Investigation tools for Computerized System

Definitions: 

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.

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. 

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 same is captured in audit trail 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 .

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. 

 Root Cause Analysis :-  Problem identification and error solving method. Mostly used tool for RCA are, why why analysis method, and fish bone analysis.

Investigation :- An official examination of the facts about a situation, crime, etc. 

Role of Investigator :- 

1. Trustful and accurate investigation.

2.  Show the fact

3. Identifying the line of inquiry

4. Securing material

5. Recording information

6. Making report

7. Gathering all related evidence

8. Retaining record

Procedure / Investigation Flow:- 

Investigation Tool :- 

1.5 Why Analysis Tool (Why-Why Analysis)

A. What was discovered?

B. Who was Involved?

C. When did the event occurred?

D. Where did the deviation occurred?

E. How was the deviation discovered?

F. How frequent does the process occur?

There is the difference between why and how happened vs what happened.

Origin of Why Method :-  The 5 why's method is the part of the Toyota Production System developed by Sakichi Toyoda, a Japanese inventor and industrialist, the technique become an integral part of the Lean philosophy.

"The basis of Toyota's scientific approach is to ask why five times whenever we find a problem. By repeating why five time, the nature of the problem as well as its solution become clear. " Taiichi ohno

Example :- 

Problem :-  Secondary Packing line machine dropped tablet box on the floor, instead of the conveyor belt. 

Why@1 :- Why does the machine drop the box on the floor.

Ans :-  The first answer you need is why the box does not reach the conveyor. It could be any no. of situations:

• The gripper arm opened too soon
• Gripper arm not in proper position
• The box may be slipping out of arm
• Arm base might be fit on wrong position

Why@2 :- Why the machine arm was not reach the conveyor ?

Ans :- Based on first Question, ans may be

• The gears could be broken
• The arm could be bent
• The base of the machine arm could be rotated out of the correct position
• The scraper seal at the base of the arm rotational is stopping of the arm rotation fully.

Why@3 :-  Why the scraper seal is out of position ?

Ans :-  As per second answer, found arm base is lose and bent due to oil and lubrication problem. So need to be performed timely machine overhauling and preventive maintenance.

Why@ 4:-  Why scrapper seal is not lubricated ?

Ans :-  Servicing and scheduled preventive maintenance not done. Maintenance checklist to be re-looked for seal / oil inspection checkpoint. If needed preventive maintenance frequency shall be revised..

Why@ 5:-  Why need to perform preventive maintenance check related to service of scrapper seal & oil.

Ans :-  Lubrication and oil is required for every movement part. This may be the root cause of the problem that the machine has not serviced enough.

Action Taken 5 Why analysis :- 

• Service and PM is required, Create SOP for service / overhauling of the seal. Club with the existing PM frequency / schedule.
• Adding the problem to FMEA or Control plan to determine if needs more attention.
• Perform training to all concerned persons on "how to perform PM activity in scrapper arm".

2. Fish Bone Method :-

Investigation can be perform five factor.

1. Man:- 

• Education
• Experience
• Work load
• Work handling
• Associate with company

2.  Machine/Equipment :-

• Equipment Qualification
• System Validation
• Break down
• Calibration
• Preventive Maintenance

3. Measurement

• Release testing
• Control Sample testing
• Stability Testing
• Machine Testing
• System Testing

4. Method :-

• Dispensing
• Shifting
• Filling
• Blending 
• Calibration Process
• Data back Restoration process
• SOP
• User management
• Remote working

5. Material :-

• Raw material 
• Finished Goods
• Semi finished Goods
• Packing Material

6. Environment :-

Environment detail such as RH, Temperature, DP, and environment particle monitoring for classified area during process time.