Verification protocol example

#1
Hello,
I want to get into V&V testing in the medical device field, after working for a small company as a testing engineer.
I get a lot of questions in interviews if i know how to write a Verification/Validation test protocols, and i'm not sure that the protocols i used to write in my previous company are V&V protocols.
I searched for examples online but haven't found a good example for it.
Does anyone have an example or template for it?
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
Not sure if there could be a single template that would cover all bases. I think the focus should be on what information to capture.

Some of the things that are important in device V&V testing include (not necessarily a comprehensive list):
  • Well defined pass/fail criteria
  • Use of appropriate statistical techniques and justification for sample size (when appropriate)
  • Proper setup defined, including but not limited to:
    • if the device is intended to be used with other devices, testing should be done with the other devices in such use
    • environment (lighting, background noise, etc.)
  • Ensuring you capture objective evidence that the results meet the acceptance criteria (just documenting pass/fail or "meets expectations" is generally too weak - ideally, capture sufficient evidence that an independent observer with sufficient background info can draw the same conclusion that the tester made)
  • Identifying measurement equipment used (I recommend ID, last cal date, and cal due date)
  • Identifying the tester and the date(s) the test was conducted
  • Traceability (not necessarily in the protocol) between applicable requirements and the tests
Do recognize the difference between verification protocols and validation protocols. Validation generally requires the intended user community be involved and is frequently based on qualitative scoring (e.g., rate the ease of use on a scale of 1 to 5 with 1 being extremely difficult...). Validation also requires that the items tested are production or production equivalent units.
 

indubioush

Quite Involved in Discussions
#3
This is going to repeat some of what Yodon said, but if you are looking for an outline for design verification protocols, here is one:

Title page typically includes items like author, document title, number, revision, date, project reference.
Purpose
Describes why the test is being done​
Scope
Describes context like the project number​
References
Provides references to applicable standards, project documents, quality system documents, etc.​
Background
Provides additional context as needed and futher information regarding the device or why this test is needed​
Test Article Identification
Describes whether the final device is used for testing or a modified device or subassembly. Provides rational for the test article. Provides model number, part number, etc.​
Material/Equipment
Describes all materials and equipment to be used for the test.​
Sample Size
Provides the sample sized used and justification, including statistical rational. Justification typically ties back to the risk analysis.​
Method
Describes what will be done in detail.​
Acceptance Criteria
Provides specifications that must be met to demonstrate that design output meets input requirements. For clear traceability, the product requirement reference (like a number reference if assigned) may be added.​
Results
Describes how test results will be documented and how the data will be analyzed and compiled into a final report.​
Appendix
If data forms are used, they are provided here.​
The resulting report will be in a similar format with wording changed to past tense. The lot numbers of the test articles will be used, the data analysis and results and raw data will be included. There will be a final conclusion with a statement regarding whether the test passed or failed and whether there were devations to the method and justification for why there are okay.

Hope it helps.
 
Thread starter Similar threads Forum Replies Date
M Requirements, Verification Protocol and Reports All in One Document Design and Development of Products and Processes 6
S Calibration/Verification of customer fixtures IATF 16949 - Automotive Quality Systems Standard 4
Q Calibration verification records 7.1.5.2.1 IATF 16949 - Automotive Quality Systems Standard 2
B AS9100D 7.1.5.2 Calibration or Verification Method using outside cal lab AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
M ISO14971:2019 - Verification of implementation and effectiveness of risk control ISO 14971 - Medical Device Risk Management 3
C Stress / Challenge Conditions for Design Verification Testing to Reduce Sample Size 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
Q Sampling method for Distributor verification activities EU Medical Device Regulations 1
D Design Verification Sample Size vs Repeats Statistical Analysis Tools, Techniques and SPC 9
S IEC 62304 - Software verification cost IEC 62304 - Medical Device Software Life Cycle Processes 3
T Laboratory Verification after validation ISO 17025 related Discussions 3
D ISO 13485 - 7.3.6 Design and development verification - Do most folks create a separate SOP? ISO 13485:2016 - Medical Device Quality Management Systems 4
T Calibration or Verification -> Cm and Cmk, etc. Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
K IEC 62304 compliance - Code reviews as part of verification strategy IEC 62304 - Medical Device Software Life Cycle Processes 5
S Documenting Design Verification Test Results (ISO 9001) Design and Development of Products and Processes 1
C Documentation for items used for Design Verification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P Design verification driven by new equipment. How is this different than process validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
W Seeking Guidance Verification Test Strategy for Class B Medical Devices IEC 62304 - Medical Device Software Life Cycle Processes 1
NDesouza Verification of Supplier RCCAs Nonconformance and Corrective Action 5
I IATF 2016 - 8.5.1.4 Verification after shutdown due to COVID19 Process Maps, Process Mapping and Turtle Diagrams 1
M IATF 16949 8.5.1.3 Verification of job set-ups - Do we need secondary check? IATF 16949 - Automotive Quality Systems Standard 7
G Supplier flowdown verification of tests and revisions Supplier Quality Assurance and other Supplier Issues 0
G Devices from IQ, OQ or PQ process to be used for verification, validation and summative? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
M Calibration or Verification? What terminology to use ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Bev D Verification and Validation of Measurement Systems Misc. Quality Assurance and Business Systems Related Topics 0
A Our auditor told if we didn't have a patent we would have to do a validation or verification ISO 13485:2016 - Medical Device Quality Management Systems 6
N Design Verification & Process Validation - Statistical sample sizes Design and Development of Products and Processes 2
D Design Verification - Is testing required? Design and Development of Products and Processes 5
J Verification of purchased product / Alexa as a medical device ISO 13485:2016 - Medical Device Quality Management Systems 6
C Machine Verification Plan Manufacturing and Related Processes 2
A What to do when 100 % verification is not 100 % Manufacturing and Related Processes 5
R Design Verification Documentation ISO 13485:2016 - Medical Device Quality Management Systems 19
D 510K and Changes to Verification and Validation US Food and Drug Administration (FDA) 2
R Design verification for interim design outputs - sampling rationale ISO 13485:2016 - Medical Device Quality Management Systems 2
B Verification/release medical device modules Other ISO and International Standards and European Regulations 7
V Calibration certificate verification Qualification and Validation (including 21 CFR Part 11) 3
Ed Panek Label verification and validation US Food and Drug Administration (FDA) 5
D Testing to failure for design verification Reliability Analysis - Predictions, Testing and Standards 11
D Supplied item design verification Supplier Quality Assurance and other Supplier Issues 5
Ronen E A Rational Basis for Design Verification Design and Development of Products and Processes 5
V Which batches should or could be considered for design validation and design verification? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
R Supplier related drawings and verification of process requirements - Source Inspection AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
R Medical Device Design verification sample prototype Other Medical Device and Orthopedic Related Topics 14
I Medical device Validation/Verification template ISO 13485:2016 - Medical Device Quality Management Systems 1
G KPC & KCC verification and updates FMEA and Control Plans 15
APHX02 Thread Roll Process Verification w/in AS9100 (i.e. BSP-F-69/AS8879) Manufacturing and Related Processes 2
R Plan to Volvo Cars for capacity verification in Phase 3 of PPAP Customer and Company Specific Requirements 3
F AS9100 D - Verification of purchased product - Sheet metal and aluminum extrusion stock AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
Prashant G AS9100 Requirement - Verification of characteristics results with drawing requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 13
S Testing (Evaluation of) and Verification of Employee Color Vision Human Factors and Ergonomics in Engineering 19
G Assigning a calibration tolerance - An x-y coordinate machine - Uncertainty as my verification tolerance General Measurement Device and Calibration Topics 4

Similar threads

Top Bottom