SBS - The best value in QMS software

When to Validate and when not to Validate

M

medical_eng

#21
#21
Hi Jscholen,

Yes, you hit the nail on the head! (IMHO) Your method of constructively addressing this type of situation seems quite appropriate.

Comments Illuminatus? Have things been resolved per your original post?

Thanks for the input jscholes :)

Cheers!
 
Quickly Organize an Intelligent TDP from DISCUS
Elsmar Forum Sponsor
M

MIREGMGR

#22
#22
As Ronen notes early in the thread, there is a confusion in this thread about the meaning of "verification".

Medical device regulators (generally) require that essentially every unit be assuredly compliant. A typical meaning for "essentially every" in a common medical process, i.e. sterilization, is assurance of compliance to at least a 10E-6 standard, i.e. an uncertainty of no worse than 1 in a million.

A process that "can be verified", or for which the first unit, the last unit and a few intermediate units are checked, hasn't been verified. Verification applies to each unit. You either do it for each unit, or that unit hasn't been verified.

Don't want to verify every unit? Validation is what you do to prove that your process is reliable and you don't need to verify every unit.

You can't say that you're verifying if you're only sample-checking. Not per the applicable medical device process standards, anyway.
 
J

jscholen

#23
#23
To clarify what FDA experienced folks have said in many parts of this thread:

Validation is about the assurance of a quality product.

Verification is about the assurance of a quality product, although 100% inspection poses its own challenges since its not reliable 100% of the time in cases where dependence is on a human inspection. (I might even argue that the inspection method needs to have some validation/qualification associated with it)

Sampling is about protection from a defective product. Its not reliable 100% of the time and their are risks of accepting defects.
 
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#24
#24
jscholen said:
To clarify what FDA experienced folks have said in many parts of this thread:

Validation is about the assurance of a quality product.

Verification is about the assurance of a quality product, although 100% inspection poses its own challenges since its not reliable 100% of the time in cases where dependence is on a human inspection. (I might even argue that the inspection method needs to have some validation/qualification associated with it)

Sampling is about protection from a defective product. Its not reliable 100% of the time and their are risks of accepting defects.
Click to expand...
Just to complete the picture - validation also doesn't provide 100% confidence in all cases. It is typically risk-based and probability-theory-based. Both these factors involve decisions and considerations taken by the planners through the process.

The only way to get 100.00% confidence is to refrain from making any products :lol:
 
M

medical_eng

#25
#25
Hmmmm, I guess I thought that if you had a proper statistically sound sampling plan with control charts, etc. that verification did not have to be each and every unit (100%). Perhaps I was mistaken. It would seem that the FDA is indeed looking for 100% verification inspection (not sampling) as noted by miregmgr and confirmed according to a FDA 483 warning letter to Hammill in January 2009.

I agree with Ronen (even if he partially jests), that validation is more or less statistical in nature and further IMHO it is therefore not 100% 'bulletproof' either.

Anyway, assuming that the correlation between product output and process settings is well characterized through a good process validation study, does this mean that you have to have real-time, 100% monitoring of the process then? Taking this thought further, is it true that at the end of the day you supposedly want confidence that if there was even only 1 bad (off spec.) item produced that it was either culled or the lot rejected (or other appropriate reaction plan)?

Cheers!
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
L How to determine / validate Medical Device Storage Conditions ISO 13485:2016 - Medical Device Quality Management Systems 1
Anonymous16-2 21 CFR Part 11 - Steps to take if we want to validate an electronic system Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
T How to “validate/qualify” a new measurement equipment? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
R Validation of Medical Device Hardware containing Software - How many to Validate ISO 13485:2016 - Medical Device Quality Management Systems 1
S Do we need to validate Software used in Drug discovery and development process? Qualification and Validation (including 21 CFR Part 11) 2
kisxena Memo to File - Failure to Validate Supply Chain Security Management Systems 1
A ISO 13485:2016 - Validate our use of software that impacts on the QMS ISO 13485:2016 - Medical Device Quality Management Systems 8
A Process to Validate the Accuracy of Test Reports (AS9100) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 38
C Do we need to Validate Off the Shelf Software? Manufacturing and Related Processes 5
M How to validate hundreds or even thousands of parts? Qualification and Validation (including 21 CFR Part 11) 7
B How to validate Microsoft Excel Spreadsheet Calculations for the Cpk value Capability, Accuracy and Stability - Processes, Machines, etc. 9
M How to validate a system to make it compliant with 21 CFR Part 11 Qualification and Validation (including 21 CFR Part 11) 2
B Do I need to validate my database software? Calibration and Metrology Software and Hardware 1
K COTS Validation: Should we validate Windows after each Update? IEC 62304 - Medical Device Software Life Cycle Processes 3
S How to validate a homegrown software 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
A How to verify and validate the effectiveness of CAPA with regards to employees ? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
A When to verify and when to validate Design Changes 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
H How To Validate Electronic Part From Non Authorized Distributor Process Maps, Process Mapping and Turtle Diagrams 7
G Prototype Manufacturing Equipment - Validate or not to validate? Quality Manager and Management Related Issues 2
S How to validate Device Shelf Life? CE Marking (Conformité Européene) / CB Scheme 8
M Destructive VTMV Subgroups - A Destructive Variable Test Method to Validate Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 11
M How to validate a Dye Test method used to evaluate Package Integrity Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 8
C How do you Validate Solderability of Components Prior to Soldering Operations Manufacturing and Related Processes 5
M Welding - to Validate or Not? If so, How? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
V Do we need to Validate a Server/Back-End System? Qualification and Validation (including 21 CFR Part 11) 2
I Using validated SAS JMP to validate Excel for Statistical Analysis? Qualification and Validation (including 21 CFR Part 11) 11
E How to Validate Master Equipment that has been brought to onsite General Measurement Device and Calibration Topics 12
E When to Validate a Process - 21 CFR Part 820.75.(a) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
R How to bond PVC (Tygon) Tubing and Validate the Process ISO 13485:2016 - Medical Device Quality Management Systems 13
T Do I need to validate a basic Excel spreadsheet Quality Assurance and Compliance Software Tools and Solutions 10
R Process Validation - Adhesive Bonding, what to validate and how? Qualification and Validation (including 21 CFR Part 11) 10
N How to Validate a Gage R&R Spread Sheet General Measurement Device and Calibration Topics 3
A How to Validate Effectiveness of Mitigations? ISO 14971 - Medical Device Risk Management 13
C Validate the idea of a Composite Performance Index Quality Tools, Improvement and Analysis 4
M How to determine/validate the "REQUIRED MANPOWER" in an office environment? Service Industry Specific Topics 4
R How to Validate Vision Inspection Systems Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
C Third-party lab needed to validate cleaning & disinfection? EU Medical Device Regulations 12
Proud Liberal How to validate the geometry of a 8 mm pitch, 22 tooth Gates HTD sprocket Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
T How does a tool-shop validate molds? Verification vs. Validation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
D Validate 99.5% reliability 90% confidence - Sample size calculation Reliability Analysis - Predictions, Testing and Standards 4
J Protocol to validate the use of Electronic Records like DHRs, NCMRs, Validations ISO 13485:2016 - Medical Device Quality Management Systems 3
N Periodically validate test reports for raw material - AS9100 7.4.3 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 15
V Calibration of a Digital Vernier - Need to check/calibrate/validate all 3 functions? General Measurement Device and Calibration Topics 9
P Last-off-part comparison used to validate the set-up (TS16949 Clause 7.5.1.3) IATF 16949 - Automotive Quality Systems Standard 3
E How to validate product if gage is determined out of calibration Document Control Systems, Procedures, Forms and Templates 19
M Digital Filling System - What do I need to Validate Here? Software Quality Assurance 1
M Seat Cover Product Validation for PPAP - How can I validate my product? APQP and PPAP 12
N Do we need to Validate Outsouced Processes? ISO13485 ISO 13485:2016 - Medical Device Quality Management Systems 12
E GMW3172 - Thermal Shock and PTC cycles required to validate an electronic system Reliability Analysis - Predictions, Testing and Standards 2
A Software Observation during ISO 9001 Audit - Validate and Re-validate Software ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13

Similar threads

Top Bottom