RISK ASSESSMENT STUDY REPORT

 

 

 

Report For RISK ASSESSMENT STUDY

 

 

Document No.	RPT/RAS/01/00
Effective Date
No. Of Pages	11
Reference Protocol No.	PRT/RAS/01/00

 

SITE ADDRESS----------

 

 

 

 

REPORT CONTENTS

 

S. NO.	ITEM DESCRIPTION	PAGE NO.
1.0	Report approval	3
2.0	Overview:	4
2.1	Objective	4
2.2	Purpose  and Scope	4
2.3	Execution Team  and Responsibility	4
3.0	GENERAL CONSIDERATION/PREREQUISITES	4
4.0	RISK ASSESSMENT CRITERIA	5
5.0	RISK ASSESSMENT  PROCEDURE	5
6.0	RISK ACCEPTANCE CRITERIA	5
7.0	UNIT OPERATION REVIEW	5
8.0	FEMA TABLE	6
9.0	RISK IDENTIFICATION SUMARY	7
10.0	RISK MITIGATING TOOLS	7
11.0	RISK PREVENTION TOOLS	8
12.0	DEFICIENCY ,CORRECTIVE AND PREVENTIVE ACTION:	8
13.0	RISK EVOLUTION SUMMMARY	9
14.0	ANNEXURE (S)	9
15.0	RISK ASSESSMENT FINAL REPORT	10
15.1	Summary	10
15.2	Conclusion	10
15.3	Final Report Approval	10
16.0	REFERENCES	11

1.0         Report Approval

     This Report has been approved by the following 

	Name	Department	Designation	Signature	Date
Prepared By
Checked By
Reviewed By

 

Final Approval

Final approval has been given by the following:

	Name	Signature	Date
Approved By (Head – QA)

 

 2.0      Overview:

2.1        Objective

The objective of developing and executing this Report was to access the Risk Associated to Quality of the product with respect to hazards and critical point review, To evaluate the risk priority Number, To identify the risk prevention steps and To identify the risk mitigation tools.

 

2.2        Purpose  and Scope

The purpose of this Report was to verify the actual risk associated with critical operation at formulation Unit -6 Nectar Lifesciences Limited, Barotiwala

 

The Report has defined the risks and determines critical operations. Based upon the initial risk assessment, risk prevention and risk mitigation tools will be designed.

The Scope of the report was limited to conduct risk assessment study at formulation Unit -6 Nectar Lifesciences Limited, Barotiwala.

 

       2.3       Execution team and Responsibility:

        2.3.1. Execution team responsible for the execution of risk assessments study

 

DEPARTMENT	DESIGNATION	NAME	SIGNATURE	DATE
ENGINEERING
PRODUCTION
QUALITY CONTROL
QUALITY ASSURANCE

 

       2.3.2 Responsibility

The following factionaries are responsible to prepare the Report and for Execution of the activity.

Quality assurance officer / Executive – For Preparation of Report

Engineering Head – For execution support

Production Head – For execution support

Quality Control head - For execution support

 

4.0     Risk assessment criteria

Risk Assessment activity has covered all the critical aspects of pharmaceutical quality including raw material management, dispensing, manufacturing, testing and distribution processes throughout the lifecycle of drug substances, drug products.

                           

5.0         Risk assessment  procedure 

·         Risk assessment team identified risk using unit operation review format.

·         Based upon identified risk in unit operation review, risk evaluation had been done and risk priority number identified.

·         Risk priority number was taken into account severity of risk associated delectability and probability of occurrence and take delectability

·         Risk management team was evaluated risk prevention and risk mitigation tools

 

 

·         severity (S),

·         likelihood of occurrence (O), and (Note: This is also often known as probability (P))

·         inability of controls to detect it (D)

 

Each index ranges from 1 (lowest risk) to 10 (highest risk). The overall risk of each failure is called Risk Priority Number (RPN) and the product of Severity (S), Occurrence (O), and Detection (D) rankings: RPN = S × O × D. The RPN (ranging from 1 to 1000) is used to prioritize all potential failures to decide upon actions leading to reduce the risk, usually by reducing likelihood of occurrence and improving controls for detecting the failure

    6.0                                                                                                                                                                                                                                                                           Risk acceptance criteria

·         Severity ranking, occurrence ranking and detectability ranking should not exceed 5.

·         Individual Risk Priority Number should not increase 125.

·         RPN for a given high-risk process must be decreased by 50 percent within 1 year.

         

 

 

 

7.0     Unit operation review

Area /Equipment Code: Strip Packing/ Strip Packing Machine: POSPM-01

Key Operation: Packing of tablets into strips.

Operating Personnel: Ajay

Date of Operation: 10-03-2010

Dept. Officer: Yashwant Singh

 

Sr.No	Unit operation	Standard Practice	Observation	Probability of occurrence	RPN	Remarks
1	Strip Packing Operation of Elpod 50 DT tablet. B.No. CO4702	Tablets fill in the hopper and pass from chutes which drop tablets in to the sealing pocket.	Strip packing Machine break down occur because tablet dropping problem through chute.	Very slight.	6	Probability for occurring this type of problem is very slight.

Part Function	Failure Mode	Effect of Failure	Severity Ranking	Potential cause of Failure	Occurrence Ranking	Possible means of detection/Delectability Ranking	RPN	Preventive actions to be taken
Tablet Packing Operation.	Break down in the strip packing                               machine because of tablets not passing properly through one of the chute.	Due to tablets passing problem empty pocket may occur in strips, broken tablets may pass to strips.	2	Accidentally channels setting might be misaligned..	3	Almost certain because operators and IPQA online checking the process.	6	Trainings of the strip packing machine operator.

9.0      Risk identification summary:

 

              The tablets passing problem through chute was identified during packing operation and the risk for empty pocket and broken tablet may pass into the strips was assessed related to this failure. So the machine immediately stopped and product was removed from the machine and packing line. And after rectifying the problem line clearance was taken again to minimize any risk related to the mishap.

 

 

 

 

 

 

    Sign:

 Date:

 

 

10.0               Risk mitigating tools

 

Risk mitigation was done by rechecking the last shipper packed after machine stopped at 16:05 and unplanned deviation filled for the same.

Next day before using the machine for packing operation line clearance was taken again to minimize any effect of machine stoppage during packing operation.

 

Sign:

Date:

 

11.0       Risk prevention tools

 

          Proper handling of machine change parts and any dismantling/assembling operation should be taken with care.

Operator retrained for the SOP related to strip packing machine operation.

 

 

 

 

 

 

Sign:

Date:

 

12.0     Deficiency, Corrective and Preventive Action

12.1	Deficiency Observed : The chutes for tablets passing might be accidently misaligned.
12.2	Corrective action proposed: Operator should be trained for the operating SOP for the machine.
12.3	Time Fine for corrective action : Immediately.
12.4	Evolution  of Corrective action : To see the result of the training operator will be under observation of the supervisor.

 

Sign:

Date:

 

 

 

13.0     Risk evaluation summary

 

Sr.No.	Description of Risk	Risk Prevention Proposal	Risk Mitigation Tools	Remarks
1.	Because of tablets passing problem through chute Empty pocket may occur in the strip.	Training	Rechecking of last shipper packed after machine stopped	Ok
2.	Broken tablets may pass into the strips.	Training	Rechecking of last shipper packed after machine stopped	OK

 

Sign:

Date:

 

 

14.0    Annexure (s):

 

 

Sr.No.	Annexure No.	Title of Annexure
1	1	Operator’s training record.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

15.0                                                                                                                                                    Risk assessment final report:

                       

15.1	SUMMARY :
The tablet passing problem through on of the chute was identified during packing of ELPOD 50 DT tablet, Batch No.: CO4702. To rectify the problem product was removed from the line and engineering department reset the chutes to correct the nuisance. Next day line clearance was taken again and to check the risk of empty pocket and broken tablet last shipper from the time of machine stopped was rechecked and nothing mishap was found. Risk severity was observed to 2 as per the table provided in RISK MANAGEMENT MASTER PLAN. Risk occurrence was observed to 3. Risk detection rating was 1 (Almost certain) because online checking is there.
15.2	CONCLUSION :
The RPN index for the above said risk was calculated to 6. as per the formula RPN= Severity X Occurrence X Detection. Where severity was 2, frequency for occurrence/ probability was 3 and Risk detection rating was 1. The risk detection occurrence frequency is very slightly and its detection is almost certain because of established system of online checking. The machine operator was trained again immediately for the SOP.

 

 

Sign:

Date:

 

 

 

 

15.3	FINAL REPORT APPROVAL:

NAME	DESIGNATION	DEPARTMENT	SIGNATURE	DATE
		PRODUCTION
		QUALITY CONTROL
		PROJECTS / ENGINEERING
		QUALITY ASSURANCE

 

 

16.0	REFERENCES :

 

1.0	ISO Risk Assessment Guideline No. 14971
2.0	Environmental Risk assessment Guideline of MHRA-Dec.2006
3.0	GAMP-4  Good Equipments Manufacturing Practice version – 4
4.0	Quality Risk Management, USFDA. Oct.2006