Occurrence Management

Ms. Coosje Tuijn

Ms. Zaruhi Davtyan
Dr. Arsen Zakaryan

Online, ISTC, Central Asia, South-East

May 2022 and Eastern European countries
Session objectives
• At the end of the session, participants will:
– Will be provided with details on corrective actions
– Will see what is the CA process
– Will get the list of the tasks to perform for CA correct
management
– Will be provided with simple tool for situation analysis
– Will understand the links between CA and management
review
Definitions
•  Nonconformity (NC) nonfulfillment of a requirement
– Other terms frequently used include: accident, adverse event, error, event,
incident, and occurrence.
• Corrective action and preventive action (CAPA, also called
corrective action / preventive action) are improvements to an
organization's processes taken to eliminate causes of non-
conformities or other undesirable situations.
• CAPA is a concept within good manufacturing practice
(GMP) and is part of quality management systems
• It focuses on the systematic investigation of the root causes of
non-conformities in an attempt to prevent their recurrence (for
corrective action) or to prevent occurrence (for preventive
action).
Where are NCs and CAPA coming from?
• Corrective actions usually come from the following:
1. IQC
2. EQA
3. Quality indicators
4. Complaints
5. Auto-evaluation
6. Internal audit
7. External audit
8. Method validation/verification
9. Staff suggestions
10. Accidents/incidents
11. “Near-miss”
12. Etc.
Why corrective actions?
• Permanent process improvement
• Identification and elimination of the causes of a
problem, thus preventing their recurrence
– 5 times “why?”
• Saving time, money, energy
• Gaining confidence from the “clients”
• And… getting ISO15189/ISO17025 accreditation
General process for CA
A- Detection B- Remedial
and Report Action

C- Analysis and D- Action plan

Documentation und Follow-up

E- Further F-
analysis and Management
Evaluation review and
Continual
improvement
A- Documenting NC
• Each of the NC origin (IQC, EQA, QI, etc.)
needs to be linked to the future CA
– Attribution of a number to the CA
• Recommended: YYMMDD-XXX-##
• XXX= origin abbreviation
• ##= number
– Paper version: copy of the origin added
– Electronic management: automated process
• Then the CA itself needs to be documented
A- Documenting the CA (*=mandatory)
• Information to collect:
– Type: corrective/remedial *
– Problem date and time *
– Identification of samples/customers/patients involved
– Creation date and time *
– Name of originator
– Title *
– Origin type (IQC, QI, etc.) *
– CA status (generated, being solved, solved, finalized) *
– Laboratory unit/ward
– Problem summary *
– Responsible person allocated to problem solving
– Action plan *
– Resources provided to responsible person
– Conclusion
– Finalization date and time *
– Validation date and time
B- remedial/corrective action itself
• Rapid
• Precise
• Adapted
• Appropriate
• Verified (if possible)
• Documented (always)
Simple rule for situation documentation,
problem analysis and plan of action
preparation
• 5W2H:
– Who
– Where
– What
– When
– Why
– How
– How much
• Can help you streamline the process
C- Analysis and documentation
• What has exactly happened?
• Which (possible) consequences did the incident/occurrence
have?
• Which possible staff behavior can be postulated?
• How was the incident identified?
• How did the incident happen in detail?
• Why could the incident happen: System? Competence?
Behavior? (Cause analysis)
• Who has documented the initial report? Who is involved?
• Documentation of all relevant data (within 48 hours), immediate
analysis if possible
C- Analysis and documentation
• Process mapping and flowcharting
• Cause and effect-diagram ( for example Ishikawa “fish bone”
diagram)
• Consideration of: Man, Machine, Method, Material, Milieu
Including the consideration of possible active and latent
nonconformities
 Root cause analysis example: 5 X why
WHY? WHY? WHY?
Specific presentation available in
LQMS training (English/Russian)

WHY? WHY?
D- Action plan and follow-up
• Following the root cause analysis the corrective
actions are determined including the responsibilities
for the implementation of the actions
• Initial evaluation regarding possible preventive actions
• Follow-up for the verification of the effectiveness of
corrective actions and preventive actions, respectively
• Presentation to Q-manager for data analysis and
preparation of the next management review
Corrective and remedial action
• A corrective action needs to be performed within a
certain (short) amount of time
– No real emergency
– But must be achieved rapidly
• A remedial action needs to be performed immediately
– Out of control IQC
– Major complain
– Major accident
– Etc.
E- Further analysis and evaluation
• Classification
• Trend analysis
• Long-term evaluation of effectiveness of the corrective
and preventive actions
• Statistics
• Evaluation/review of internal audits
F- Management review and continuous
improvement
• Data presentation and trend analysis
• Modifications of the management system for continual
improvement of the management program for handling
of nonconformities
• Commitment to plans for reduction of nonconformities
• Communication
Management review
 Input  Output
• Legal requirements • Conformity with (new) requirements
• Normative requirements • Update of Q-policy and Q- objectives
• Customer requirements • New Q-plans
• Customer feedback • Preventive actions
• Internal audits • Customer surveys
• Quality objectives • Modified planning of resources
• Complaints • New project suggestions
• Nonconformities/Appeals • Update budget
• Risk analyses • …
• Recommendations for
improvement
• Projects
• (economical) budget
• …
Supporting documents
• CA forms
• PA forms
• Analysis and documentation forms
• Action plan forms
• Analysis/management review preparation forms

• Examples on the next slides (in the DVD)

Example from Lab15189 compliance software
CAP form, USA
Department of
general services,
Virginia, USA
WHO/NHLS
EQA
programme
remedial form
Pasteur Institute
Cambodia (French)
And also
• Usually CA is performed to avoid the recurrence of the
same problem
• But:
– It can sometimes happen again… (i.e. remedial plan was not
appropriate)
– A similar problem can happen again
– A similar problem can happen in another unit/ward
• Which explains the importance of correct and deep
management review
• Monitoring for effectiveness of CA
• And communication between units
• And dynamic/proactive QA manager
Quality indicator out of CA?
• Possible Quality Indicators to develop:
– Number of CA generated weekly/monthly
• All together
• By units
• By origin (EQA, IQC, etc.)
– Turn around time generated/finalized
• All together
• By units
• By origin (EQA, IQC, etc.)
– Other?
Preventive actions (PA)
• Much more tricky than CA
• You need to imagine and prevent the problem before it
happens
• Crystal ball???
Examples
• Problem occurring in one unit
– Could happen to another unit  PA
– Meaning very good communication between units
– Meaning very dynamic quality manager
• Problem occurring in another human or vet lab
– Could happen in another lab  PA
– Meaning well functioning lab network/communication
processes
But also PA at management level
• Highlight needs for:
– New analysis
– New procedures
– Process update
– Policy update
– New risk management system following new analysis
introduction
– New training
– New control process
– Etc.
Summary CAPA

Action Problem Approach Outcome

Remedial Existent Reactive, Alleviates
immediate Symptoms

Corrective Existent Reactive, Prevents

rapid Recurrence

Preventive Nonexistent Proactive Prevents

Occurrence
Objectives of the presentation
• At the end of the presentation, participants:
– Will be provided with details on corrective actions
– Will see what is the CA process
– Will get the list of the tasks to perform for CA correct
management
– Will be provided with simple tool for situation analysis
– Will understand the links between CA and management
review
 Thank you for your attention!

Questions? Remarks? Discussions?

Contacts:
tuijn@iqls.net
davtian@iqls.net
zakaryan@iqls.net