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Corrective and Preventive Action
(CAPA)

COI‘v'ii'; 'i_l, .‘ . C&_'
: .E u « N ‘ —

 

Compliance Insight
5850 Boymel Dr. ...
Corrective and Preventive Action (CAPA)

1

Three Positions
- Proactive
- Reactive

- Interpretive

(, ‘0p_ right 3013
Corrective and Preventive Action (CAPA)

Corrective and
Preventive Action is a
primary focus of the
FDA during
inspections...
Some Regulations

ISO 9000

Corrective and Preventative Action - Section 4.14

The supplier should document detailed proce...
Some Regulations

ICH Q7 2.4 Internal Audits (Self Inspection)

“Aiidi/ findings and corrective actions should be
document...
Sonic Regulations

21 CFR Part 211.192

“A written record oftlre imestigatlion shall be made and
shall include the C()I7Cl...
Corrective and Preventive Action (CAPA)

The GMP regulation
has sections for

- complaints

- investigations

- deviations...
Corrective and Preventive Action (CAPA)

The purpose of these
sections is to have
problems come to the
attention of approp...
Corrective and Preventive Action (CAPA)
W‘ Typically,  some FDA
# enforcement action

prompted the focus for
a CAPA progra...
Corrective and Preventive Action (CAPA)

Success of CAPA
depends upon the
planning that goes into
it

 

Cop} right 3013 ll)
Corrective and Preventive Action (CAPA)

You are
Here

Questions to ask
yourselves -

   
 

.  Where do we really
stand? ...
Corrective and Preventive Action (CAPA)

When asked by the FDA
if your corrective actions
reflect findings by your
internal ...
Corrective and Preventive Action (CAPA)

lJ

DJ

Take into account
three points when
deciding the scope of
the plan

Cop_‘...
Corrective and Preventive Action (CAPA)

#1 Conduct a quality
system assessment

~ Independent,  detailed
evaluation of al...
Corrective and Preventive Action (CAPA)

#2 Utilize other

corporate sites
- Domestic
- International

 

( ‘op_riglil 201...
Corrective and Preventive Action (CAPA)

#3 Develop a
complete plan for the
CAPA program

- delegate work

~ support compa...
Corrective and Preventive Action (CAPA)

Other places you can
find information for
CAPA (Internal)
v Customer complaints
sl...
Corrective and Preventive Action (CAPA)

More places to find
CAPA information
(External)

v 483

v Warning Letter

,3 v You...
Corrective and Preventive Action (CAPA)

Four points to  / 

consider when _—I A
5 r ,  , *4

correcting problems
Copyrigh...
Corrective and Preventive Action (CAPA)

#1. Root Cause Determination

or A thorough understanding of
the entire situation...
Corrective and Preventive Action (CAPA)

#2 Determine scope
of the problem ‘
v This problem may be /1 I‘
indicative of iss...
Corrective and Preventive Action (CAPA)

#3 Prevent Recurrence

v Which system failed?   ’
— Thorough systemic ‘
examinati...
Corrective and Preventive Action (CAPA)

#4 Prevent Recurrence
at Corporate Level

-r Larger corporations
can support expe...
Corrective and Preventive Action (CAPA)

r A corporate system that
allows sharing _ 
consequential jj ,   
information and...
Corrective and Preventive Action (CAPA)

.  Remember the FDA
believes that one site
is part of the entire
company. 

r If ...
Corrective and Preventive Action (CAPA)

Q.  ‘ Utilize proper strategy

.  There can be no
“one size fits all”
approach

....
Corrective and Preventive Action (CAPA)

Executive Management

,  Effective CAPA
programs require
execufive
management to t...
Corrective and Preventive Action (CAPA)

v QA receives
progress reports
- Standing agenda item
— Require target dates
— Re...
Corrective and Preventive Action (CAPA)

v Site Meetings/ T raining
Explain CAPA and the
regulatory requirements
- Define ...
Corrective and Preventive Action (CAPA)

Management
delegates someone to
drive CAPA resolution

.  Typically,  this is the...
Corrective and Preventive Action (CAPA)

The driving forces

must prevent those

doing the work from _
distractions ‘T 1
T...
Corrective and Preventive Action (CAPA)

The driving forces
should be part of the
CAPA project
meetings. 

They can learn ...
Corrective and Preventive Action (CAPA)

The Right Strategy Q

.  You cannot have an
effective CAPA

process without a
str...
Corrective and Preventive Action (CAPA)

Common Failures of $(a

CAPA implementation 39 '

Lack of. .. F ‘
v Examination
....
Things to Consider About CAPA

r Successful execution of CAPA is highly
dependent upon the effectiveness of the
planning t...
Keep Calm

Establish a Plan of
Execufion
- Training
- Validation
~ Logistical Concerns
~ Regulatory Concerns
- Documentatio...
Effective Preparation

Form project teams

,  Find the right skills «e A
and experiences j»', ‘r , ,
1 Define roles ‘ '
— ...
CAPA Interaction Plan

v Written communication
plan — SOP or CAPA
specific

- Identifies all relevant
players

— Outlines ...
When Documenting CAPAs

Major Responsibilities . 
that are necessary
when documenting a
CAPA plan .  . . 

Warning - There...
In the details

CAPA writing
.  Specific Title
.  Avoid unnecessary descriptors

.  Dates/ times/ document names
and numbe...
Defining the CAPA

Define CAPA scope

.  Outline activities that
fall inside and outside
the scope

.  Must be defined earl...
Continuous Evaluation

.  Study problem
.  Determine extent
.  Establish root cause

.  Use a process flow
diagram of curre...
Updates to Procedures

Secure Approvals for
New/ Updated
Procedures
.  By this point,  there
should be no
surprises

Cop} ...
Proof of Execution

Assemble Documentation

I,  SOPs
tr Records

er Audits
. , Training

Copyriglil 3013

44
Change Management
0 ‘ 0

Control Process Q
0

.  Document Control
' U §

« Change Control

 

I ‘op_ riglit 3013
CAPA Meetings

Review Preparation
«r Review Project Team / 
,, Analyze CAPA I
Scope

er Examine Interaction
Plan

-r Revie...
Corrective and Preventive Action (CAPA)

Conduct Training
.  Who to train
o Who will do training
.  Training method
.  Eva...
Corrective and Preventive Action (CAPA)

Perform Internal
Review and Approvals
1 CAPA Project Teams

11 Final usually
perf...
Corrective and Preventive Action (CAPA)

Archive CAPA Projects

1 Need access for FDA
inspection 
1 Audit Trail

v Complet...
Corrective and Preventive Action (CAPA)

Remember -

1 A formal process is
needed to report on
status of CAPA
project

1 A...
Corrective and Preventive Action (CAPA)

A helpful tool for CAPA
project teams .  . . 

Copyriglit 3013 51
Task List for C APA Plan

| -_ I.  -_ II

‘ Create “will be" Process Flow 
I .  ‘ ‘

Review Current Procedures and 
I .  ....
Questions? ??

Copyright 3013
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CAPA Training Presentation

Corrective and Preventive Actions - a guide for FDA regulations and best practices

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CAPA Training Presentation

  1. 1. Corrective and Preventive Action (CAPA) COI‘v'ii'; 'i_l, .‘ . C&_' : .E u « N ‘ — Compliance Insight 5850 Boymel Dr. , Suite 1 Fairfield, OH 45014 513-860-3512
  2. 2. Corrective and Preventive Action (CAPA) 1 Three Positions - Proactive - Reactive - Interpretive (, ‘0p_ right 3013
  3. 3. Corrective and Preventive Action (CAPA) Corrective and Preventive Action is a primary focus of the FDA during inspections Cop_righl 2013
  4. 4. Some Regulations ISO 9000 Corrective and Preventative Action - Section 4.14 The supplier should document detailed procedures that execute both corrective and preventative actions. This includes detection of non—conforming products. generating corrective and preventative actions, and implementing these actions into the workplace. A corrective action procedure should include. but is not limited to. the following: Customer complaint handling Investigation and documentation of nonconforming products - Appropriate corrective action for nonconformance Establishment of a control system to validate the corrective action Apreventative action should include, but is not limited to, the following: 0 References of information regarding such issues as quality, audits. records & customer complaints Necessary steps to manage problems requiring preventive action Controls to assure that the action is successful Managerial review to appraise preventive action C0p_Tighl 3013 -l
  5. 5. Some Regulations ICH Q7 2.4 Internal Audits (Self Inspection) “Aiidi/ findings and corrective actions should be documented and brought to the attention Q/ 're. s'por1.s'ible management Qfthefirm. Agreed corrective actiorrs should be completed in a timely and effective manner: ' I v The intent is not solely for corrective actions to be implemented/ led by QA v Internal audit is not the only driver of C APA v “Corrective Actions” verbiage built into Q7 Copyright 2013
  6. 6. Sonic Regulations 21 CFR Part 211.192 “A written record oftlre imestigatlion shall be made and shall include the C()I7CllI. S'l0I7.S' and followup. " This is where most people fail - no followup unless there are additional failures due to v the original conclusion being incorrect or ~r the changes created other failures Copyright 3013 6
  7. 7. Corrective and Preventive Action (CAPA) The GMP regulation has sections for - complaints - investigations - deviations They are not intended to simply record problems . . . ( ‘op_ riglit 3013
  8. 8. Corrective and Preventive Action (CAPA) The purpose of these sections is to have problems come to the attention of appropriate 3 personnel (management) in . a way that brings » permanent solutions Copyright 3013 8
  9. 9. Corrective and Preventive Action (CAPA) W‘ Typically, some FDA # enforcement action prompted the focus for a CAPA program Copyright 3013 9
  10. 10. Corrective and Preventive Action (CAPA) Success of CAPA depends upon the planning that goes into it Cop} right 3013 ll)
  11. 11. Corrective and Preventive Action (CAPA) You are Here Questions to ask yourselves - . Where do we really stand? . Do we really know? Cop} right 3013 l I
  12. 12. Corrective and Preventive Action (CAPA) When asked by the FDA if your corrective actions reflect findings by your internal audit program. .. fit answer that you don’t usually concern yourself with that level of detail Cop) right 3013 13
  13. 13. Corrective and Preventive Action (CAPA) lJ DJ Take into account three points when deciding the scope of the plan Cop_‘right 3013 13
  14. 14. Corrective and Preventive Action (CAPA) #1 Conduct a quality system assessment ~ Independent, detailed evaluation of all GMP quality systems - System owners ~ Experts Cop_‘right 3013 14
  15. 15. Corrective and Preventive Action (CAPA) #2 Utilize other corporate sites - Domestic - International ( ‘op_riglil 2013 15
  16. 16. Corrective and Preventive Action (CAPA) #3 Develop a complete plan for the CAPA program - delegate work ~ support company strengths Cop_‘right 3013 16
  17. 17. Corrective and Preventive Action (CAPA) Other places you can find information for CAPA (Internal) v Customer complaints slnvesfigafions v Deviations v Other Sites Cop_Tight 2013 17
  18. 18. Corrective and Preventive Action (CAPA) More places to find CAPA information (External) v 483 v Warning Letter ,3 v Your company and others l‘op_riglil 2013 lb’
  19. 19. Corrective and Preventive Action (CAPA) Four points to / consider when _—I A 5 r , , *4 correcting problems Copyright 2013 19
  20. 20. Corrective and Preventive Action (CAPA) #1. Root Cause Determination or A thorough understanding of the entire situation is essenfial -r Without a root cause determination, you are only " guessing -r Problem will repeat Copyright 3013 20
  21. 21. Corrective and Preventive Action (CAPA) #2 Determine scope of the problem ‘ v This problem may be /1 I‘ indicative of issues ' that go beyond just § the initial difficulty v Could be causing problems throughout several systems Copy right 3013 31
  22. 22. Corrective and Preventive Action (CAPA) #3 Prevent Recurrence v Which system failed? ’ — Thorough systemic ‘ examination will bring issue to light and aid in recurrence prevention Copy right 2013 32
  23. 23. Corrective and Preventive Action (CAPA) #4 Prevent Recurrence at Corporate Level -r Larger corporations can support expertise and technology from vanouslocafions r This applies to knowledge gained from internal quality system audits and regulatory inspections lo '4) Copyright 3013
  24. 24. Corrective and Preventive Action (CAPA) r A corporate system that allows sharing _ consequential jj , information and ‘ provides the opportunity for continuous, global I improvement. 1 Executive management 4;, I must set these peak expectations as a goal Copyright 3013 24
  25. 25. Corrective and Preventive Action (CAPA) . Remember the FDA believes that one site is part of the entire company. r If an observation is noted at two separate locations, it is still considered a repeat observation Copyright 3013 25
  26. 26. Corrective and Preventive Action (CAPA) Q. ‘ Utilize proper strategy . There can be no “one size fits all” approach . There are various points to consider when deciding on tactics I ‘opy right 3013 36
  27. 27. Corrective and Preventive Action (CAPA) Executive Management , Effective CAPA programs require execufive management to take ownership 1 Practical CAPA programs usually do not focus on one department's activity Copyright 3013 37
  28. 28. Corrective and Preventive Action (CAPA) v QA receives progress reports - Standing agenda item — Require target dates — Request milestones Copy right 3013 28
  29. 29. Corrective and Preventive Action (CAPA) v Site Meetings/ T raining Explain CAPA and the regulatory requirements - Define management position - Should be realistic but positive Copy right 3013 29
  30. 30. Corrective and Preventive Action (CAPA) Management delegates someone to drive CAPA resolution . Typically, this is the QA department head . Someone who can facilitate completion . Report directly to the president Copyright 2013 30
  31. 31. Corrective and Preventive Action (CAPA) The driving forces must prevent those doing the work from _ distractions ‘T 1 Those doing the work should not be doing managerial work, trying to make in decisions that could (63 slow down process / Copyright 3013
  32. 32. Corrective and Preventive Action (CAPA) The driving forces should be part of the CAPA project meetings. They can learn status, acquire insight and gain other pertinent information Copy right 3013
  33. 33. Corrective and Preventive Action (CAPA) The Right Strategy Q . You cannot have an effective CAPA process without a strategy . Complicated circumstances often dictate the layout of the strategy Copy right 20 13
  34. 34. Corrective and Preventive Action (CAPA) Common Failures of $(a CAPA implementation 39 ' Lack of. .. F ‘ v Examination . Agreement v Communication v Execution ( ‘opy right 3013
  35. 35. Things to Consider About CAPA r Successful execution of CAPA is highly dependent upon the effectiveness of the planning that goes into it. « The temptation is to “just do it. ” r CAPA is a major focus of FDA during inspections. Keep the list current/ controlled. Copyright 3013
  36. 36. Keep Calm Establish a Plan of Execufion - Training - Validation ~ Logistical Concerns ~ Regulatory Concerns - Documentation List Copyrigltl 3013 36
  37. 37. Effective Preparation Form project teams , Find the right skills «e A and experiences j»', ‘r , , 1 Define roles ‘ ' — each member X — team role ‘ -r Provide training — project management — quality management - problem solving . . Outline priorities Copyright 3013
  38. 38. CAPA Interaction Plan v Written communication plan — SOP or CAPA specific - Identifies all relevant players — Outlines types of communication - Communication frequency (Top) right 3013 38
  39. 39. When Documenting CAPAs Major Responsibilities . that are necessary when documenting a CAPA plan . . . Warning - There are quite a few Copyrigltl 3013 39
  40. 40. In the details CAPA writing . Specific Title . Avoid unnecessary descriptors . Dates/ times/ document names and numbers/ Deviation numbers . Fact and action, Problem to resolution (think case files, CSI, lnvesflgafion) . When in doubt, Ask! Cop} right 3013 ‘D -ill
  41. 41. Defining the CAPA Define CAPA scope . Outline activities that fall inside and outside the scope . Must be defined early in planning stages in order to receive prior approvals Copyright 2013 -ll
  42. 42. Continuous Evaluation . Study problem . Determine extent . Establish root cause . Use a process flow diagram of current system - Where we are now — Gets everyone on the same page Copyright 2013
  43. 43. Updates to Procedures Secure Approvals for New/ Updated Procedures . By this point, there should be no surprises Cop} right 2013
  44. 44. Proof of Execution Assemble Documentation I, SOPs tr Records er Audits . , Training Copyriglil 3013 44
  45. 45. Change Management 0 ‘ 0 Control Process Q 0 . Document Control ' U § « Change Control I ‘op_ riglit 3013
  46. 46. CAPA Meetings Review Preparation «r Review Project Team / ,, Analyze CAPA I Scope er Examine Interaction Plan -r Review Issues Copyriglil 3013 46
  47. 47. Corrective and Preventive Action (CAPA) Conduct Training . Who to train o Who will do training . Training method . Evaluation . Documentation Copyriglil 2013 -I7
  48. 48. Corrective and Preventive Action (CAPA) Perform Internal Review and Approvals 1 CAPA Project Teams 11 Final usually performed by QA Department Head 1 Gets Executive Management “up to speed” Copyriglil 3013 -I8
  49. 49. Corrective and Preventive Action (CAPA) Archive CAPA Projects 1 Need access for FDA inspection 1 Audit Trail v Complete Documentation Cop_-fight 2013 49
  50. 50. Corrective and Preventive Action (CAPA) Remember - 1 A formal process is needed to report on status of CAPA project 1 A formal tracking method must be used to measure progress of teams (‘op_ri«__vlit 3013 50
  51. 51. Corrective and Preventive Action (CAPA) A helpful tool for CAPA project teams . . . Copyriglit 3013 51
  52. 52. Task List for C APA Plan | -_ I. -_ II ‘ Create “will be" Process Flow I . ‘ ‘ Review Current Procedures and I . . . . n Establish New Policies and - Use CAPA Experts to Corroborate Design I K - ' A I - ' I " I~|1, . A ‘III’ ‘ -uh Ii‘: -,-I ; coo. , “A I ' A'A'o- Phase Description: 1 = Preparation, 2 = Design. 3 = Implementation, 4 = Verification C0p_Tight 3013 52
  53. 53. Questions? ?? Copyright 3013

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