Design Verification Testing and Statistics

#1
When it comes to design verification testing of a medical devices, a justification of sample size is required. If I need to verify outer diameter for example, typically I would use a minimum sample size of 15 and claim a 95% confidence level with a 90% reliability/conformance level of variable data (assuming normal dist.). But what if we are measuring 100% of the samples in production to verify that the diameter is with in a specification of 2.0mm +/- 10%. When production gives me the samples for testing I already know they are in specification. So do I still have to do design verification testing using relaibility statistics? Doesn't seem to make sense. What type of analysis of the data set do I say I'm going to perform in my protocol? The testing of the diameter is still required according to the regulations.
 
Elsmar Forum Sponsor

Tidge

Trusted Information Resource
#2
In the case of a measurement like you describe, you are doing a variable study as opposed to an attribute study.
 

Semoi

Involved In Discussions
#3
If you verify each product, you don't have to validate the production process. However, it might be useful to perform a gauge R&R study and to validate the measurement device -- as always everything depends on your risk assessment (FMEA). Performing the gauge RR study you are able to estimate how reliable you are able to measure the diameter.
 

yodon

Leader
Super Moderator
#4
As @Semoi indicates, it sounds like you're conflating design verification with process validation.

Your design verification is (can be) that the drawings show the right dimensions. Your process validations will determine if you're actually holding to the tolerances indicated.
 
Thread starter Similar threads Forum Replies Date
J Managing design verification regression testing of design changes Design and Development of Products and Processes 1
C Stress / Challenge Conditions for Design Verification Testing to Reduce Sample Size 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
D Design Verification - Is testing required? Design and Development of Products and Processes 5
D Testing to failure for design verification Reliability Analysis - Predictions, Testing and Standards 11
A Sample Size for Design Verification (Prototype Testing) for Medical Devices Qualification and Validation (including 21 CFR Part 11) 12
A Medical Device Design Verification Testing - Is ISO 62366:2008 what I'm looking for? IEC 62366 - Medical Device Usability Engineering 16
G Calculating Ppk for Design Verification - Variable Sampling Design and Development of Products and Processes 15
C Items used for Design Verification Design and Development of Products and Processes 7
N Example for design and development planning,input,output,review,verification,validation and transfer Misc. Quality Assurance and Business Systems Related Topics 4
D Design Verification Sample Size vs Repeats Statistical Analysis Tools, Techniques and SPC 9
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 6
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
N Design Verification & Process Validation - Statistical sample sizes Design and Development of Products and Processes 2
R Design Verification Documentation ISO 13485:2016 - Medical Device Quality Management Systems 19
R Design verification for interim design outputs - sampling rationale ISO 13485:2016 - Medical Device Quality Management Systems 2
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 Medical Device Design verification sample prototype Other Medical Device and Orthopedic Related Topics 14
E Sample size for design verification of variable in single use device Design and Development of Products and Processes 20
S Source of QMS templates including templates for design verification/design validation Document Control Systems, Procedures, Forms and Templates 2
C Deviation in Design verification Other Medical Device Related Standards 6
V Using K-Factor(Tolerance Interval) Analysis for Design Verification Statistical Analysis Tools, Techniques and SPC 3
J Design Verification - Managing Changes Design and Development of Products and Processes 4
S CE Mark Approval Design Verification and Validation Questions CE Marking (Conformité Européene) / CB Scheme 8
V Template / format for Device History File & Design Verification of transdermal patch 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
H Is design verification and validation required for samples accompanying the quotes ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
D Pre-Design Verification - Using Continuous / Variables Data Statistical Analysis Tools, Techniques and SPC 2
W Qualification of Design Verification Equipment 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
P ISO9001 Scope Exclusion Verification in a Design Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
M Design Verification: "Difference" in Sample Size Calculations? Design and Development of Products and Processes 1
S Verification and Validation of Post Market Design Change Design and Development of Products and Processes 2
H Form that will satisfy Design Review and Design Verification Requirements (7.3) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
J Design Inputs and Verification Activities CE Marking (Conformité Européene) / CB Scheme 5
R Need help on defining scope for Design Verification File for Class III IVD 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
smryan Satisfying the ISO 9001:2008 7.3.5 Design & Development Verification requirement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
P How to separate Product Design Review, Verification, and Validation Activities ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
Uriel Alejandro Trouble with a Mechanical Design Technical Verification Check List AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M Design and Development Outputs Approval, Verification and Validation IATF 16949 - Automotive Quality Systems Standard 4
A ?820.30(d) Design Output Release - Before or After Verification? Design and Development of Products and Processes 6
T DVP&R (Design Verification Plan and Report) for Vehicle Labels? APQP and PPAP 3
W Design History Verification Records Control and Approvals US Food and Drug Administration (FDA) 3
G Legacy Product - Do we need follow QSR 820? Design Verification and Validation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 12
S Design and Development - Review vs. Verification vs. Validation Design and Development of Products and Processes 15
S Acceptance Criteria at Design Verification Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
G Sample Size for Design Verification and Validation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
Chennaiite Is Design Verification Software required to be Calibrated IATF 16949 - Automotive Quality Systems Standard 7
B Is Ship Test considered Design Verification or Design Validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2

Similar threads

Top Bottom