Testing criteria - where to place

Maximics

Starting to get Involved
#1
Hi all,

I have a new role as requirements checker for an undisclosed automotive company and need a bit of advice.
My team have been arguing with our stakeholders that the acceptance criteria for a design verification test (regardless of the test type and requirement type), e.g. a CAE test or a virtual design review, a CAD test, shall be detailed/explained/written in the parent requirement of the test, not into the text of the test case. The problem is we don't have strong arguments for our position, is just - "this is how we have done", but I would like to change that.

Any view and arguments on this, please?
Thanks
 
Elsmar Forum Sponsor

Randy

Super Moderator
#2
1- What's wrong with the present method?

2 - What harm could result from the change?

3 - Who's paying the tab, you or your stakeholder's?
 

Maximics

Starting to get Involved
#3
Hi Randy,
Reading your questions I have find the right answers - thank you for this, I guess I needed someone else to phrase the questions out loud for me.

Thanks
 
Thread starter Similar threads Forum Replies Date
lanley liao Purchase Acceptance Criteria - Tensile testing Oil and Gas Industry Standards and Regulations 2
M Characterization Testing - NO acceptance criteria, no minimum performance requirement Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
S Verify Software System Testing: Verify that results meet the Pass/Fail Criteria IEC 62304 - Medical Device Software Life Cycle Processes 1
H Package Integrity Testing Acceptance Criteria ISO 13485:2016 - Medical Device Quality Management Systems 3
R AC7101/11 Nadcap Audit Criteria for Materials Test Laboratories ? Fastener Testing Various Other Specifications, Standards, and related Requirements 1
D 76/211/EEC 2.3.3.1 Criteria for Non-Destructive Testing Statistical Analysis Tools, Techniques and SPC 2
S Pharmaceutical Shelf Life Testing Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
D How to testing of Pressure relief valve as per API 6D ? Oil and Gas Industry Standards and Regulations 1
J Impact Testing--Is conversion between Izod and Sharpy Possible? General Measurement Device and Calibration Topics 3
O Should a Covid vaccine and testing policy be included as part of ISO9001 or AS9100 risk management? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
V How to select the tests for proficiency testing Measurement Uncertainty (MU) 0
B Customer Preference Testing Customer and Company Specific Requirements 2
N Pre-Clinical Performance Testing Design and Development of Products and Processes 3
I Software (SaMD) mobile application verification testing: objective evidence Medical Information Technology, Medical Software and Health Informatics 2
I How to find required testing for a specific device? Other US Medical Device Regulations 3
J CQI-9v4 Alternative TUS Testing Methods Various Other Specifications, Standards, and related Requirements 0
M ASTM F1717 Static and Dynamic Testing 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
T Mold Limits for Microbiology Testing Other Medical Device Related Standards 3
S Orthopedic implant sterility testing Medical Device and FDA Regulations and Standards News 1
H Independence between the development and testing IEC 62304 - Medical Device Software Life Cycle Processes 6
M Issues with leakage current testing for a CLASS II device since no PE and FE is present IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
E 60601-1 - Tilt testing - Tensile safety factor IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
V Setup for testing against ISO14708 clause 16 (protection of the patient from herms caused by heat) Other Medical Device Related Standards 0
gramps What do you think about automated QA testing For software app industry? Misc. Quality Assurance and Business Systems Related Topics 5
B In house NIOSH pre Testing accepted by NIOSH? US Food and Drug Administration (FDA) 1
M Bacteriostasis/Fungistasis Testing Other Medical Device and Orthopedic Related Topics 6
P Sample Size for Distribution Simulation Testing Inspection, Prints (Drawings), Testing, Sampling and Related Topics 11
N EN 813, EN 12277, EN 1497 - Testing some harness prototypes to an EN standard Various Other Specifications, Standards, and related Requirements 0
S What should i choose for "testing procedure" characteristics? (N95) General Information Resources 0
D Essential performance and EMC immunity testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
J Biocompatbility testing on Class 1 device requirements Other US Medical Device Regulations 12
Q Summative Usability Evaluation Testing: prior or during Clinical Investigation? Human Factors and Ergonomics in Engineering 11
B NIOSH Approval for Surgical N95 Respirators - Required testing US Food and Drug Administration (FDA) 2
M ECG lead leakage currents - How to specify ECG leads during electrical safety testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
C Stress / Challenge Conditions for Design Verification Testing to Reduce Sample Size 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
D CFR Title 14: Aeronautics and Space PART 120—DRUG AND ALCOHOL TESTING PROGRAM Federal Aviation Administration (FAA) Standards and Requirements 3
M Device mounted at IV pole - what about mechanical stability testing? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A Outsourcing IEC 60601-1 Ed 3.2 Testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
J Cochlear Implant Testing 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A Class I (exempt) testing requirements Other Medical Device Related Standards 1
JoCam Electrical Testing for Japan, PSE or CB Scheme Other Medical Device Regulations World-Wide 0
M Who are the go to companies for non-destructive hardness testing? General Measurement Device and Calibration Topics 3
M Determining if an Insulin Pen Testing Machine is a Medical Device? EU Medical Device Regulations 4
P Testing cloud-based backups IT (Information Technology) Service Management 7
I IATF Lab Scope Testing Qualification and Competency Documentation IATF 16949 - Automotive Quality Systems Standard 3
N Chemical Testing on Medical Devices - Solutions in a container closure system (bag) EU Medical Device Regulations 1
M Comparing data from destructive testing Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
T Flammability testing Reliability Analysis - Predictions, Testing and Standards 0
E Manufacturers should develop a testing device for covid19 Service Industry Specific Topics 0
K When is Bioburden Testing Required? Other Medical Device Related Standards 8

Similar threads

Top Bottom