corrective action and preventive action procedure start
Post on 03-Jan-2016
246 Views
Preview:
TRANSCRIPT
Corrective Action and Corrective Action and Preventive Action ProcedurePreventive Action Procedure
Start
2
XWelcome
Welcome to the Corrective Action and Preventive Action (CAPA) Procedure eLearning!
This course is designed to outline the principles which must be followed in order to accurately complete the CAPA process.
Please make sure you have read SOP GL-GMP-203 prior to completing this training module.
If you need instructions on navigating the program, please click here.
This module will take approximately 60 minutes.
Click next to start the course
3
XSession Guidelines
There will be a quiz at the end of this course!
To help you prepare for the quiz, you will be able to collect points during the training.
Hi, I’m CAPA!
I will let you know where you can collect the points.
You should aim to collect approximately 40 points in order to be ready to take the quiz at the end.
4
XObjectives
At the end of the program, you will be able to:
Define Corrective and Preventive Action and the Regulatory expectations.
Describe the CAPA Procedure.
Describe the CAPA form and its proper use.
Explain CAPA Procedure roles/responsibilities.
Identify CAPA benefits and impacts to clients and our organization.
5
XGMP Review
• Good Manufacturing Practice (GMP) is concerned with the manufacture and subsequent testing of medicinal products to ensure they are fit for their intended purpose and do not place patients at risk due to inadequate safety, quality or efficacy.
• Quality Control (QC) is the part of GMP concerned with the sampling, specification and testing, documentation and release procedures thus ensuring products are not released for use until deemed of a suitable quality.
• GMP and QC – Assuring patient safety through a quality product, manufactured and tested in a consistent manner.
First, a quick review about GMP…
6
X
Agenda
Introduction to the CAPA Procedure
CAPA Process &Form Review
(SOP GL-GMP-203)
Why is the CAPA Procedure important?
The training is divided into these 3 main
sections.
7
X
Overview
Benefits
Definitions
Agenda
Introduction to Good Documentation
Practices
CAPA Process &Form Review
(SOP GL-GMP-203)
Why is the CAPAProcedure important?
Click on the first section, “Introduction to the CAPA
Procedure” to get started.
Introduction to theCAPA Procedure
All sections are divided into 3 parts.
8
X
Agenda
Introduction to Good Documentation
Practices
Applying Good Documentation
Practices
Why is Good Documentation
Practice important?
For this first section, we’ll start with an overview to clarify what we mean by
CAPA.
Introduction to the CAPA Procedure
Overview
Benefits
Definitions
9
XDefinition of CAPA
Do you know what the acronym CAPA stands for
and what it means?
Yes No
Since there is a test at the end of the course, let’s just remind ourselves of what it is.
Click next to continue
10
XDefinition of CAPA
Corrective Action
Action taken to rectify a detected ‘quality defect’ or
undesirable situation, mitigate its impact and eliminate
the cause, in order to prevent recurrence.
Preventive Action
Action that corrects or eliminates the root cause of a
potential non-conformity, defect or other undesirable
situation and therefore prevents occurrence.
Corrective Action Preventive Action
The CAPA Procedure is found in SOP GL-GMP-203:
11
XPolicies
So, why do you think we have the CAPA Procedure and its associated form?
SOP: GL-GMP-203Form: GL-GMP-203-1
When you see this notepad symbol, take out your notepad and pen so that you can jot down some
notes.
Be sure to write a few notes now before clicking next.
12
XPolicies
We asked a colleague in the Regulatory department to make some notes.
Click on the button below to reveal the notes they made.
Reveal Notepad
Quality
Compliance
Meet Client
expectations
Incorporate industry
standards and best
practices into our
processes
13
XPolicies
Quality
Compliance
Meet Client
expectations
Incorporate industry
standards and best
practices into our
processes
Did you have any of these words on your notepad?
Give yourself 1 point for each word you wrote
down.
Maximum points is 5!
14
X
Agenda
Introduction to Good Documentation
Practices
Applying Good Documentation
Practices
Why is Good Documentation
Practice important?
For the next part of the Introduction, let’s look at some
of the benefits of the CAPA Procedure.
Introduction tothe CAPA Procedure
Overview
Benefits
Definitions
Click next to continue.
15
XBenefits
What do you think are some of the benefits of the CAPA Procedure?
Click next when you’re ready to continue.
16
XBenefits
We asked a colleague to make some notes.
Click on the button below to reveal the notes they made.
Reveal Notepad
Improves quality
Continual Improvement
Prevents Potential Problems
Reduces Recurring Problems
Meets Regulatory Expectations
Tracking of Remedial Actions
Good Client Relationship
17
XBenefits
Did you have any of these words on your notepad?
Give yourself 1 point for each of these words you
wrote down.
Maximum points is 7!
Improves quality
Continual Improvement
Prevents Potential Problems
Reduces Recurring Problems
Meets Regulatory Expectations
Tracking of Remedial Actions
Good Client Relationship
18
X
Put into more detail, here are 3 benefits of following the CAPA Procedure:
1. Provides an effective tool to manage process improvements.
Benefits our Clients.
2. Ensures quality and process excellence by preventing/addressing determined root causes.
Benefits the quality of Processes.
3. Generates credible source documentation to meet the client and regulators' requirements.
Benefits Your and the organization’s reputation with industry and Regulatory Agencies.
Benefits
19
X
Agenda
Introduction to Good Documentation
Practices
Applying Good Documentation
Practices
Why is Good Documentation
Practice important?
Besides Corrective and Preventive Action, there
are a couple more definitions to know for
CAPA.
Introduction tothe CAPA Procedure
Introduction
Benefits
Definitions
Click next to continue.
20
XDefinitions
Quality Defect
Root Cause
We’ll review each of these
separately, but first write your
definition of these terms on
your notepad.
Then, starting with Quality Defect, click each box to check
your answers!
21
X
Collective term used to describe any problem, observation, non-conformance, deviation, undesirable situation or trend that requires corrective or preventive action.
Definition of Quality Defect
Quality Defect
Root Cause
Give yourself 1 point if your definition matches and then click on Root
Cause!
22
X
An identified reason for the presence of a defect or problem, which if eliminated would prevent recurrence.
Definition of Root Cause
Quality Defect
Root Cause
Give yourself 1 point if your definition matches and then click next to
continue!
23
X
Agenda
Introduction to the CAPA Procedure
Applying Good Documentation
Practices
Why is Good Documentation
Practice important?
This second section is all about the CAPA process.
Click on the agenda to the left to continue with the training.
Using the CAPA Procedure
GL-GMP-203-1 CAPA Form Review
CAPA Roles & Responsibilities
CAPA Process &Form Review
(SOP GL-GMP-203)
24
XUsing The CAPA Procedure
Click here for a list of events that might require a CAPA.
We’ll begin with a quick review of when to use the CAPA Procedure.
Write down on your notepad any events that you think might require a CAPA.
26
X
– Inspection Observation Trends.
– Deviations requiring longer term corrective action.
– Out-Of-Specification, Out-Of-Trend, and Atypical Results.
– Customer Complaints.
– Product Recalls.
– Issues or trends raised during Management Review.
– Conclusions from Risk assessment.
Using The CAPA Procedure
You may therefore initiate CAPA to address:
27
X
Key actions to begin the CAPA process:
The CAPA Process GL-GMP-203
CAPA Requestor
Notify Line Management of an identified actual or potential quality
defect that requires corrective OR
preventive action.
Manager
Appoint a CAPA Owner.
CAPA Owner
Initiate a CAPA form and request a
tracking number from GMP QA.
28
XThe CAPA Form GL-GMP-203-1
The accurate determination of root cause(s) is critical to successful CAPA outcomes!
Step #1: Understand what the problem is by investigating and determining root cause(s).
Step #2: Propose actions that will address the root cause(s).
Key steps in completing the CAPA Form include:
29
XDetermining Root Cause(s)
Why?
Why?
Why?
Why?
Why?
To determine Root Cause(s) – ask the question ‘Why?’
at least five times.
Click here to see how this works.
30
X
1. Why?– Because the Memorial is being washed
more frequently.
2. Why?– To remove the increased number of bird
droppings.
3. Why?– Because there’s an increased bird
population.
4. Why?– Because there’s an increased spider
population.
5. Why?– Because there’s an increased insects
population.
6. Why?– Because insects are drawn to the light used
to illuminate the memorials in hours of darkness, specifically at dust and dawn.
A Real Example – Keep Asking ‘Why?’
Problem: The Jefferson Memorial is eroding at a higher rate than usual.
Solution: Turn the lights on one hour later and turn them off one hour sooner.
31
X
Agenda
Introduction to Good Documentation
Practices
Applying Good Documentation
Practices
Why is Good Documentation
Practice important?
Let’s now take a look at how to complete each section of the CAPA
form GL-GMP-203-1.
CAPA Process &Form Review
(SOP GL-GMP-203)
Using the CAPA Procedure
GL-GMP-203-1 CAPA Form Review
CAPA Roles & Responsibilities
32
XSection 1 Form GL-GMP-203-1
Record the outcome of the investigation in
Section 1 of the CAPA form and
attach any supporting
documentation.
Determine and agree upon proposed
actions and target date(s).
CAPA Owners determine which departments/individuals will need to contribute to the investigation and complete the following:
Assign responsibilities for each action to an Action Owner and
provide details.
33
X
The Manager/GMP QA signs and
dates Section 1 of the CAPA to pre-approve the
form.
Always make sure that you are using the most up to date form.
Section 1 Form GL-GMP-203-1CAPA Owners must sign and date the pre-approval portion of Section 1, and get Pre-approval from the Manager and GMP QA. Purpose: to review the proposed corrective or preventive actions to ensure the quality defect is fully addressed and the timelines and responsibilities are appropriate.
34
XSection 1 Form GL-GMP-203-1
Action Owners (or designee) confirm completion of each action in Section 1.
Initial and date each action in Section 1 to confirm completion. Provide evidence of action completion as
required.
35
XSection 2 Post Approval GL-GMP-203-1
On completion of all actions (confirmed in Section 1) the CAPA is post-approved by completion of Section 2.
Completed CAPA forms are stored within GMP QA and archived in accordance with the
site records retention policy.
36
X
Key actions for CAPA implementation:
CAPA Implementation
CAPA Owner
Coordinate the implementation of the CAPA
in accordance with the approved actions.
Keep GMP QA appraised of progress and completion.
Action Owner
Sign and date each action in Section 1 of the CAPA form to
confirm completion.
Record any deviations to the pre-approved actions in the
comments section of the form.
37
X
Always make sure that all the appropriate information is included in
all sections.
And remember: Effective actions eliminate root cause(s)!
Section 1 GL-GMP-203-1
REMINDER #1: Each action will be signed for and closed on a case by case basis on completion of the action, by the:
– Action Owner or Designee
REMINDER #2: Section 2 (Post-approval) is completed after all actions in Section 1 have been closed.
38
X
1. CAPA Owners
2. GMP QA
Monitoring CAPA Progress
That’s right – and they do so on a quarterly basis as well as raise (with the CAPA Owner
and Line Management if necessary) CAPAs that are nearing or have passed their target
completion dates.
Give yourself 2 points if you got this correct!
Do you know who monitors the progress of an open CAPA?
39
X
Agenda
Introduction to Good Documentation
Practices
Applying Good Documentation
Practices
Why is Good Documentation
Practice important?
This next section is an activity that provides you with descriptions of
different responsibilities associated with the CAPA process and you’ll be choosing
which role is being described.
CAPA Process &Form Review
(SOP GL-GMP-203)
Using the CAPA Procedure
GL-GMP-203-1 CAPA Form Review
CAPA Roles & Responsibilities Click next to
continue and good luck!
40
X
Reveal Answer
Senior Management
CAPA Owner
Coordinates the completion of a CAPA. Ensures all Action Owners are aware of their responsibilities and action timelines.
Which role does this apply to?
CAPA Roles & Responsibilities
Action Owner
GMP Quality Assurance
Section Manager / Area Manager / Supervisor
Well done
1 point!
42
X
Reveal Answer
CAPA Owner
Action Owner
Ensures the action assigned to them is completed within agreed timelines.
Which role does this apply to?
CAPA Roles & Responsibilities
Senior Management
GMP Quality Assurance
Section Manager / Area Manager / Supervisor
Well done
1 point!
44
X
Reveal Answer
Senior Management
GMP Quality Assurance
CAPA Roles & Responsibilities
Well done
1 point!
CAPA Owner
Action Owner
Section Manager / Area Manager / Supervisor
Manages the CAPA system, participates in CAPA investigations, pre/post approves CAPAs, acts as CAPA Owner for CAPAs related to Regulatory Inspections & Client Audits and monitors the status of CAPAs. Which role does this apply to?
46
X
Senior Management
Reveal Answer
Appoints a CAPA Owner. Pre/post approves CAPAs within their area of responsibility. Ensures resources are available so that actions can be completed within agreed timelines.
Which role does this apply to?
CAPA Roles & Responsibilities
Well done
1 point!
CAPA Owner
Action Owner
GMP Quality Assurance
Section Manager /Area Manager / Supervisor
48
X
Section Manager /Area Manager / Supervisor
Reveal Answer
Ensures that there is sufficient resource to complete CAPAs initiated within the department. Agrees to any significant capital expenditure proposed as a result of a CAPA.
Which role does this apply to?
CAPA Roles & Responsibilities
Well done
1 point!
CAPA Owner
Action Owner
GMP Quality Assurance
Senior Management
50
X
Agenda
Introduction to the CAPA Procedure
CAPA Process &Form Review
(SOP GL-GMP-203)
Why is Good Documentation
Practice important?
Let’s look at the third and final section of this module.
Click on the agenda to the left to learn why CAPA is so
important.
Why is the CAPAProcedure important?
Client expectations
Importance to our organization
Possible consequences
51
X
Agenda
Introduction to Good Documentation
Practices
Applying Good Documentation
Practices
Why is Good Documentation
Practice important?
The CAPA Procedure is important to our clients.
Why is the CAPA Procedure important?
Client expectations
Importance to our organization
Possible consequences
52
XClient expectations
CAPA is an industry standard (regulatory requirement, etc.)
Clients expect that reoccurring negative events are corrected and/or prevented.
That means identifying root causes and addressing them via CAPA!
Don’t forget…
Anyone can request a CAPA.
53
XImportance to Clients and Regulators
CAPA is important to our clients and the Regulators.
Which of the following do you think they expect?
Click on each answer that you think is correct and then click next to continue.
Quality Product
Process Excellence
Thorough Planning
Timely Follow Through
Eliminate Root Causes
Accurate/Legible Data
54
XImportance to Clients and Regulators
Quality Product
Process Excellence
Thorough Planning
Timely Follow Through
Eliminate Root Causes
Accurate/Legible Data
Give yourself 1 point for each one that you
got correct!
The answer is all of them. Our clients and the Regulators expect:
(This list is not inclusive. Check with your manager about other expectations.)
55
XGlobal Regulatory Requirements
• United States Code of Federal Regulations – 21 CFR 210, 211 & 600
• European Regulations– Rules Governing Medicinal products in the European Union
Volume 4 – Medicinal products for human and veterinary Use: Good Manufacturing Practices
• International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use– ICH Q10 – Pharmaceutical Quality System.
What regulatory authorities do we mean?
Click to review.
57
X
Agenda
Introduction to Good Documentation
Practices
Applying Good Documentation
Practices
Why is Good Documentation
Practice important?
The CAPA Procedure is important to our
organization. Client expectations
Importance to our organization
Possible consequences
Why is the CAPAProcedure important?
58
X
CAPA is important to our clients, regulatory authorities and to our organization.
When CAPA is not followed,write down on your notepad some potential
impacts to our organization.
Importance
Click here to reveal a list of potential impacts.
60
X
CAPA is important to everyone: Our organization, our clients and the Regulatory Authorities.
The Importance Of CAPA
Remember
If appropriate actions aren’t taken,processes can not be improved!
61
XThe Importance of CAPA
As you can see, effective CAPA management has a direct impact on all
aspects of our business.
The CAPA Procedure is essential to ensure integrity, quality and compliance.
62
X
Agenda
Introduction to Good Documentation
Practices
Applying Good Documentation
Practices
Why is Good Documentation
Practice important?
Let’s look at an example of a possible consequence in more
detail. Client expectations
Importance to our organization
Possible consequences
Why is the CAPAProcedure important?
63
XConsequences
Click next to see the outcome when the
CAPA process is applied!
• Each deviation: – consisted of a 5 page deviation form
and 48 page sample inventory.– involved approximately 10 people in
the investigations and impact assessments (metrology, study management, supervisors, managers, trainers).
– required a number of face-to-face meetings.
• Result:– Significant time spent and expense (in
total approximately $12,000).– Loss of business from clients as a
result of some sample integrity issues.
When CAPAs don’t address root causes, examples such as these actual events can happen.
-20°C freezer door was left open on a number of occasions
which resulted in numerous deviations:
64
X
1. Why?– Because the freezer door is being
left open.
2. Why?– The door is opening of it’s own
accord.
3. Why?– Inconsistent locking mechanism.
4. Why?– The freezer door fittings are not
properly aligned.
5. Why?– The freezer unit is not levelled
correctly.
A Real Example – Keep Asking ‘Why?’
Problem: Multiple temperature deviations for a particular freezer
Solution: Level the unit so door fittings correct and fit a door alarm.
65
X
Agenda
Introduction to theCAPA Procedure
CAPA Process &Form Review
(SOP GL-GMP-203)
Why is the CAPAProcedure important?
And Finally…
Here’s a quick recap
And Finally…
We’ve been through all 3 sections of this training.
Click next for a quick review of some of the key
points.
66
XKey Points
CAPA is a regulatory standard, an expected practice, and a GMP organizational Core Value.
Notify management immediately of any issues, problems, questions, or concerns that you have.
It is everyone’s responsibility to ensurethat the CAPA process is followed.
NEVER be afraid to request a CAPA.
ANYONE can request a CAPA.
ALWAYS investigate to determine the true root cause(s) by asking “Why?” at least five times.
67
XAnd Finally
Agenda
Introduction to Good Documentation
Practices
CAPA Process &Form Review
(SOP GL-GMP-203)
Why is the CAPA Procedure important?
To review a section again, click on the item on the agenda to the
left.
Did you get all 40 points?
If you got less than 32 points, you may want to review a
section again before you take the quiz.
68
XQuestions
If you have questions or would like additional information, please contact your Quality Assurance contact.
69
XThank you!
Thank you for taking the time to complete this training.
Please follow your business unit specific process to document your training.
Click on the Exit button (X) at the top right of your screen to exit the course.
The quiz is available as the next item for this session in iLearn.
top related