Is Design Validation required for fixtures or test systems used to manufacture a product?

J

Jeff_N

#1
When designing a fixture or test system used in the manufacturing process for a product, is Design Validation required for that fixture or test system? (note, I realize that process validation will occur, which would involve evaluation of these items, I'm specifically asking if Design Validation is required in accordance to AS9100 and/or ISO 9001.
 
Elsmar Forum Sponsor
J

Jeff_N

#3
Right, so I should have clarified a little more. Assuming you are not selling this fixture outside of your own company. Thus, the 'users' of this fixture are trained/qualified by your company.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#4
If the fixture is not a deliverable item and, thus, not a “product”, there is no requirement in those two standards for the validation of the fixture design. As you said yourself the manufacturing process will be validated as per first article (for AS9100), but no fixture design controls are imposed.
 
#5
Just to amplify:

8.5.1.3 . . . The organization shall use a representative item from the first production run of a new part or assembly to verify that the production processes, production documentation, and tooling are able to produce parts and assembles that meet requirements . . .

May I stress TOOLING. In the broad sense, tooling includes fixturing.
 
Thread starter Similar threads Forum Replies Date
L Why is initial production units, lots, or batches, or their equivalents required for Design Validation? US Food and Drug Administration (FDA) 3
S Is Human Factor Testing required as part of Design Control Validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
H Is design verification and validation required for samples accompanying the quotes ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
H Required skills for Automotive R&D Electronic / Electrical design validation Design and Development of Products and Processes 1
E DESIGN VALIDATION, USABILITY AND CLINICAL EVALUATION request Medical Device and FDA Regulations and Standards News 0
Watchcat Software validation vs design V&V? Other US Medical Device Regulations 27
N Example for design and development planning,input,output,review,verification,validation and transfer Misc. Quality Assurance and Business Systems Related Topics 4
M API 4F/7K/8C Design Package Validation Oil and Gas Industry Standards and Regulations 2
D Test summary report example for design validation wanted - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
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
K Old medical devices -> 7.3.7. Design and development validation ISO 13485:2016 - Medical Device Quality Management Systems 1
N Design Verification & Process Validation - Statistical sample sizes Design and Development of Products and Processes 2
C Design Transfer Review - Before or after PQ validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 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
T Sample Size for Design Validation Design and Development of Products and Processes 4
P Performance evaluation (IVDD Annex VIII) & Design and Development Validation Studies EU Medical Device Regulations 1
S Source of QMS templates including templates for design verification/design validation Document Control Systems, Procedures, Forms and Templates 2
W Design and Process Validation - Different? ISO 13485:2016 - Medical Device Quality Management Systems 6
C Partial Design Validation and changes to a critical supplier 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
N Design Validation Conventions for Design History Files 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
S CE Mark Approval Design Verification and Validation Questions CE Marking (Conformité Européene) / CB Scheme 8
J Design Control - Can Validation be based on a limited/first Production Run ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C MSA for Non Manufacturing - Design Validation, Characterization and Qualification Lab Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
N How to perfom Design Validation for Road Designs Design and Development of Products and Processes 14
J Where does process validation fit within design & development? Design and Development of Products and Processes 7
T ISO 9001 - Design Validation Record exemption ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
A Products for Design Validation - FDA Requirements US Food and Drug Administration (FDA) 3
S Can anyone provide an example of Design Validation Protocol and Report? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S Verification and Validation of Post Market Design Change Design and Development of Products and Processes 2
A Determination of Production Equivalence for Design Validation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Chennaiite How to Measure Effectiveness of the Design Validation Process? Design and Development of Products and Processes 7
A Finishing Design Validation per 21 CFR Part 820 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
K Medical Device Design Validation vs Clinical Evaluation ISO 13485:2016 - Medical Device Quality Management Systems 5
M Design and Development Validation at the Customer's Location Document Control Systems, Procedures, Forms and Templates 5
P How to separate Product Design Review, Verification, and Validation Activities ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
M Design and Development Outputs Approval, Verification and Validation IATF 16949 - Automotive Quality Systems Standard 4
G Legacy Product - Do we need follow QSR 820? Design Verification and Validation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 12
A How to do Medical Device Design Validation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
S Design and Development - Review vs. Verification vs. Validation Design and Development of Products and Processes 15
G Sample Size for Design Verification and Validation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
L Design Validation Process Owner - Who should be the process owner of validation? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
B Is Ship Test considered Design Verification or Design Validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
D Design Input/Output and Design V&V (Verification and Validation) Interpretations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 14
D Medical Device Design Verification and Validation Differences 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 16
Chennaiite Prototype - Design Verification or Validation? APQP and PPAP 12
B Validation of DoE (Design of Experiements) Model - Minitab 15 Using Minitab Software 3
T Design Validation - Justifiable Exclusion for an Electrical Engineering Consultancy Design and Development of Products and Processes 11
I Cumulative Confidence Levels - Design Verification and Validation Sampling Inspection, Prints (Drawings), Testing, Sampling and Related Topics 12
B Sample Sizes for In-Vivo Design Validation Testing Other Medical Device and Orthopedic Related Topics 1
S Medical Device Design Verification and Validation - info Other Medical Device and Orthopedic Related Topics 1

Similar threads

Top Bottom