Root Cause Analysis & Corrective and

Preventive Action (PIC/S GMP)

 Root Cause Analysis (RCA) & Corrective and
Preventive Action (CAPA)
(PIC/S GMP)

Prepared By:
Hanna Marie M.Obdianela
Presented By:
Choly R.Villanueva

Quality Assurance Department

Am-Europharma Corporation
March 25, 2025
Reference: PIC/S GMP PE-009-14; ISO 9001:2015_CRR (Cynthia & Romeo Ramirez)
 Objectives
To enable participants to:
1. Identify and apply appropriate
techniques to determine the true root
cause of a nonconformity;
2. Develop and implement effective
corrections, corrective, and preventive
actions to address and eliminate
nonconformities;
3. Assess CAPA effectiveness
through monitoring, verification,
and timely closure of nonconformities.
Outline
Section 1. Introduction
Section 2. Nonconformity and Corrective Action
Section 3. Root Cause Analysis Techniques
Section 4. Why-Why Analysis
Section 5. Cause and Effect Analysis
Section 6. Formulating Corrections, Corrective and Preventive Actions
Section 7. Verifying Corrective and Preventive Action Effectiveness
Introduction
PIC/S GMP:
Chapter I - Pharmaceutical Quality System
An appropriate level of root cause analysis should be applied
during the investigation of deviations, suspected product defects and
other problems. This can be determined using Quality Risk
Management principles.

a) In cases where the true root cause(s) of the issue cannot be determined,
consideration should be given to identifying the most likely root cause(s) and to
addressing those.
b). Where human error is suspected or identified as the cause, this should be
justified having taken care to ensure that process, procedural or system
based errors or problems have not been overlooked, if present.
Introduction
PIC/S GMP:
Chapter I - Pharmaceutical Quality System
An appropriate level of root cause analysis should be applied
during the investigation of deviations, suspected product defects and
other problems. This can be determined using Quality Risk
Management principles.

c). Appropriate corrective actions and/or preventive actions (CAPAs) should be

identified and taken in response to investigations.

d). The effectiveness of such actions should be monitored and assessed.

Nonconformity (NC)

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 NONCONFORMITY (NC)
Definition

• A generic term to indicate the existence of a problem

• Deviation from the norm or standard
• Action is required to revert to conformance

Deficiency, error, lapse, deviation, gap, failure, problem, complaint, product return,
Other Terms violation, breach, mistake, blunder, delay, inaccuracy, inefficiency, ineffectiveness,
oversight, incident, warranty claim, inconsistency, product recall, etc.
NONCONFORMITY (NC)
Definition of Related Terms

o Non-fulfillment of a requirement

• Requirement – need or expectation that is stated, generally implied, or

obligatory

• Defect – a nonconformity related to an intended or specified use; it has legal

connotations, particularly those associated with product and service liability
issues.
NONCONFORMITY (NC)
Potential Sources

1. Nonconforming products or services (e.g. excessive rejection beyond acceptable

rejection rates)

2. Unmet customer requirement (With / without formal complaint)

3. Unfulfilled legal requirement (e.g. Regulatory noncompliance, Contract violation)

4. Incidents (Accidents) (e.g. Due to Human error, poor maintenance, unsafe acts and
conditions)

5. Audit nonconformities (Internal, external audits)

6. Unmet planned results (e.g. Unachieved objectives)

7. Others (e.g. Fraud)

NONCONFORMITY (NC)
Reminder

1. NCs are caused! They don’t happen by themselves (something or someone

caused them).

2. Some causes are preventable; some are not.

3. Preventable causes can be avoided.

4. NCs provide opportunities to improve and strengthen the QMS.

Nonconformity (NC)
Corrective Action
Preventive Action

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When nonconformity occurs:

IMMEDIATE ACTIONS:

React to the nonconformity:

1) Take action to control and correct it;

2) Deal with the consequences
When nonconformity occurs:

CORRECTION
Action to eliminate a detected nonconformity; for product NCs -
includes rework (repair), regrade (to lower grade), or dispose);

-Quick countermeasure or remedial action to stop the NC

situation from continuing
 When nonconformity occurs:

CORRECTIVE ACTION
Action to eliminate the cause(s) of a nonconformity;
takes longer time to plan and implement than correction

Corrective action is done WITHOUT UNDUE DELAY!

When nonconformity occurs:

PREVENTIVE ACTION
A plan of action to be taken to avoid
potential deviations occurring in the
future.

The plan is subject to verifying, follow-up,

monitoring its effectiveness, and report to
management review.
CORRECTIVE and PREVENTIVE ACTION
Benefits (if properly done):

• Reduced cost
• Managed risk
• Improved effectiveness and efficiency
• Enhanced customer satisfaction
• Improved people’s morale

Corrective and Preventive action requires management commitment.

CORRECTIVE and PREVENTIVE ACTION
Process:

1) Review and analyze the nonconformity (NC).

(Investigate. Gather data. Analyze!)

2) Determine the causes of the nonconformity.

(Conduct root cause analysis (RCA) using appropriate technique)

3) Determine if similar nonconformities exist, or could potentially occur.

(Check around. Inspect! Evaluate similar existing NCs, or where they could possibly
occur elsewhere. Validate! Talk to concerned people)

4) Plan and implement needed action.

(Plan the CA based on the RCA found. Then implement them. Plan the PA to avoid
the NC from reoccurring.)
CORRECTIVE and PREVENTIVE ACTION
Process:
5) Review CA and PA effectiveness.
(Check if the CA and PA worked! Evaluate if the root cause recurred, or occurred
elsewhere in the organization)

6) Update risks and opportunities.

(Check and update the risks and opportunities determined during planning)

7) Make changes to the QMS.

(Update the relevant documents, if necessary)

8) Retain documented information.

(Retain records to prove the corrective and preventive action and its impact to address
the nonconformity. This record should show the nature of the NC, the actions taken and
results of corrective action)
CORRECTIVE and PREVENTIVE ACTION
Process:

REMEMBER:

Corrective and preventive actions shall be

appropriate to the effects of the nonconformities
encountered.
CORRECTIVE and PREVENTIVE ACTION
Describing the Nonconformity:

Select the better way to describe a nonconforming situation.

1. The system was ineffective to control changes to maintained documented information; review and
approval of revision to PM-PRO-01 could not be verified.

2. The control system for maintained documented information failed to control changes such as review
and approval of PM-PRO-01 rev.2.

3. The process for controlling maintained documented information was not effective. There was no
evidence of approval of PM-PRO-01 prior to issue to controlled copy holders.

4. The Controller of Documented Information failed to control document changes. e.g. revision of
PMPRO-01
CORRECTIVE ACTION
Describing the Nonconformity:

Select the better way to describe a nonconforming situation.

5. The procedure for controlling maintained documented information was not complied with regard to PM-
PRO-01 revision because of ….

6. The Documented Information Controller lacks Document Change Request for resulting to lack of
review and approval of PM-PRO-01 r2.
NONCONFORMITY REPORT
Three Major Elements:

1) Nonconformity Statement
2) Objective Evidence
3) Requirement
NONCONFORMITY REPORT
Three Major Elements:

1) Nonconformity Statement

• Describes the nonconformity / problem

✓ Concise
✓ Not vague or ambiguous
✓ Focused
NONCONFORMITY REPORT
Three Major Elements:

2) Objective Evidence

• Provides factual basis for the

nonconformity
✓ Relevant
✓ Objective Weigh the evidences objectively!
✓ Verifiable

o Based on available information

o Traceable to source
NONCONFORMITY REPORT
Three Major Elements:

3) Requirement

• Basis for reporting the nonconformity

✓ Appropriate
✓ Accurate
✓ Leads to expected improvement
✓ Basis for evaluating effectiveness of actions taken

Risk: Specifying a wrong requirement leads to wrong action and a

potentially bigger problem ahead.
ROOT CAUSE ANALYSIS (RCA)
 • The application of systematic method to
ROOT identify the cause of a nonconformity
CAUSE
ANALYSIS • The application of systematic method to
identify the cause of a nonconformity
(RCA)
• Result is the basis of planning and
implementing appropriate corrective action
ROOT CAUSE ANALYSIS (RCA)
Wrong Approaches in RCA

1. Root cause is a re-phrasing of the nonconformity

Example:

NC: At the time of audit, three (3) equipment (EQ1, EQ2, EQ3) had not yet been maintained
three months after the schedule.

Root cause: The maintenance schedule for EQ1, EQ2, and EQ3 was not yet carried out.

Note: The NC and the root cause are practically the same
ROOT CAUSE ANALYSIS (RCA)
Wrong Approaches in RCA

2. Root cause is just an excuse about the NC

Example:

NC: At the time of audit, three (3) equipment (EQ1, EQ2, EQ3) had not yet been
maintained three months after the schedule.

Root cause: The mechanic overlooked the maintenance schedule.

• Other excuses are: “forgot”, “busy” and other flimsy reasons.

Note: There is a reason why the mechanic overlooked the maintenance schedule
ROOT CAUSE ANALYSIS (RCA)
Wrong Approaches in RCA

3. Root cause is just a justification why the NC occurred

Example:

NC: At the time of audit, three (3) equipment (EQ1, EQ2, EQ3) had not yet been
maintained three months after the schedule.

Root cause: Because there was lack of maintenance personnel

Note: If manpower is lacking, the maintenance task could have been outsourced
ROOT CAUSE ANALYSIS (RCA)
Wrong RCA: Potential Risks

Wrong cause analysis can lead to:

• Wrong action
• Inefficient use of resources
• Laxity due to false sense of adequate action
• Recurring customer complaint
• Legal violation, including penalties and sanctions
• Uncontrolled risks
• Unmet quality objectives and targets
• QMS breakdown
ROOT CAUSE ANALYSIS (RCA)
Determining NC Root Cause

1) Identify the unfulfilled requirements.

2) Get the facts. Collect relevant data.
3) Validate the correctness of each data.
4) Sort out the data collected to facilitate analysis.
5) Analyze the data. Check for any possible pattern.
6) Apply root cause analysis technique objectively.
ROOT CAUSE ANALYSIS (RCA)
Determining NC Root Cause

DATA
Types of data:
• Qualitative (descriptive)
• Quantitative (numerical)

Sources of data:

A. Internal Sources: e.g. Incident investigation, Process monitoring; Actual observation;

inspection reports; verification and validation data

B. External sources: e.g. News report; Complaints; Product returns; Studies or survey
ROOT CAUSE ANALYSIS (RCA)
Challenges in Getting Data

1. Data needed is not known.

2. Needed data is known but not available or accessible.
3. Available data is not reliable or insufficient for analysis.
4. Data is available but needs tools (e.g. software) to analyze.
5. Lack of cooperation from concerned parties.
6. Intervention by other affected / interested parties.
ROOT CAUSE ANALYSIS (RCA)
RCA Technique: Why-Why analysis

Background

• Developed in 1930s by Sakichi Toyoda of Toyota Motors

• Useful tool for finding root cause by asking “Why” repeatedly
• Also called 5-Why Analysis
ROOT CAUSE ANALYSIS (RCA)
RCA Technique: Why-Why analysis

General Approach

• Define the nonconformity or problem.

• Ask a series of “Whys” (3 to 7, mostly 5 iterations) If you lack “Whys”, you might
not find the correct root cause.
• Create a stair-stepping path from the NC to the root cause.
• Stop when the why-response pair reaches the system or process level.
 ROOT CAUSE ANALYSIS (RCA)
RCA Technique: Why-Why analysis

Example
Background:

Mr. ABC is an executive of a big corporation. He has a company issued SUV being maintained
under the company’s preventive maintenance program. One day, Mr. ABC could not start his
SUV. The mechanic was called in to check. He found out that the battery, which was newly
installed during the most recent preventive maintenance, was discharged. Determine the root
cause of the problem.
Possible statement of the nonconformity:

(1) (focused on the evidence): Mr. ABC’s car did not start. The battery was discharged. OR
(2) (focused on the process): The company’s vehicle preventive maintenance process was not effective.
Evidence: Mr. ABC’s car did not start due to discharged battery
 ROOT CAUSE ANALYSIS (RCA)
RCA Technique: Why-Why analysis

Why-Why Table
Why Focus of Response Basis/
“Why” (Each response should be confirmed before proceeding to next “Why”) Validation
1 NC itself The alternator did not operate to charge the battery. (If it did, the battery Testing
should have been charged while the SUV was running.) (Response 1)
2 Response Alternator belt was broken. (Response 2) Inspection
1
3 Response Alternator belt was not replaced as scheduled on the last scheduled Vehicle
2 preventive maintenance. (Response 3) history
card
4 Response The mechanic overlooked the scheduled replacement of the Interview
3 alternator belt. (Response 4)
5 Response There are no maintenance checklists to guide specific vehicle Procedure
4 preventive maintenance activities. Root Cause
 ROOT CAUSE ANALYSIS (RCA)
RCA Technique: Why-Why analysis

Checking the Logic

NC SUV did not start (Battery was dead)

Why 1
Alternator did not charge the battery

Why 2
Alternator belt was broken
Why 3
Alternator belt was not replaced as
scheduled
Why 4
Mechanic overlooked the scheduled
belt replacement

Why 5
No checklist to guide preventive
maintenance implementation
Root cause
ROOT CAUSE ANALYSIS (RCA)
RCA Technique: Why-Why analysis

Reminder:

Ask: “Why did the process fail?”; not “Why did the person fail?”
 ROOT CAUSE ANALYSIS (RCA)
RCA Technique: Why-Why analysis
Summary:
Background:

Mr. ABC is an executive of a big corporation. He has a company issued SUV being maintained
under the company’s preventive maintenance program. One day, Mr. ABC could not start his
SUV. The mechanic was called in to check. He found out that the battery, which was newly
installed during the most recent preventive maintenance, was discharged. Determine the root
cause of the problem.
Problem: The car did not start. WHY? The battery was dead.
Method of analysis: Why-why technique
Root cause identified: Lack of maintenance checklists resulted to ineffective vehicle maintenance

Lesson:
A small missed item can cause a big problem
ROOT CAUSE ANALYSIS (RCA)
RCA Technique: Cause and Effect Diagram analysis

Background

• Attributed to Kaoru Ishikawa (1982); thus, also

called aptly as Ishikawa Diagram or Fish Bone
Diagram
• A technique that deals with one effect at a time
• Involves the analysis of a process and the
selected factors or categories
• May be used to analyze both for a positive
effect (e.g. an objective or goal) or a negative
effect (a problem or nonconformity)
• Better to use as a team-approach
ROOT CAUSE ANALYSIS (RCA)
RCA Technique: Cause and Effect Diagram analysis

Steps:
1. Build the fish bone diagram
2. Categorize the major bones (main factors) that influence the effect (problem or
nonconformity being analyzed).

MOTHER NATURE MACHINE MAN

NC or

6M Process
problem
statement

METHODS MATERIALS MEASUREMENT

ROOT CAUSE ANALYSIS (RCA)
RCA Technique: Cause and Effect Diagram analysis

Steps:
3. Expand the big bones (major causes) by identifying smaller bones (sub causes)

MOTHER NATURE MACHINE MAN Why

Why Why

NC or
problem
statement
Why Why
Why

METHODS MATERIALS
MEASUREMENT
 ROOT CAUSE ANALYSIS (RCA)
RCA Technique: Cause and Effect Diagram analysis

Steps:
4. Build and expand the fishbone diagram by getting more data and providing more
factors or smaller bones.

ENVIRONMENT MACHINE MAN

Why
Why Why

Use why-why NC or
problem
or other Why Why statement
Why
techniques!
METHODS MATERIALS
MEASUREMENT
ROOT CAUSE ANALYSIS (RCA)
RCA Technique: Cause and Effect Diagram analysis

Steps:
5. Identify and encircle the outermost small bones or significant factors as
basis for selecting the most likely cause(s).

MOTHER NATURE MACHINE MAN

Why
Why Why

NC or
problem
Why statement
Why
Why

METHODS MATERIALS
MEASUREMENT
ROOT CAUSE ANALYSIS (RCA)
RCA Technique: Cause and Effect Diagram analysis

Application:

Building up / enlarging the Fishbone Diagram:

1. Using Why-why technique

2. Using brainstorming technique.
✓ Designate a facilitator and a recorder.
✓ Ask each person to contribute one possible cause at a time.
✓ A person may piggyback on the idea of another person.
✓ Allow a “pass” if a person has no idea to contribute to any cause category.
✓ Repeat the process until everyone says “pass“.
3. Arrange the responses in the fishbone Diagram
 ROOT CAUSE ANALYSIS (RCA)
RCA Technique: Cause and Effect Diagram analysis

Determining the most likely cause:

1. Review the completed fishbone diagram.

2. List down the encircled causes from outermost bones.
3. Validate and choose the most likely cause by:
✓ Logical proof
✓ Reality check
✓ Result verification
4. Decide what’s the most logical root cause of the problem.

Tips:
1) A factor caused by another factor is not considered as a root cause
2) A factor that pops up in several factors could be a root cause
 ROOT CAUSE ANALYSIS (RCA)
RCA Technique: Cause and Effect Diagram analysis

Determining the most likely cause:

Encircled Validation Effect of Conclusion

Causes (check the veracity of short-listed another? (MLC?)
(Example of Causes) Y/N Y/N
shortlisted)
MAN Validated through actual interview and Y N
(Why 2) records reviewed
MATERIAL Validated based on material inventories Y N
(Why 2) and QA inspection.
METHOD Validated based on Process Engineering N Y
(Why 2) procedures and standard parameters

Notes:
1) If the short-listed factor is an effect of another factor, then it is not a root cause.
2) The root cause may “pop” up in several categories of the fishbone.
 ROOT CAUSE ANALYSIS (RCA)
RCA Technique: Cause and Effect Diagram analysis

Example
Background:

Mr. ABC is an executive of a big corporation. He has a company issued SUV being maintained
under the company’s preventive maintenance program. One day, Mr. ABC could not start his
SUV. The mechanic was called in to check. He found out that the battery, which was newly
installed during the most recent preventive maintenance, was discharged. Determine the root
cause of the problem.

NC / Problem statement

The preventive maintenance process was not effective. Mr.ABC’s car did not start due to discharged
battery.
 ROOT CAUSE ANALYSIS (RCA)
RCA Technique: Cause and Effect Diagram analysis

MACHINE MAN
MOTHER X
NATURE X

Mr. ABC’s
car did not
start
X

MATERIALS
METHODS MEASUREMENT
Formulating Correction,
Corrective Action
and Preventive Action

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CORRECTION
Planning the Correction

1. Evaluate the nonconformity and the evidence(s).

2. Check any consequences created by the nonconformity.
3. Determine the actions needed to address the nonconformity and its
consequences, if any.
4. Assign a personnel, provide resources, and establish timeframes
for the implementation of needed actions.
5. Implement the planned corrections – including those that deal with
the consequence of the nonconformity - without undue delay.
6. Monitor progress and timely completion.
 CORRECTION
Planning the Correction

Nonconformity Statement:

The company’s preventive maintenance process was not effective. Mr. ABC’s car did not
start up one day as the battery was empty or discharge.

Correction Responsible When Resources

1. Replace the alternator belt Mechanic, Within 24 Alternator belt
Supervisor hours of battery charger
2. Recharge the battery detection

3. Restart the SUV to confirm battery is working

4. Return SUV to Mr. ABC

CORRECTIVE ACTION
Planning the Corrective Action

1. Evaluate the root cause(s) identified.

2. Check if there are similar existing or potential nonconformities
elsewhere in the QMS.
3. Determine the actions needed to address the root cause(s) of NC and
prevent the potential occurrence elsewhere.
4. Assign a personnel, provide resources, and establish timeframes
for the implementation of needed actions.
5. Implement the planned corrective action without delay.
6. Monitor progress and timely completion.
 CORRECTIVE ACTION
Planning the Corrective Action

Nonconformity Statement:

The company’s preventive maintenance process was not effective. Mr. ABC’s car did not
start up one day as the battery was empty or discharge.

Corrective Action Responsible When Resources

1. Develop PM checklist for all vehicles, incl. Mechanic, September Personnel
forklifts. Supervisor 2025 Specified
2. Revise procedure to reflect the checklists.

3. Implement the checklist. Monitor compliance.

PREVENTIVE ACTION
Planning the Preventive Action

1. Determine the actions needed to prevent the potential occurrence of

the NC in the future.
2. Ensure that the actions are verifiable.
3. Assign a personnel, provide resources, and establish timeframes for
the implementation of needed actions.
4. Implement the planned corrective action without delay.
5. Monitor progress and timely completion.
 PREVENTIVE ACTION
Planning the Preventive Action

Nonconformity Statement:

The company’s preventive maintenance process was not effective. Mr. ABC’s car did not
start up one day as the battery was empty or discharge.

Preventive Action Responsible When Resources

Set a regular audit to ensure that the Audit Team, 2025 Personnel
maintenance checks are being carried out as Management Specified
planned and the established checklist is being
followed.
Verifying Correction,
Corrective Action
and Preventive Action

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VERIFICATION
Implementation of Planned Actions

Responsible:
• Head of Office / Concerned management
• Process owner and / or Designated personnel

Timing:
• Without undue delay (as proposed)

Where:
• Where NC was detected
• Elsewhere in the QMS
VERIFICATION
Prerequisite

• Planned or specified actions are already implemented

• Sufficient time had lapsed
VERIFICATION
Activities

1. Confirm with process owner the completion of their planned corrections

and corrective actions.
2. Ensure sufficient time had lapsed (1-3 months) for the effects of the CA
to be felt or observed.
3. Verify on-site (or by other means) that planned corrections and
corrective actions were indeed implemented.
4. Verify that the problem and its root cause has not recurred, or occurred
elsewhere in the QMS.
VERIFICATION
Techniques

Apply the appropriate method(s):

1. Conduct audit
2. Conduct on-site reality check.
3. Verify actual results.
4. Apply logical proof.
CLOSING THE NC
Activities

1. Follows after verification of CA and PA effectiveness.

2. Verify also the following, as necessary:
✓ Revision of affected documents
✓ Review and updating of risk registries
✓ Communication of changes and provision of training
SUMMARY……
Why RCA and CAPA Matter for Suppliers
• Regulatory Requirement: Compliance with PIC/s GMP, FDA, and
other regulatory agencies
• Quality Assurance/Quality Control: Ensures raw materials and
services meet pharmaceutical standards
• Risk Mitigation: Prevents production delays, recalls, and regulatory
penalties
• Continuous Improvement: Strengthens supplier credibility and trust
with clients
Why RCA and CAPA Matter for Clients from Suppliers

• Ensuring Compliance with PIC/S GMP & Regulatory Requirements Regulatory

agencies such as the FDA, PIC/S, and WHO require pharmaceutical companies to
have strict quality controls.
➢ Regulatory agencies such as the FDA, PIC/S, and WHO require pharmaceutical
companies to have strict quality controls.
➢ If suppliers fail to comply, clients may face regulatory audits, warnings, or even
product recalls.
• Preventing Batch Rejections & Production Delays
➢ If a raw material fails quality specifications, the client must reject the batch, causing
delays and financial losses.
Example: A supplier provides an excipient with microbial contamination → the entire
batch is rejected → production stops → lost revenue.
➢ CAPA ensures corrective measures prevent future supply chain disruptions.
Why RCA and CAPA Matter for Clients from Suppliers
• Protecting Product Quality & Patient Safety
➢ Any defective raw material or service failure can lead to safety risks for the end-
user.
Example: A third-party calibration service fails to calibrate equipment correctly →
inaccurate measurements → product potency deviations → potential harm to patients.

➢ RCA helps trace the root cause of failures and CAPA ensures preventive measures
are in place.
• Strengthening Supplier-Client Relationships
➢ A supplier with an effective RCA & CAPA system gains client trust by
demonstrating proactive quality management.
➢ Clients prefer suppliers who can quickly identify, correct, and prevent issues,
ensuring a smooth supply chain.
➢ Transparency in CAPA processes strengthens long-term partnerships.
Why RCA and CAPA Matter for Clients from Suppliers
• Reducing Costs & Business Risks for Clients
➢ Suppliers that do not address recurring issues cause financial and operational risks
for clients.
Example: A packaging material supplier repeatedly delivers cartons with improper labeling →
clients must rework or scrap packaging → increased costs.

➢ A strong CAPA system minimizes rework, complaints, and costly investigations.

• Aligning with Continuous Improvement & Risk-Based Thinking

➢ Clients expect suppliers to implement continuous improvement and risk-based

approaches as per GMP, ISO 9001, and/or ICH Q9 (Quality Risk Management).
➢ RCA & CAPA allow suppliers to move from reactive problem-solving to a proactive
risk management approach.
Conclusion
In conclusion..

1. Improvement, especially corrective action, requires commitment from

all concerned.
2. Root cause analysis is the pillar of an effective corrective action process.
Equip the people!

3. Improvement is change. A problem cannot be solved by the same mindset

as they were created.

4. Documentation is crucial in proving and sustaining the improvement.

Key Insight:

“A supplier’s ability to conduct effective RCA &

CAPA is not just a compliance requirement but a
critical business necessity. It ensures that
materials and services meet pharmaceutical quality
standards, preventing failures before they reach
production—ultimately safeguarding product
integrity and patient safety.”
Key Insight:

“By implementing effective RCA and CAPA,

organizations move from a reactive to a
proactive approach—reducing risks, improving
efficiency, and maintaining compliance. ”
 Thank you.
www.ameuropharma.com

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