Verification or Validation for Glue Dispenser Units ?

G

GillianG

#1
Hi

I have to pull a plan together to validate / verify glue dispenser units for the bonding of various silicone joints to tubing. I will have 10 dispensers going into production for approximately 12 different joints / components. I'm trying to work out how best to approach this.

The dispenser is a constant flow of glue that the operator inserts the tubing into the glue "waterfall". I therefore cannot perform a capability analysis on the volume of glue dispensed. Also, all bonded components will be subject to 100% inspection post the bonding process.

Do I perform a TMV / Gage R&R on each component - 10 separate TMVs - to verify the bonding process is successful?
Once I've passed the TMV do I perform it on each dispenser or if they are all the same model can we "assume" (I know...) that the other dispensers will provide the same result?
Or do I perform a TMV on each dispenser using a different component for each one?

Thank you in advance for any help / guidance with this.
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
Re: Verification Studies for Glue Dispenser Units - Query.

Hello Gillian and welcome to the Cove :bigwave:

What does the 100% inspection consist of? Is it just a visual or do you also test for functionality (strength, sealing etc.)?

In principle, if a process is verified 100% there's no formal need to validate it. Doing both represents a redundancy and possibly wasted resources.

Cheers,
Ronen.
 
G

GillianG

#3
Hi RonenE

Thank you for your response. I agree 100% that this is a waste of time and energy. Historically we have not validated any of the processes we use for this bonding procedure as we 100% inspect - visual and functional. However, with the roll-out of the new dispensers, our customer is pushing for some form of validation. I therefore am trying to keep it as simple as possible. If we have 10 dispensers, can I perform a TMV on one and prove equivalency?
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Hi,

If it all comes from a customer requirement, and they're not too specific about it, you have more freedom as to the scope and method. I believe we're discussing a medical device, right? If so, I think that GR&R / Test Method Validation is less applicable, and instead you better relate to production process validation. It sounds as though you're trying to validate the production equipment, not the subsequent verification testing.

For guidance, you could look at the FDA's medical devices process validation guidance, and since you're not obliged by the regulation to do it, you could modify it to suit your needs. Perhaps an IQ and an OQ would suffice. You could create a protocol draft and see whether the customer is satisfied.

Addressing variability - if you can show that all 10 dispensers are made to the same specification you could probably get away with an IQ for all, an OQ for just one or two, and documenting equivalence. The more complicated part is that you use the dispensers for a range of different products. If that range can be divided into categories, you might be able to test just one representative product for each.

HTH
Ronen.
 
Last edited:

somashekar

Staff member
Super Moderator
#5
I see more to this than what I read. You have a scope here to address the complete process. What is the glue viscosity ? how do you measure and maintain it ? How much length of the tube does he wet under the glue 'waterfall'. How long he must hold the tube in the 'gluefall' for the complete wetting of the tube surface. Are there any controls for this., like a work holder or fixture ? You are talking about operator qualification as well as process validation (IQ / OQ / PQ).
 
Thread starter Similar threads Forum Replies Date
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
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
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 510K and Changes to Verification and Validation US Food and Drug Administration (FDA) 2
Ed Panek Label verification and validation US Food and Drug Administration (FDA) 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
I Medical device Validation/Verification template ISO 13485:2016 - Medical Device Quality Management Systems 1
M Does anyone has a good verification and validation plan template? ISO 13485:2016 - Medical Device Quality Management Systems 3
S Source of QMS templates including templates for design verification/design validation Document Control Systems, Procedures, Forms and Templates 2
Ed Panek Verification & Validation requirements - Patch that adheres to skin ISO 13485:2016 - Medical Device Quality Management Systems 2
M Bringing blending in-house - Verification or full validation? (Disinfectants) ISO 13485:2016 - Medical Device Quality Management Systems 3
A Level of details required for Class IIb Product Verification and Validation CE Marking (Conformité Européene) / CB Scheme 1
S CE Mark Approval Design Verification and Validation Questions CE Marking (Conformité Européene) / CB Scheme 8
S What is the difference between Verification and Validation of Test Reports? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
M IEC 62366-1:2015 Usability Verification / Validation Plan example wanted IEC 62366 - Medical Device Usability Engineering 20
shimonv System Verification & Validation in HC Class III Submission Canada Medical Device Regulations 2
T Validation and Verification - Catheter into a tyvek pouch ISO 13485:2016 - Medical Device Quality Management Systems 2
D User Requirements Tracing - Verification and Validation Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Validation before Verification. Why not? ISO 13485:2016 - Medical Device Quality Management Systems 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
E How to write requirements for Medical App Validation and Verification IEC 62366 - Medical Device Usability Engineering 7
Chennaiite Cause Analysis for Verification/Validation Failures - Seeking Opinions Problem Solving, Root Cause Fault and Failure Analysis 3
F Usability Objectives and Verification & Validation Plan IEC 62366 - Medical Device Usability Engineering 6
S Verification and Validation of Post Market Design Change Design and Development of Products and Processes 2
M Validation/Verification Trace matrix - examples or recipe? Document Control Systems, Procedures, Forms and Templates 1
T Class II Software Device 510k V&V (Verification and Validation) Criteria and Results 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
V Utility (power production) Company - Mitigating risks in Verification and Validation. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
A Should the FSMS have a Documented Generic Procedure for Verification and Validation Food Safety - ISO 22000, HACCP (21 CFR 120) 2
P What is Validation, Verification and Improvement of FSMS in ISO 22000 Clause 8? Food Safety - ISO 22000, HACCP (21 CFR 120) 2
P How to separate Product Design Review, Verification, and Validation Activities ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
T Medical Device Software Verification & Validation for Client Specific Configurations Design and Development of Products and Processes 2
Q Verification & Validation Project Time Line Qualification and Validation (including 21 CFR Part 11) 5
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
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
A Does the V&V (Verification and Validation) belong to Bench Testing for 510k? Qualification and Validation (including 21 CFR Part 11) 2
K Verification, Validation or Checking? Definition of the word "Checked" Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
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
T Definition Verification and Validation Definitions and Differences Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 9
Chennaiite Prototype - Design Verification or Validation? APQP and PPAP 12
I Cumulative Confidence Levels - Design Verification and Validation Sampling Inspection, Prints (Drawings), Testing, Sampling and Related Topics 12
S Medical Device Software Verification and Validation Results - What is necessary? Software Quality Assurance 4
S Medical Device Design Verification and Validation - info Other Medical Device and Orthopedic Related Topics 1
AnaMariaVR2 Water Systems Verification and Validation, and ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
D Special 510k - Data Results of the Design Verification and Validation Other US Medical Device Regulations 3

Similar threads

Top Bottom