System :- A group / part of things that work together, in other words "A set of ideas or rules or component for organizing the things in a particular way that called system.
Computerized System :- Computer system is a set of integrated device such as processor, motherboard, mouse keyboard, printer, hard disk etc. with the set of logical and physical software instruction which is provided the desired output, its called computerized system.
Deviation / Incident :- Some of organization calling the incident, some of organization is calling this as deviation.
In simple terms Departure from the approved procedure / acceptance limit i.e. departure from procedure written in SOP, departure from instruction written on batch production record, results received and not meeting the acceptance criteria, activity performed which is not the part of any SOP / STP, that is called deviation.
Examples of common deviation :-
1. Procedure stated that, record the readings every hour +/- 10 min. but readings recorded after buffer time (+/- 10 min.) it is a deviation.
2. Someone performed the activity on X day but his/her attendance is not available in system.
Examples of deviation in computerized systems :-
1. In automation system, production process is going on. suddenly SCADA System has malfunctioned. batch production has been stopped / gone in hold state for some time.
2. Batch gone in hold state due to mal-function of instruments / valves / controller / logic issues
3. Periodic backup not taken as per approved schedule.
4. Restoration activity not performed as per approved schedule.
5. Procedure for user creation / modification / deactivation not followed.
6. Unauthorized instances/events logged in audit trail.
7. Major / Critical error observed in windows / application software level.
8. Minor / Critical process alarms not reviewed and proper CAPA not taken.
9. Not able to perform the restoration activity due to corruption of backup.
10. After successful restoration of the backup, not able to generate the reports due to any technical reasons or data corruption.
Types of Deviation :- There are two type of deviation
1. Planned Deviation
2. Unplanned Deviation
Planned Deviation :- Planned deviation is pre-approved procedure before execution is called planned deviation. A planned deviation is temporary changes followed with temporary change control.
Example :- Data back up and restoration is not carried out as per approved schedule due to continuous batch production is going on or it is been delayed due to some other technical reasons.
Unplanned Deviation :- Incident occurred due to unforeseen reasons and uncontrolled event in the form of non compliance and departure from the pre-approved procedure / process / approved plan or pre-approved design. It can happen due to following reasons but not limited to:
- Human error
- Equipment failure
- Malfunction Server / software, Instrument and computer system
- Virus / Malware / Ransomware impacted the computerized system
- Utility or other service failure
Example :- Respective team missed to perform Data back and restoration activity within the time line mentioned in approved schedule.
Classification of Deviation :-
1. Critical
2. Major
3. Minor
Critical :- Approved procedure are not followed, Impact on the product quality Wrong Tag ID Stick in Server, back up activity not performed, report not generated as per design.
Major Deviation :- Moderate to considerable impact to to product quality is considered Major Deviation. i.e Break down during process, Computerized system malfunction during process.
Minor Deviation :- Unlikely to have Detectable impact on product quality is considered miner deviation .
Root Cause Analysis :- Problem identification and error solving method. Mostly used tool for RCA are, why why analysis method, and fish bone analysis.
CAPA :- Divided into CAPA word first is CA :- Corrective Action, Second is PA :- Preventive Action
Corrective Action (CA) :- Action taken to eliminate the causes of non-conformity or other undesirable situations, so as to prevent the recurrence.
Preventive Action (PA) :- Action taken to prevent the occurrence of such non-conformity, generally as a result of a risk analysis and extension of the action / implementation to other facilities line or other similar products.
Change Control Management :- Change control management is the procedure to impact evaluation related to implementation, implementation area, impacted ares, actions identification related to the change.
Change control is must for implementation of any proposed change in pharmaceutical industry arrived from process requirement / investigation / risk assessment.
Procedure / flow for Deviation followed with CAPA implementation :-
1. Problem statement (Must contain minimum these things what happened, when happened, how it happened, who observed)
2. Intimate to immediate Supervisor.
3. Take a immediate action / correction to fix the immediate cause.
4. Inform to QA and file the deviation.
5. Write the immediate correction in deviation along with the problem statement.
6. Get it approved from respective QA authority.
7. QA and user department will be proceed the risk assessment and mitigate the risk. and decide the classification of deviation.
8. QA, user department and CFT person has to investigate the deviation with investigation process using suitable investigation tool i.e why-why analysis / fish bone method and find out the root cause.
9.User Department with consultation with CFT and QA has to prepare the investigation report with all supporting data / evidences supported to the cause. All possible probable / exact causes should be available on the report and should be properly ruled out / defined with the evidence of the data.
9. After find out the root cause QA, user department and CFT has to decide the suitable CAPA against root cause and CAPA implementation plant with target completion date.
10. Change control shall be initiated for the implementation of the CAPA and same shall ne approved by respective stake holder.
11. After implementation of CAPA, CAPA effectiveness shall be observed.
12. If CAPA is not able to implement on time then extension with proper justification shall be initiated and approved by QA.
13. After successful implementation and effectiveness report / completion of CAPA, Respective tasks can be closed.
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