Loss of a Quality Record - FDA Inspection

#1
Hello Elmar Forum :)

I am looking for guidance.
We are currently going through an FDA Audit for Medical Devices and we cannot locate a CAPA from 2016. I see in 820.180 the mention of storage to minimize deterioration and to prevent loss but I do not see anywhere about what to do if you lose a record.
Currently my record retention procedure does not reflect this either.

HELP PLEASE!

Vicki
 
Elsmar Forum Sponsor

craiglab

Involved In Discussions
#2
Hi Vicki. The QMS is to be designed to maintain control and losing a CAPA is akin to losing control. For recreating the CAPA you might want to look at previous quality/management reviews, internal audits, places where actions already taken are documented (like an ECO), etc.). And open a CAPA to investigate and correct this deficiency in your document control process. I would not be concerned with a process to follow since this should be a rare exception - do what you can and document with a note to file.
 

shimonv

Trusted Information Resource
#3
Hi Vicky,
If you cannot find the hard copy or the soft copy of a particular CAPA record it may be that it was cancelled. Do some research into it.
Another path to follow: talk to the IT department and retrieve a backup of 2016 QA folders. You should be able to find it if it was filled and executed.

Good luck with the audit.

Shimon
 
#4
Hi Vicki. The QMS is to be designed to maintain control and losing a CAPA is akin to losing control. For recreating the CAPA you might want to look at previous quality/management reviews, internal audits, places where actions already taken are documented (like an ECO), etc.). And open a CAPA to investigate and correct this deficiency in your document control process. I would not be concerned with a process to follow since this should be a rare exception - do what you can and document with a note to file.
Thanks craiglab, this was helpful. We were able to produce about 95% of the documents however they were not signed. He reviewed them and was ok because all of our other documents had no issues. I will take your advice and open a CAPA to address our deficiencies. Thanks again!!
 
#5
Hi Vicky,
If you cannot find the hard copy or the soft copy of a particular CAPA record it may be that it was cancelled. Do some research into it.
Another path to follow: talk to the IT department and retrieve a backup of 2016 QA folders. You should be able to find it if it was filled and executed.

Good luck with the audit.

Shimon
I had saved a lot of the information in a folder and was able to reprint. We were also able to show that it had been reviewed during a ISO audit and during our management review which saved us a 483. : )
Thanks for your help!
 
Thread starter Similar threads Forum Replies Date
M How far does one go to protect quality and other records from "loss" Records and Data - Quality, Legal and Other Evidence 1
Geoff Cotton Taguchi quality loss function - How do I establish the 'Consumer Loss' element? Quality Tools, Improvement and Analysis 6
E Received a Major finding during IATF Surveillance audit for loss of BIQS Level 3 (more than 6 SPPS in 6 months)...how should we address SYSTEMIC CA? IATF 16949 - Automotive Quality Systems Standard 11
M Informational FDA discussion paper – Consideration of Benefit-Risk Approaches for Weight-Loss Devices Medical Device and FDA Regulations and Standards News 0
H 8.4.2.4.1 Supplier Audit - Supplier with IATF certified loss IATF 16949 - Automotive Quality Systems Standard 4
BradM Sympathy to Wes Bucey and his family, loss of his wife Coffee Break and Water Cooler Discussions 20
Q Loss of Personnel - Root Cause Analysis ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
E Risk Analysis - Events which may cause to Data Loss ISO 14971 - Medical Device Risk Management 12
M Taguchi Loss Function Problem Misc. Quality Assurance and Business Systems Related Topics 2
RoxaneB Fighting Corporate Memory Loss Training - Internal, External, Online and Distance Learning 7
T Calibration Laboratory Temperature/Humidity goes out of tolerance due to Power Loss General Measurement Device and Calibration Topics 9
V Monitoring Specific Reasons and Categories of Yield Loss of Online Rejects ISO 13485:2016 - Medical Device Quality Management Systems 1
E US FDA Blood Loss Policy - Dislodged Hemodialysis Needle Other US Medical Device Regulations 3
Randy Loss of gravitational attraction (Weight loss for you PhD's) Coffee Break and Water Cooler Discussions 29
C Assembly Line Organization 17% Startup Loss - SMED (LCD TVs) Lean in Manufacturing and Service Industries 3
Marc Taguchi Loss Function example Misc. Quality Assurance and Business Systems Related Topics 4
S Incidence of Loss of Competency - Departure of a Knowledgable Employee Misc. Quality Assurance and Business Systems Related Topics 10
G Implementing Taguchi Loss Function in COQ - A Curious Case Misc. Quality Assurance and Business Systems Related Topics 1
M "Pet Project" Improvements - At a loss Lean in Manufacturing and Service Industries 23
Chennaiite What is the loss? A guy buys a chocolate from a shop worth 80 YEN Brain Teasers and Puzzles 20
bobdoering Toyota forecasts $8.6B loss, says 1 million sales will vanish World News 2
chris1price Loss of CE Mark - MHRA decided that they are not Medical Devices EU Medical Device Regulations 10
Jim Wynne GM Posts $15.5 Billion Second-Quarter Loss World News 0
K Cost Estimation of Sand Casting Process including the Pig Loss in estimation Manufacturing and Related Processes 7
H Rolled Throughput Yield (RTY) Loss - Can you measure in PPM? Six Sigma 3
Marc Ford posts its worst loss in history World News 8
Marc Ford Reports Loss of $5.8 Billion in 3rd Quarter World News 0
Marc Ford Has $1.19 Bln 1st-Qtr Loss on Job-Cutting Costs World News 15
Marc GM tried to mask its billion-dollar third-quarter loss with bright news World News 15
Marc The Loss of Manufacturing Jobs since 1999 - Will Unions make a Come Back in the US? Philosophy, Gurus, Innovation and Evolution 24
Marc GM plunges into $1bn quarterly loss World News 28
M ASTM Method for Light Loss Testing - Enclosures for the CCTV industry Various Other Specifications, Standards, and related Requirements 4
M Monetary Loss due to NonConformances - Who is liable? Nonconformance and Corrective Action 11
D Loss Prevention in ISO 9001:2000 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Marc Zero Defects & Taguchi Loss Function - ISO 9000 and the Zero Defects Philosophy Quality Tools, Improvement and Analysis 32
M Quality Metrics Questions Lean in Manufacturing and Service Industries 2
F Quality manual for trading company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 0
John Broomfield Informational Terms used in quality management [Deleted] Misc. Quality Assurance and Business Systems Related Topics 6
D Imaging/Image Quality Standards Other Medical Device Related Standards 1
D Quality Team Structure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
V Quality Objectives - ISO 9001 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
E Best way to keep up with pharmaceutical quality knowledge and current affairs Service Industry Specific Topics 1
C Quality assurance in Pharmacovigilance Document Control Systems, Procedures, Forms and Templates 0
I Quality Policy and Objectives examples Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 4
Miner Quality checks of product QR codes FMEA and Control Plans 2
S ISO 13485 Lead Auditor - Debate between our Quality Team and Regulatory Auditor - Internal Auditor Training ISO 13485:2016 - Medical Device Quality Management Systems 15
M Operational (free) simulation games for manufacturing and quality Lean in Manufacturing and Service Industries 5
I Help: QFD House of Quality Quality Tools, Improvement and Analysis 1
F Risk for Quality Assurance Department in a Hospital - Hospital Incident Reporting ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
I New to LEAN but not to Quality - How to run Kaizen events Lean in Manufacturing and Service Industries 1
Similar threads


















































Top Bottom