Prepared by: Dr/Anthony Gamal(CMQ/OE certified professional)

For Contact: Antonygamal@yahoo.com

Facility &Equipment controls

Corrective&

Preventiveactions

Designcontrol

Production &

Processcontrols

Records &documents Changecontrol

Materialcontrols

QualityManagement

System

Facility &Equipment controls

Corrective&

Preventiveactions

Designcontrol

Production &

Processcontrols

Records &documents Changecontrol

Materialcontrols

CAPA system

Overloading system with inputs withoutfirst organizing them will result in :

1-wasting time and effort in so many tasks without considerableoutcomes.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 .

Symptoms: Losing balance , Hypertension , paralysisSymptoms: Losing balance , Hypertension , paralysisand finally death.and finally death.

Where to start ?Where to start ?

When to start ?When to start ?

How to start ?How to start ?

How to organize effort?How to organize effort?

11--First collect data about the inputs for the CAPA system.First collect data about the inputs for the CAPA system.22--Rate inputs using a risk based prioritization system.Rate inputs using a risk based prioritization system.33--Focus on the Vital few and monitor the useful many until beingFocus on the Vital few and monitor the useful many until beingaddressed.addressed.44--Set actions based upon relative weight.Set actions based upon relative weight.55--Allocate resources based upon the risk based approach.Allocate resources based upon the risk based approach.66--Investigate root cause .Investigate root cause .77--Apply corrective actions.Apply corrective actions.88--Assess the effectiveness of corrective actions.Assess the effectiveness of corrective actions.99--Assess the impact and in case of presence of high impacts setAssess the impact and in case of presence of high impacts setpreventive actions.preventive actions.1010--Assess effectiveness of preventive actions.Assess effectiveness of preventive actions.1111--Track and trend.Track and trend.1212--Set control points.Set control points.1313--Document all steps at the quality management system.Document all steps at the quality management system.

Input

Evaluate(Issue review)

Effectivenesschecks

Correctiveaction

Correct(Take action)

Track/Trend

DocumentImplement Changes

Impact

NOYes

Low

High

PassFail

CAPA systemCAPA systemFlow ChartFlow Chart

Preventiveaction

Document Review WorksheetDeviation Origin

OOT Product Non-conformityOOS External Audit finding

NCR Internal Audit finding

Incident management reviewComplaint Others:………………………

Report No.:…………………………………...……………………………………………………………

Data collection

What…………………………………………………………………………………………………

Where……………………………………………………………………………………………………

……………………………………………………………………………………………...…… …………………………………………………………………………………………….

When……………………………………………………………………………………………………

……………………………………………………………………………………………...…… …………………………………………………………………………………………….

Who……………………………………………………………………………………………………

……………………………………………………………………………………………...…… …………………………………………………………………………………………….

Weight……………………………………………………………………………………………………

……………………………………………………………………………………………...…… …………………………………………………………………………………………….

Risk assessment Matrix ( Gateway ) Acceptable Impact(Severity)Scale1. Put circle around the figure thatdescribe the corresponding Severity andOccurrence of the problem.2. Define the reproducible number for thetwo values.

Unacceptable

Neg

ligib

le

Min

or

Maj

or

Crit

ical

High risk

Revised problem statement ١ ٣ ٥ ١٠

The encountered Deviationrisk assessment rating is:

Occ

urre

nce Continually

٥ ٥ ١٥ ٢٥ ٥٠

……………………………… Frequently ٣ ٣ ٩ ١٥ ٣٠Occasionally ٢ ٢ ٦ ١٠ ٢٠

Rare١ ١ ٣ ٥ ١٠

The encountered deviation is described as…………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

RecommendationInitiate CAPA requestAdd to NCR and start InvestigationTrack and trendarchive for knowledge management

Prepared By: ………………………………approved By: ………………………………

Define originDefine origin

Collect DataCollect Data

Define risk priorityDefine risk priority

Revised problem statementRevised problem statement

Action RecommendationsAction Recommendations

CAPA inputCAPA inputassessment Worksheetassessment Worksheet

AcceptableAcceptable Impact(Severity)ScaleImpact(Severity)Scale

UnacceptableUnacceptable

Neg

ligib

leN

eglig

ible

Min

orM

inor

Maj

orM

ajor

Crit

ical

Crit

ical

High riskHigh risk

11 33 55 1010

Occ

urre

nce

Occ

urre

nce ContinuallyContinually

55 55 1515 2525 5050

FrequentlyFrequently33 33 99 1515 3030

OccasionallyOccasionally22 22 66 1010 2020

RareRare11 11 33 55 1010

1. Select the figure thatdescribe the correspondingSeverity and Occurrence ofthe problem.

2. Define the reproduciblenumber for the two values.

ConsequencesAdv.Response

1-Reactive.2-May add to variability inproblem.3-Very risky.

1-Instantanious.2-Can reduce damage.3-Might find solution onfirst trial.

Trial & Error

1-depend upon educatedguessworkrather than facts.2-Risk of “Group think”.3-When experienced personnelleaves so does tacit knowledge.

1-Expand participation.2-More Proactive.3-Depend onexperience

Expert/experiential

1-Requires facts.2-May take time at first.3-People always resist.

1-Fact-based.2-Objective.3-Very proactive4-work efficiently withexperience/Expertise

Comparative(Investigative).

ActionsActionsLevelsLevels

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.

CAPA inputs

CAPAFiltrationsystem

Investigation

Root cause

A

Apply Actions

Define responsibility

A

Effectiveness check

Define Action

Closing CAPA

Define Due dates

Qua

lity

Assu

ranc

e

Func

tiona

l dep

artm

ents

Dr/Anthony Gamal