When is an issue a CAPA (Corrective and Preventive Action) request?

P

Plowmaster

#1
I work in start ups (medical device) There is always a bit of an art to deciding what goes into the CAPA system and what doesn't. Often when an issue is seen as more as a 'development' issue it will be part of development. (And if you have worked in start ups, you'll know every single one is manufacturing and developing at the same time as they push scale up)

So, If you created a CAPA procedure for a company that doesn't have a full QMS in place yet. (Also in start ups, its not that quality activity isnt going on, the efforts are just in islands. Everyone is resource constrained and often by the time you hear of a problem, the 'experts' have created a solution and moved on.) How would you define guidelines for when an issue should be a CAPA given a rapid development environment.

Thanks,

-K
 
Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#2
I work in start ups (medical device) There is always a bit of an art to deciding what goes into the CAPA system and what doesn't. Often when an issue is seen as more as a 'development' issue it will be part of development. (And if you have worked in start ups, you'll know every single one is manufacturing and developing at the same time as they push scale up)

So, If you created a CAPA procedure for a company that doesn't have a full QMS in place yet. (Also in start ups, its not that quality activity isnt going on, the efforts are just in islands. Everyone is resource constrained and often by the time you hear of a problem, the 'experts' have created a solution and moved on.) How would you define guidelines for when an issue should be a CAPA given a rapid development environment.

Thanks,

-K
Can someone with Medical Device expertise help?

Thank you!!

Stijloor.
 

somashekar

Staff member
Super Moderator
#3
I work in start ups (medical device) There is always a bit of an art to deciding what goes into the CAPA system and what doesn't. Often when an issue is seen as more as a 'development' issue it will be part of development. (And if you have worked in start ups, you'll know every single one is manufacturing and developing at the same time as they push scale up)

So, If you created a CAPA procedure for a company that doesn't have a full QMS in place yet. (Also in start ups, its not that quality activity isnt going on, the efforts are just in islands. Everyone is resource constrained and often by the time you hear of a problem, the 'experts' have created a solution and moved on.) How would you define guidelines for when an issue should be a CAPA given a rapid development environment.

Thanks,

-K
You have to differentiate which is the design and development changes in progress before the product release and after the product release.
A good design and development process will most certainly reduce the "issue" that you state.
Per ISO 13485, you have to establish a documented procedure for feedback system to provide early warnings of quality problems (which perhaps you term as issue) for input into CAPA process.
Typically you will also see that medical device version will undergo quick revisions when changes becomes necesary based on CAPA, and these CAPA gets triggered from early warnings. These are in situations when design processes fail., perhaps from the lack of complete design input or lack of design and development verification / validation ...
 
P

Plowmaster

#4
Thank you for the reply. Start - ups are still a slightly different animal, regardless of regulations or standards. None of them I have encountered have a 'Good design and development process' what they have is Project management with experts simply trying to get the next task done, and fix problems as they come up. Most start ups in silicon valley will do what it takes to get a 510(k) through. However, the state of the quality system will be very lacking and by the time they are scaling up there are a # of design changes to the product different than the submitted design in the 510(k). (As long the intended use doesn't change)

So in this evironment, the first thing I do is establish document control to start getting processes documented. Next the CAPA system but the are a myriad of issues, some go into CAPA and some don't, but it's a bit of an art to decide what goes in. Often, issues that would be a CAPA are solved before I even hear about it. (Solved on an immeadiate fix level, so it's no longer of interest given people have 1000 things to do and bandwidth for 100.) So if their first introduction to a QMS is simply something that slows them down, compliance is very low. You still have to teach the company at the same time and the QMS has to add value for people to proactively interact with it. (Unless its stict compliance, Authorative vs Tacit, but authorative often brings minimal compliance)

So, I guess I'm seeking general thoughts, what kind of criteria / guidelines would you write into your CAPA procedure as to when something should be submitted for CAPA. Right now, I review each issue and make a decision on each one. It would be nice to have a published set of guidelines. (Although admittedly, this doesn't garantee anything, but none the less would be helpful when management asks: What goes in to the CAPA system and what doesn't)

Thanks,

-K
 

somashekar

Staff member
Super Moderator
#5
some go into CAPA and some don't, but it's a bit of an art to decide what goes in. Often, issues that would be a CAPA are solved before I even hear about it.
The art is to be sensitive to pick those which are systamatic in nature and which can potentially repeat (in sense you know that if you do not take some steps at some place, the problem will reappear)
This does not include blunders .....

Often, issues that would be a CAPA are solved before I even hear about it.
You did not hear them ... so there is nothing ... :cool: ;)
If you keep hearing similar issues time and again then it is systamatic.
What is systamatic can be analysed and a root cause can be found and then CAPA becomes effective.

:topic:
If your big fishing net is made of fine netting then you catch many small fishes as well. You cannot enjoy all of them when you want to fry them for your lunch. Let the netting be bigger and matching to the size of the net, so that the catch is big few and the fry is tasty and wholesome.
 

yodon

Staff member
Super Moderator
#6
Somashekar hit the nail on the head: use whatever filter you can to identify only systemic issues. Don't overwhelm the CAPA system with the normal issues you encounter during design. If you suspect that you may have systemic issues in design, use a separate issue tracking system to document them. You can then review the list to see if there are, indeed, any systemic issues. For example, after requirements are baselined, track the number of changes to the document(s). You might see a trend indicating that your requirements definition / review process is not sufficient. If your testers continue to find the same problem, there may be an issue with your CM process.

If it's too much a burden to have folks document such issues as they are found and corrected, maybe just meet with them informally to gather the data. Remember, the CAPA system is about fixing or improving the process.

Since you say you have each issue, consider sorting them into process-related categories. If you see one stack really growing, that's a pretty good indication that you have a systemic issue. If one stack only has a few, then it's likely that process is rather stable with only a few bumps along the way. As you start looking at the issues through process "glasses" I expect you'll start to see those trends and get a better idea of what should be a CAPA (candidate) versus what is just continuing to move through the normal development process.
 
P

Plowmaster

#7
Thanks for the input!

I'm doing more or less the things you have mentioned. I guess there is not a complete clear of simple way to answer the question I get 'So how do you decide what goes into a CAPA?' Part of it is genuine inquiry, as CAPA is a knew concept for some of the management. When you explain what it is, the lines are still fuzzy for them what goes in and what gets put on the watch list. I bascially put a lot of issues on the watch list and circle back around to see whats happened with the issue. The onesy twoesy of development I simply let the engineers / scientists solve and move on.

Thanks,

Kendal
 
Thread starter Similar threads Forum Replies Date
P Issue Tracking and CAPA (Corrective and Preventive Action) Management Nonconformance and Corrective Action 6
P When to issue a CAPA (corrective action preventive action)? US Food and Drug Administration (FDA) 11
M Issue a CAPA if there is a corrective action associated with a complaint? Preventive Action and Continuous Improvement 7
M Issue with CAPA system - Should Over Due CAs warrant a CAPA? Nonconformance and Corrective Action 17
K Best practices on the criteria to issue CAPA & expected response time? Preventive Action and Continuous Improvement 2
Ch00Ch00 Evaluate a process - Issue number Lean in Manufacturing and Service Industries 7
M MSA angle issue - Nylon parts using Aberlink 3D Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 0
P MedWatch Report from a hospital due to a quality issue US Food and Drug Administration (FDA) 5
Marc Media Gallery Issue? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 1
M "Issue & continuous improvement" columns in AIAG-VDA PFMEA form FMEA and Control Plans 4
R Do we need issue ECN (Engineering Change Notice) towards updated Material Specification? Design and Development of Products and Processes 2
R Problem solving activity - Three hours to fix the issue Manufacturing and Related Processes 15
I Reissuing documents due to missing version / issue numbers Document Control Systems, Procedures, Forms and Templates 3
Marc Fuel tank issue (FOD) hits Boeing’s 737 MAX - Feb 2020 World News 19
F Struggling with a root cause analysis - Customer Returns - Escape issue Problem Solving, Root Cause Fault and Failure Analysis 15
Ron Rompen 2D matrix issue - Parts (machined steel) returned from the customer Design and Development of Products and Processes 0
G PolyWorks Alignment Issue - How to align the part General Measurement Device and Calibration Topics 1
M Accredited Calibration Sevice Provider using computerized system to issue calibration certificate Qualification and Validation (including 21 CFR Part 11) 3
M Accredited Calibration Sevice Provider using computerized system to issue calibration certificate General Measurement Device and Calibration Topics 2
A External Auditor issue with Internal Audits Internal Auditing 7
V Every good documentation practice observation is an data integrity issue US Food and Drug Administration (FDA) 7
V What is the criteria to cite an good documentation practices observation as an data integrity related issue US Food and Drug Administration (FDA) 6
A Domain of the component (EASA CM No.: CM-SWCEH-001 Issue 01 Revision 02) Point 9.3.3 (Usage domain aspects) EASA and JAA Aviation Standards and Requirements 0
B How to reply NCR on ineffectiveness of corrective action during IATF external audit? This is repeated issue whereby some mistake was done. IATF 16949 - Automotive Quality Systems Standard 7
J Control of nonconforming product issue (AS91000) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
C TL-9000 Certifying Body Issue - Auditor failed to find an issue for 10 years TL 9000 Telecommunications Standard and QuEST 16
E Determining what is good and what is bad can be subjective - when is it a quality issue? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Ed Panek Sensitive Supplier Issue - Single source supplier ISO 13485:2016 - Medical Device Quality Management Systems 6
B NB won't issue CE Certificate or return phone calls CE Marking (Conformité Européene) / CB Scheme 3
A Drawing Issue with Supplier - xb file did not match that of the pdf drawing Nonconformance and Corrective Action 4
J MAG 6 and EASA Part-145 Issue 005. EASA and JAA Aviation Standards and Requirements 0
A ISO/IEC 27001 - Issue during implementation of system IEC 27001 - Information Security Management Systems (ISMS) 3
M Saturated salts issue - Humidity Chamber General Measurement Device and Calibration Topics 5
N Do I need to approach galvanized steel sheet flatness issue with DOE? Problem Solving, Root Cause Fault and Failure Analysis 9
Sidney Vianna ASQ apparently doesn't know ISO does not issue ISO 9001 certificates? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 4
D Can an AS9100 auditor issue an NCR a month after the audit? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
K Class II Medical Device Compatibility Issue - Removal or Market withdrawal? US Food and Drug Administration (FDA) 2
J Can you stock parts without an 8130 and issue one at time of sale? Federal Aviation Administration (FAA) Standards and Requirements 2
R How many Corrective Action Request can be Issued by DCMA for a single issue? Nonconformance and Corrective Action 2
K NCR or CA? We're taking any issue we have and saying its a nonconformance Nonconformance and Corrective Action 11
R DCMA QAR Service Issue - Resident Inspectors absent from the plant AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
R Wet Signature Document Attachments in SAP - Risk on Data Integrity issue? Records and Data - Quality, Legal and Other Evidence 6
Mikishots Definition Issue - "Issue" vs. "Risk" in ISO 9001:2015 and AS9100 Rev D (Definitions) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
F Power Cord Length Issue - Medical Device Electrical Safety IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
D Breach of Contract from Registrar (Auditor Payment Issue) Registrars and Notified Bodies 18
T EASA TAG Block 11 Status/Work issue Quality Manager and Management Related Issues 1
S Could I issue major finding for Inadequate Procedures Supplier Quality Assurance and other Supplier Issues 17
G IEC 60601-1-2 Sample Size issue Other Medical Device Related Standards 1
M Repeatability issue in Gage R&R study for inner diameter of a bushing Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 16
G Out of Dimensional Tolerance - MRB Audit Issue Nonconformance and Corrective Action 11

Similar threads

Top Bottom