It is all about the following statment : "The ability to simplify means to eliminate the unnecessary so that the necessary may speak." Hans Hofmann

1. Prepared by: Dr/Anthony Gamal
(CMQ/OE certified professional)
For Contact: Antonygamal@yahoo.com

4. Corrective
&
Preventive
actions
Facility &
Design
Equipmen
control
t controls
Quality
Management
System Productio
n&
Material
Process
controls
controls
Records &
document
s Change
control

5. Corrective
&
Preventive
actions
Facility &
Design
Equipmen
control
t controls
CAPA system
Productio
n&
Material
Process
controls
controls
Records &
document
s Change
control

7. Symptoms: Losing balance , Hypertension , paralysis
and finally death.
Overloading system with inputs without
first organizing them will result in :
1-wasting time and effort in so many tasks without considerable
outcomes.
2-Losing directions inside the CAPA maze.
3-Tension between departments and Silo thinking.
4-Paralysis of all activities waiting for the system to restart.
5-CAPA system terminated prematurely and abandoned .

8. Where to start ?
When to start ?
How to start ?
How to organize effort?

11. 1-First collect data about the inputs for the CAPA system.
2-Rate inputs using a risk based prioritization system.
3-Focus on the Vital few and monitor the useful many until being
addressed.
4-Set actions based upon relative weight.
5-Allocate resources based upon the risk based approach.
6-Investigate root cause .
7-Apply corrective actions.
8-Assess the effectiveness of corrective actions.
9-Assess the impact and in case of presence of high impacts set
preventive actions.
10-
10-Assess effectiveness of preventive actions.
11-
11-Track and trend.
12-
12-Set control points.
13-
13-Document all steps at the quality management system.

12. Input
CAPA system
Evaluate
(Issue review) Flow Chart
Yes NO
Correct
(Take action)
Effectiveness Corrective
checks action
High
Preventive
Impact action
Low
Track/Trend
Fail Pass
Implement Changes Document

13. CAPA input Deviation Origin
Document Review Worksheet
assessment Worksheet
OOT Product Non-conformity
OOS External Audit finding
NCR Internal Audit finding
Define origin Incident
Complaint Others:………………………
management review
Report No.:
…………………………………...……………………………………………………………
Collect Data
Data collection
…………………………………………………………………………………………………
What
……………………………………………………………………………………………………
Where ……...……………………………………………………………………………………………
.……………………………………………………………………………………………
……………………………………………………………………………………………………
When ……...……………………………………………………………………………………………
.……………………………………………………………………………………………
……………………………………………………………………………………………………
Who ……...……………………………………………………………………………………………
.……………………………………………………………………………………………
……………………………………………………………………………………………………
Weight ……...……………………………………………………………………………………………
.……………………………………………………………………………………………
Define risk priority Risk assessment Matrix ( Gateway )
1. Put circle around the figure that
Acceptable
Unacceptable
Impact(Severity)Scale
Negligible
describe the corresponding Severity and
Critical
Major
Minor
Occurrence of the problem.
High risk
2. Define the reproducible number for the
two values.
Revised problem statement ١ ٣ ٥ ١٠
The encountered Deviation
٥ ٥ ١٥ ٢٥ ٥٠
Occurrence
risk assessment rating is: Continually
……………………………… Frequently ٣ ٣ ٩ ١٥ ٣٠
Occasionally ٢ ٢ ٦ ١٠ ٢٠
١ ١ ٣ ٥ ١٠
Revised problem statement The encountered deviation is described as
Rare
…………………………………………………………………………………………………………………………………
…………………………………………………………………………………………………………………………………
……………………
Action Recommendations Recommendation
Initiate CAPA request
Add to NCR and start Investigation
Track and trend
archive for knowledge management
Prepared By: ………………………………
approved By: ………………………………

14. 1. Select the figure that Acceptable Impact(Severity)Scale
describe the corresponding
Severity and Occurrence of Unacceptable
the problem.
Negligible
Critical
Minor
Major
High risk
2. Define the reproducible
number for the two values. 1 3 5 10
5 5 15 25 50
Continually
Occurrence
3 3 9 15 30
Frequently
2 2 6 10 20
Occasionally
1 1 3 5 10
Rare

15. Response Adv. Consequences
Trial & Error 1-Instantanious. 1-Reactive.
2-Can reduce damage. 2-May add to variability in
3-Might find solution on problem.
first trial. 3-Very risky.
Expert 1-Expand participation. 1-depend upon educated
/experiential 2-More Proactive. guesswork
3-Depend on rather than facts.
experience 2-Risk of “Group think”.
3-When experienced personnel
leaves so does tacit knowledge.
Comparative 1-Fact-based. 1-Requires facts.
(Investigative) 2-Objective. 2-May take time at first.
. 3-Very proactive 3-People always resist.
4-work efficiently with
experience/Expertise

16. Actions
Levels

17. 1-Arrange actions into categories.
2-Set action categories in order using their due dates.
3-Test actions for effectiveness.
4-follow up proper implementation.
5-Close CAPA.

18. CAPA inputs
CAPA
Filtration
system
Investigation
Root cause
A

19. A
Define Action
Functional departments
Define responsibility
Quality Assurance
Define Due dates
Apply Actions
Effectiveness check
Closing CAPA

20. Dr/Anthony Gamal