corrective action and preventive action procedure start

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


(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


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.


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


Practices


Practices


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


Practices


Practices


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



Practices


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


(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


Practices


Practices


Practice important?

Let’s now take a look at how to complete each section of the CAPA

form GL-GMP-203-1.


(SOP GL-GMP-203)




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


Practices


Practices


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.


(SOP GL-GMP-203)



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?


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.



Senior Management



Well done

1 point!

44

X

Reveal Answer

Senior Management



Well done

1 point!

CAPA Owner

Action Owner


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.



Well done

1 point!

CAPA Owner

Action Owner


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.



Well done

1 point!

CAPA Owner

Action Owner


Senior Management

50

X

Agenda



(SOP GL-GMP-203)


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.


Client expectations

Importance to our organization

Possible consequences

51

X

Agenda


Practices


Practices


Practice important?

The CAPA Procedure is important to our clients.


Client expectations



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


Practices


Practices


Practice important?

The CAPA Procedure is important to our

organization. Client expectations




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


Practices


Practices


Practice important?

Let’s look at an example of a possible consequence in more

detail. Client expectations




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


(SOP GL-GMP-203)


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


Practices


(SOP GL-GMP-203)


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.

corrective action and preventive action procedure start

Documents

capa form

capa benefits

capa process

acronym capa

im capa

sop glgmp

preventive actionaction

quality product