Post Validation Sampling or not?

W

widmn

#1
I am getting an argument from some folks who believe that sampling after validation is unnecessary. After all, the process is validated. While I see that argument after some processes like sterilization (over-engineered process), I do not see that in general. I believe that validation "allows" you to sample versus just not sampling at all. What say the hive please? Please provide me with your arguments also. Thanks
 
Elsmar Forum Sponsor

TWA - not the airline

Trusted Information Resource
#3
Philosophical question in my opinion. I, too have heard people (mostly auditors) ask why we take samples for validated processes (Quote:"Doesn't that mean you do not trust your validation?"). For a lot of our processes I then answer "But I do trust the validation. It is just that we decided to retain samples in case of liability issues and when you do that anyway it's very easy to grab some more and test them..."
Generally I start out from risk management over to the control plan for the process and do exactly what I found to be neccessary to control the process and its risk. Sometimes it is more efficient and effectice to monitor a process by testing product samples rather then following a thousand different parameters.
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#4
Are you talking about 'special processes' or any process?

Even a special process that has been validated can have problems that are caused by factors not considered during the validation. Physics happens! It is always prudent to sample in some way to detect unforseen changes befroe your Customers do.

non-special processes are typically not as well characterized - they may only be validated via first article and functional testing. in theese cases teh probability of an unvalidated change that will effect your product is fairly high. I can't tell you how many processes within my cmopany and at my suppliers that have performed well for years and then some 'small' change happens and all heck breaks loose!

Trust but verify...continually
 

TWA - not the airline

Trusted Information Resource
#5
Physics happens!
Bev, that's so true. However in my experience (medical device) I see a lot of people who think that if you follow the regulations to the letter, your product will be totally safe and that "residual risk" is something like "you get poisoned by a guy who does not like your hair-do and therefore you are too slow to dodge the truck when you decide to cross a 6 lane highway during rush hour"...

BTW, I do not validate but always verify non-special processes.
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#6
I hear you. I am in the veterniary diagnostic device industry adn I hear the same thing - mostly from our R&D folks who are simply clueless in how manufacturing actually works (variation is a foreign concept to them :confused:) While this would happen in an ideal state - we are all far from ideal...

My Ops folks get this now but only becuase they've been burned so many times.

Curiously this 'belief' is persistant in many industries. Maybe this is why major Customers and the various standards 'mandate' validation and inspection sampling?
 
Thread starter Similar threads Forum Replies Date
S Verification and Validation of Post Market Design Change Design and Development of Products and Processes 2
C Change Control Forms Post Software Validation Medical Information Technology, Medical Software and Health Informatics 2
B ISO13485 Sterilisation Validation, Risk Management, Post Market Surveillance ISO 13485:2016 - Medical Device Quality Management Systems 13
thisby_ Post Market/Production Risk Assessment ISO 14971 - Medical Device Risk Management 0
dgrainger Informational MHRA - Regulating medical devices in the UK - Post Brexit - 2021-02 UK Medical Device Regulations 0
C Production and Post Production feedback - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 4
R Impact of changing manufacturer post clinical investigation CE Marking (Conformité Européene) / CB Scheme 3
N Post Market Surveillance Package Example Wanted ISO 13485:2016 - Medical Device Quality Management Systems 1
M Differences in post market safety reporting for Combination Product Applicants Medical Device and FDA Regulations and Standards News 1
K Product (Device) Life cycle - Product Life AFTER the Post Market Phase Medical Device and FDA Regulations and Standards News 3
M Status of Medical Device Regulations in UK Post-Brexit Other Medical Device Regulations World-Wide 10
M Post Market Surveillance for Class II Medical Devices Medical Device and FDA Regulations and Standards News 2
N Post registration variation to medical device Other Medical Device Regulations World-Wide 1
F Medical Devices - Hong Kong - Post approval changes regulation (China's MOH) Other Medical Device Regulations World-Wide 3
H Post-market surveillance strategy EU Medical Device Regulations 1
B Procedures for Complaint Handling and Post Market Surveillance EU Medical Device Regulations 7
A Post-market clinical followup studies (PMCF) EU Medical Device Regulations 16
Z Role of economic operators (EO) post the EU MDR Date of application in May 2020 EU Medical Device Regulations 1
M Informational Creating a post market surveillance (PMS) system for medical devices – Part 1 Medical Device and FDA Regulations and Standards News 7
E Post Market Surveillance Standard Various Other Specifications, Standards, and related Requirements 4
T Post-Market Surveillance Plan - Requirements outlined in Annex III (1.1b) EU Medical Device Regulations 2
Ashok sunder Is it possible to reduce Risk likelihood and impact Post control Ranking after corrective action taken for risk? FMEA and Control Plans 1
DuncanGibbons Why is 8.4 post-delivery activities before 8.6 release of products and services in AS9100D? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
Y Post Market Surveillance Indicators and Analysis method EU Medical Device Regulations 1
M Post Market Surveillance Plan Template EU Medical Device Regulations 10
F Vietnamese Post-Market Surveillance Requirements for a medical device in Japan Other Medical Device Regulations World-Wide 0
M PMCF (Post Market Clinical Followup)/ PSUR template EU Medical Device Regulations 8
S PMCF (Post Market Clinical Followup): Rationale for Exemption - Software Medical Devices EU Medical Device Regulations 6
S Post Market Surveillance and Annual Product Review in ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 2
K Post Market Clinical Follow up and CE Marking for Class IIb medical X-Ray products CE Marking (Conformité Européene) / CB Scheme 1
J Delete post - How to delete post? Elsmar Xenforo Forum Software Instructions and Help 8
M Medical Device News Health Canada Notice of intent: Strengthening the post-market surveillance and risk management Canada Medical Device Regulations 1
Marc User Post Counts - 20181101 Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 0
S Is management representative a temporary post or a job title Management Review Meetings and related Processes 16
A Return information production and post production ISO 13485:2016 - Medical Device Quality Management Systems 1
W Interesting Discussion PMCF (Post-Market Clinical Followup) vs PMCF studies EU Medical Device Regulations 36
K EU MDR - PMS (Post Market Surveillance) SOP - definition of "register(s)" EU Medical Device Regulations 2
S An auditor asked for a Post Market Surveillance Report ISO 14971 - Medical Device Risk Management 4
K Where does the FDA post its various compliance dates? US Food and Drug Administration (FDA) 2
T Proactive / Preventive Post Market Surveillance question ISO 13485:2016 - Medical Device Quality Management Systems 4
M ISO TR 20416 Medical Devices - Post-Market Surveillance for Manufacturers Other Medical Device Related Standards 6
B AS9100 Scope of Registration - Post-Delivery Activities N/A? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
S Merging Post Market Surveillance and Complaint Handling ISO 13485:2016 - Medical Device Quality Management Systems 3
K What can be considered a "Post Delivery Activity" (ISO 9001:2015 Clause 8.5) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
C PMCF (Post Market Clinical Followup) Enrollment Sizes (Spinal Implants) EU Medical Device Regulations 5
S Post Market Surveillance procedure/ SOP Medical devices Imported Legacy Blogs 0
A Production and Post-Production and Complaint Handling ISO 14971 - Medical Device Risk Management 2
A Post-market Clinical Studies of Orthopaedic (Revision) Implants EU Medical Device Regulations 1
A Industry best practice about Post-Market Surveillance and Risk Analysis ISO 14971 - Medical Device Risk Management 6
S Hi! First Post - New to AS9100 QMS Implementation AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9

Similar threads

Top Bottom