Questions regarding process validation

Thread Attachment browser
D

duff999

Involved In Discussions
#1
#1
Can anyone help me at a very high level what is meant by this flowchart with regards to process validation.

What is meant by "is Process Output Verifiable" I am trying to understand my trigger to perfrom IQ, OQ, PQ but cant wrap my head around what would be a "Yes"

1600888401238.png
 
Paper to QMS ad
Elsmar Forum Sponsor
shimonv

shimonv

Trusted Information Resource
#2
#2
The phrase "Is the process output verifiable?" means can you be assured that the tasks were completed successfully without altering, damaging or or destroying the product. Some task can be 100% verifiable by visual inspection, measurements or some kind of jig or software tool.
Some tasks like sterilization, soldering, or sealing a pouch cannot be verified without damaging the product. For these you need process validation.

Shimon
 
D

duff999

Involved In Discussions
#3
#3
Thanks for the information Shimon. If we perform a QC check for every product at various stages throughout the process and all checks pass, is process validation required.
 
Ajit Basrur

Ajit Basrur

Staff member
Admin
#5
#5
duff999 said:
Thanks for the information Shimon. If we perform a QC check for every product at various stages throughout the process and all checks pass, is process validation required.
Click to expand...
Remember that the QC check is a "sample" and not "100% verifiable". As Shimon explained earlier, if you can not demonstrate 100% verification, the validation is required.
 
chris1price

chris1price

Trusted Information Resource
#7
#7
Almost certainly not, unless the CoA specifically referenced every individual product and covered every step in the process.

Also, don't forget that testing itself is a process, so your test method needs to be validated.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
K Two FDA questions regarding UDI (and potentially 803.52 MDR) Other US Medical Device Regulations 0
E Questions regarding Cpk Calculation - Should we be using LSL/USL or LCL/UCL? Capability, Accuracy and Stability - Processes, Machines, etc. 5
J NB Auditor Questions regarding the move of the company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
B Questions regarding Non-Conformance, Corrective Action and Preventive Action ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
E Basic questions regarding Nuclear Quality Assurance standards Various Other Specifications, Standards, and related Requirements 15
T Questions on ISO 10993-1 regarding listings of approved chrome plating alloys. Other ISO and International Standards and European Regulations 0
apestate Thread micrometer questions, discussion regarding MU and calibration. General Measurement Device and Calibration Topics 3
Hershal Questions regarding supply chain monitoring - Supplier monitoring group? Supplier Quality Assurance and other Supplier Issues 2
D Signature Matrix questions ISO 13485:2016 - Medical Device Quality Management Systems 4
D ECO (Engineering Change Order) process questions ISO 13485:2016 - Medical Device Quality Management Systems 7
C 8.5.1.1 Control of Equipment, Tools, and Software Programs - Questions about the extent of control of NC programs AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
D Rules for Paper Forms outside of an eQMS - 3 Questions (ISO 13485) Document Control Systems, Procedures, Forms and Templates 9
D Shipping and recall questions ISO 13485:2016 - Medical Device Quality Management Systems 2
M Quality Metrics Questions Lean in Manufacturing and Service Industries 2
K FDA Premarket Cybersecurity Guidance - 4 questions Other US Medical Device Regulations 5
A Some questions about voluntary consensus standards in traditional 510(k) submission US Food and Drug Administration (FDA) 6
T AMS2570E certification equipment questions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
Mr Roo ISO 9001 - 7.1.3 Infrastructure - questions concerning evidence ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
K AS9100 - 7.3 - Are these black and white questions with specific correct answers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
M Medical Device Identification & Codes - Article 27 Requirements questions EU Medical Device Regulations 1
Q Asset / Tooling Management - Two Questions Manufacturing and Related Processes 3
Q VDA 6.3 questions vs IATF 16949 clauses VDA Standards - Germany's Automotive Standards 0
I Questions to ask when auditing for Organizational Leadership and Planning for the QMS? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A ISO13485:2016 name and ownership changes questions ISO 13485:2016 - Medical Device Quality Management Systems 2
C CQA Test Questions Bank General Auditing Discussions 1
E Three basic questions about ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Informational EU – EMA revised guidance – Questions & Answers on Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 201 Medical Device and FDA Regulations and Standards News 2
M Informational EU – MDCG 2019-6 v2 Questions and answers: Requirements relating to notified bodies Medical Device and FDA Regulations and Standards News 0
Ed Panek Relevant questions on Substantial Change Form CE Marking (Conformité Européene) / CB Scheme 3
K Beginner in ISO 45001 here! Three questions Occupational Health & Safety Management Standards 6
D Framing FDA Questions - Validation US Food and Drug Administration (FDA) 1
M Informational US FDA – Frequently Asked Questions (FAQs) About the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Medical Device and FDA Regulations and Standards News 0
F Barcoding questions - Is there a plain English primer for newbies? ISO 13485:2016 - Medical Device Quality Management Systems 10
D Questions about the contents of a Design History File 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S ISO 14971 Risk Management - Questions for Hazard identification ISO 14971 - Medical Device Risk Management 2
M Informational EU – MDCG 2019-6 Questions and answers: Requirements relating to notified bodies Medical Device and FDA Regulations and Standards News 0
C MDR Importer/Distributor Definition Questions EU Medical Device Regulations 5
A Purchasing - Internal Audit Questions Internal Auditing 8
M Informational USFDA – Efforts to evaluate materials in medical devices to address potential safety questions Medical Device and FDA Regulations and Standards News 0
M Informational USFDA draft guidance – A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry Medical Device and FDA Regulations and Standards News 0
E Basic Risk based thinking questions Risk Management Principles and Generic Guidelines 5
F Job Travelers questions - unsigned operations AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 41
J Training documentation - ISO 13485 audit and the auditor had questions General Auditing Discussions 7
G Auditor watching tech do procedure - Can tech ask questions? ISO 17025 related Discussions 6
A Any recommendation for ASQ's CPGP (Pharmaceutical GMP Professional) Certification exam questions? ASQ - American Society for Quality 2
M Informational EU – Questions And Answers Related To The United Kingdom’s Withdrawal From The European Union With Regard To Industrial Products Medical Device and FDA Regulations and Standards News 0
F API Spec Q1 9th Edition Surveillance Audit - Questions about internal audits. Oil and Gas Industry Standards and Regulations 23
S SPC (Statistical Process Control) for Unilateral Tolerance - Questions Statistical Analysis Tools, Techniques and SPC 6
Ed Panek CE REP questions about our devices ROHS compliance REACH and RoHS Conversations 1
O Reinstating a disqualified supplier—questions to ask before making a decision Supplier Quality Assurance and other Supplier Issues 2

Similar threads

Top Bottom