Validating software in materials testing - Integrated system of individual components

D

DavidPhillips

#1
Hi,
This is my first post into the forum, so please forgive me if I dont understand the system yet.

As a supplier of materials testing equipment we are constantly looking for ways to improve the traceability of test data especially when it is produced by computer.

Testing machines are typically made up of a integrated system of individual components (load cells, extensometers) etc. connected maybe to a electronic machine controller or to interface cards directly in the PC.

All of these items can be successfully calibrated individually by the manufacturer or third party accredited companies to ASTM or EN standards, but after all this is done, the test results from the total system could still be incorrect for many reasons (poor load frame stiffness, insufficient data sampling rate, poor data channel synchronisation, poor algorithms, drive systems inaccuracy, operator error in keying data in, lack of understanding of the limitations of the equipment and how they relate to the testing application etc.).

My questions are:
1) Is this a real-life situation as described above, and how serious is it?
1) How is all of this addressed an organisation's quality system?
2)How can equipment manufacturers help to improve the situation?

thanks in advance
David
 
Elsmar Forum Sponsor
S

Sleepless

#2
My questions are:
1) Is this a real-life situation as described above, and how serious is it?
1) How is all of this addressed an organisation's quality system?
2)How can equipment manufacturers help to improve the situation?

I'll take a shot at, hopefully, giving you some helpful thoughts. I worked in an evironment that created software for statistical processing used in manufacturing pharmaceuticals and refining oil and other things. Our software ran on a server and clients that received data values from a DCS. Since we had no control over the DCS, or other manufacturing equipment, we never attempted to validate any of that. We created a process for our segment of the process. It showed that our software was created according to a strict process. We kept records of changes, reviews, plans, and QA verifications. In our case, we didn't produce the end product, we were just a tool used in the middle of the process so our customers would frequently audit us.

Does that help at all???:(
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#3
I am in test labs all the time.....

It is real.
The best way a manufacturer such as yourself can help is to provide a simple system to use, that collects data from extensometers and other devices to reduce the need for operator input, and should be able to accept input in a variety of ways.....and make sure that your software is appropriately validated under ISO/IEC 17025:2005 and that some evidence is available easily to the labs to show AB assessors.

As for frames and the like, many if not most are unique construction, at least in the U.S. and often are good, but perhaps simple guides of how to construct fixtures that meet ASTM and similar requirements.....make it plain language and at least for the U.S., use spelling here.....

Hope this helps.

Hershal
 
D

DavidPhillips

#4
Re: Validating software in materials testing - Integrated system of individual compon

How many people are carrying out tensile testing on plastics to ISO 527 with video extensometer or other non-contacting extensometry?

When determining the Elastic Modulus, I recently found that there is some confusion in labs who test to ISO and ASTM D638. As you may know there is a big difference between the Standards with regard to the accuracy of extensometry for elastic modulus determination.

ISO 527 example: For a Type 1A or 1B 50mm (2") gage length sample, you need an extensometer with an accuracy of 1um. For smaller gage lengths the accuracy requirement is even higher! so you should check the specification of your extensometers very carefully.
 
Thread starter Similar threads Forum Replies Date
N Validating Software before getting approved as Class 2 device US Food and Drug Administration (FDA) 5
T Risk analysis of QMS software - Validating software we use for QMS ISO 13485:2016 - Medical Device Quality Management Systems 5
M FDA's expectation for validating OTS software updates Other US Medical Device Regulations 8
R Re-validating revised Medical Device and Aerospace Product COTS software ISO 13485:2016 - Medical Device Quality Management Systems 2
M Validating 3rd Party Software which Tracks Archived Samples Qualification and Validation (including 21 CFR Part 11) 2
G Software Validating Adobe Professional according to Part 11? Quality Assurance and Compliance Software Tools and Solutions 10
Ed Panek Validating Excel (XLS) formulas 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
A Validating my own application developed with Agile Qualification and Validation (including 21 CFR Part 11) 5
H Validating Nondestructive leak testing machine Qualification and Validation (including 21 CFR Part 11) 3
S Validating a Bonding Process Qualification and Validation (including 21 CFR Part 11) 3
J Validating a stopped test due to never finding any defects Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
J Validating multiple injection molding machines efficiently ISO 13485:2016 - Medical Device Quality Management Systems 5
J Grouping Products and Testing Sterile and Biocompatibility - Validating Products Other Medical Device Regulations World-Wide 3
G Validating a Process Based on Lot Release Criteria Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
Q Meeting the Requirement of Clause 7.5.2 on Validating Special Processes AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
M Validating a Product through Tool Control and Tool Inspections Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
G Validating a Sandblasting Process - Any pointers? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
G Testing and Validating a New Vertical Milling Machine AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
Q Validating Tape Measures used to Measure Product Conformity to Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Protocol for Validating Pull Tester and Force Gage Qualification and Validation (including 21 CFR Part 11) 9
T Validating Supplier Statement - Rusty shield that supplier denied responsibility Manufacturing and Related Processes 7
Q Validating ESD (Electrostatic Discharge) Flooring ISO 13485:2016 - Medical Device Quality Management Systems 2
M Procedure for Validating Laser Marking & Electropolishing of Orthopedic Implants Other Medical Device and Orthopedic Related Topics 13
Q Validating the AOI process (Automated Optical Inspection) Reliability Analysis - Predictions, Testing and Standards 9
K Validating a gage/fixture in-house under TS 16949 - Need information General Measurement Device and Calibration Topics 2
C Validating Custom adaptations of Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 11
C Validating a Gage R&R spreadsheet - Defining Formulas in spreadsheet cells Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
D Validating Multimeters (how to) General Measurement Device and Calibration Topics 8
Q Software as a medical device vs software not sold as medical device: local regulations for sale? EU Medical Device Regulations 4
Y Software updates considered servicing (7.5.4) ISO 13485:2016 - Medical Device Quality Management Systems 4
S How to perform verification of the Statistical Analysis Software? Qualification and Validation (including 21 CFR Part 11) 2
I Document Control Software Document Control Systems, Procedures, Forms and Templates 2
E Software maintenance Process Software maintenance Process to IEC 6204? IEC 62304 - Medical Device Software Life Cycle Processes 3
L Micro-Vu InSpec Software Program Qualification and Validation (including 21 CFR Part 11) 6
A For software change - New Channel of interoperability CE Marking (Conformité Européene) / CB Scheme 4
T IVDR Medical device software CE Marking (Conformité Européene) / CB Scheme 8
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
C SharePoint Contract Management Software General Information Resources 0
gramps What do you think about automated QA testing For software app industry? Misc. Quality Assurance and Business Systems Related Topics 5
V Software as medical device (SaMD) replicated for multiple clients through APIs IEC 62304 - Medical Device Software Life Cycle Processes 5
U API Spec Q1 - 5.6.1.2 C (3) - Design software Oil and Gas Industry Standards and Regulations 3
B Complaint Records - Accessing records on Easy Track Software Records and Data - Quality, Legal and Other Evidence 3
GreatNate Master Control QMS software Quality Tools, Improvement and Analysis 0
GreatNate Anyone using the Intellect QMS software? Quality Assurance and Compliance Software Tools and Solutions 1
S DHF/DMR/MDF for a software-only, cloud-based, single-instance device Medical Information Technology, Medical Software and Health Informatics 2
H Software Validation for FFS Packaging Machine Qualification and Validation (including 21 CFR Part 11) 1
E Any sample of a full software life cycle IEC 62304 report ( any class )? IEC 62304 - Medical Device Software Life Cycle Processes 1
Q ISO 13485 7.5.6 Validation - Off the shelf Software ISO 13485:2016 - Medical Device Quality Management Systems 3
M ERP / QMS related software standards for Validation IEC 62304 - Medical Device Software Life Cycle Processes 6
J Do Software Subcontractors need to be ISO13485 compliant in the EU? EU Medical Device Regulations 3

Similar threads

Top Bottom