibrated General Measurement Device and Calibration Topics 1
S How often do you audit your suppliers? Supplier Quality Assurance and other Supplier Issues 19
T Process Capability Data (TS16949 8.2.3.1) - How often should it be reviewed? Capability, Accuracy and Stability - Processes, Machines, etc. 9
P How often do you have to repeat a Gage R&R study? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 27
A "Impossible" Is Often The "Untried" Coffee Break and Water Cooler Discussions 3
C How often will I update the quality records list? We have about 189 quality records Document Control Systems, Procedures, Forms and Templates 6
H How often is Attribute Gage R&R required to be performed? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 10
J How long (how often) do you check your SPC chart? Statistical Analysis Tools, Techniques and SPC 10
A NO2 Output - 4.5.1. How often to measure? Who defines an 'appropriate' period? Miscellaneous Environmental Standards and EMS Related Discussions 2
J How often should we have Assessment / Surveillance Visits? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 44
A 8.2.4.1 Layout inspection - When is a full layout required and how often? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
N How often do objectives and Q-Policy change ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
A When or how often should we update SPC (UCL and LCL) Control Limits? Every month? Statistical Analysis Tools, Techniques and SPC 7
M How often should Lead Auditors take a refresher course? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S How often for micrometer calibration? General Measurement Device and Calibration Topics 10
T Management Review of the QMS (Quality Management System) - How often (Frequency) Management Review Meetings and related Processes 90
M Some people here at the Cove are often brutally honest - Dual/Secret Identities? Coffee Break and Water Cooler Discussions 43
D On-going capability - Can we decide for ourselves how often to measure cpk? Capability, Accuracy and Stability - Processes, Machines, etc. 6
M Must a company be 17025 accredited to perform internal calibrations? ISO 17025 related Discussions 7
S How to perform verification of the Statistical Analysis Software? Qualification and Validation (including 21 CFR Part 11) 7
J Starting a Weibull Analysis: Source on how to perform Weibull Reliability Analysis - Predictions, Testing and Standards 2
E When to perform accelerated aging studies and transport test(OQ or PQ) Qualification and Validation (including 21 CFR Part 11) 4
G Should I perform Gage R&R only at the beginning of a new project? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
F Who can sit in/perform an API audit? Oil and Gas Industry Standards and Regulations 2
V Supplier wants to perform pre-qualifications prior to every run instead of locking in parameters. Supplier Quality Assurance and other Supplier Issues 7
M MDR requires the NB to perform "tests in order to check that the quality management system" EU Medical Device Regulations 3
M Define voltage and frequency to perform tests 61010-1 and 61326-1 for CE certification CE Marking (Conformité Européene) / CB Scheme 4
M Informational How to perform a clinical evaluation of medical devices – Part 2 – Level of clinical evidence and what sufficient clinical evidence means Medical Device and FDA Regulations and Standards News 9
L Gage R&R studies for identical Devices - Need to confirm the requirement to perform them Reliability Analysis - Predictions, Testing and Standards 2

Similar threads

Top Bottom