sop for quality risk assessment

sop for quality risk assessment


1.1 To provide a guideline for conducting risk assessment.
1.2 Provide the systematic approach to achieve the quality standards by assessing, controlling, communicating and reviewing risks related to product quality, safety and efficacy, System, Process, Facility, Document and Environment.
2.1 This procedure is applicable to all equipment, Process, facilities, manufacturing operation which are likely to effect the product or process and investigating root cause of product complaints, OOS, deviation, Incidents and any other problem at all products manufactured
3.1 Asst. Officer or above–Quality assurance – Prepare the SOP and follow-up the SOP accordingly
3.2 Asst. Manager – Quality Assurance-
3.2.1 Conduct product quality risk assessment for each product manufactured in the site.
3.2.2 Document and approval of quality risk assessment for each product Manufactured in the site
3.2.3 Establish better controls wherever required
4.1 Head QA–
a. Formation of risk Assessment team and team leader.
b. To review, evaluate, Advice and authorize corrective action generated by team.
4.2 Risk Assessment team –
a. Preparation of process parameter involved, Specification for each stage.
b. Identifying all potential failure with respect to equipment, facilities, manufacturing, process, packing, System and Personnel.
c. Preparation of action plan in case of higher RPN and communicate to Head-QA.
5.1 ICH Q9

6.1.1 Risk: The combination of probability of occurrence of harm and severity of harm.
6.1.2 Effects: The results of an action or inaction (that result or could results from cause).
6.1.3 Failure Mode: Different ways that a process or sub process can fail to provide the desired results.
6.1.4 Failure Mode Effect Analysis (FMEA): A “systematic method of identifying and preventing product process problem before they occur”. It is primarily to evaluate a process prior to its implementation.
6.1.5 Risk Priority Number (RPN): The risk priority Number or RPN is a numeric assessment of risk assigned to a process, or steps in a process as part of FMEA. Each failure mode gets a numeric score that quantifies likelihood of occurrence, likelihood of detection and severity of impact.
RPN = severity rating x Occurrence x detection
6.2 Head QA shall assign the team member and team leader for the conducting the FMEA of any Process, system, facilities, Equipment, document, and environment. Team shall have all experienced personnel from different area of work. It shall consist of one person from QA, QC, production, Engineering, warehouse and any other relevant department.
6.3 Team shall identify the Process, system, facilities, Equipment, document, and environment to be examined.
6.4 Justification shall be provided for selecting the item.
6.5 FMEA number shall be assigned by QA for each risk assessment as follow:
FMEA : Failure Mode and Effective Analysis
S : Subject – Name of Equipment/process/ System/Facilities/ Any other
ZZ : Last two digit of current year
NN : Serial Number starting from 01
6.6 Log of FMEA shall be maintained by QA and all entries shall be recorded.
6.7 Prepare the flow chart or detailed process flow of any process/ System/ facilities/ Equipment under FMEA examination and attach the same to FMEA as annexure.
6.8 Team member shall mention all the details of function and malfunction of equipment/process/ facilities/ product/any other for which FMEA needs to be performed.
6.9 Determine which of the step in process constitute “Function” and identify the element of variation in equipment/ Process/ facilities/System/ any other
6.10 Determine which function represents potential “Failure Mode” or point of potential failure Worst potential Effect or consequences of each failure modes, causes of failure modes.
6.11 Identify the controls which are likely to reduce the failure mode, reduce the severity of an effect or detect the occurrence of failure mode. Example are BMR, BPR, validation, SOP, alarms system etc.
6.12 Assigning of severity Number, Occurrence Number and detection Number shall be as follows:

Severity Occurrence Detection
No Effect on out put Failure Unlikely Flaw less detection


Minor effect Remote failure Will detect failure
Moderate Effect Occasional


Might detect failure
Serious effect High failure Almost certain not to detect failure
Hazardous effect Failure certain Lack of detection


6.13 The multiplication of three rating is the risk priority number. For Example if Severity rating is 3, occurrence is 2 and detection is 1 then RPN is 3 x 2 x1 = 6. depending upon the RPN number decision shall be made:
a. Failure shall be accepted if RPN is within the acceptable level.
b. Depending upon the type of failure appropriate action plan to be implemented to control or reduce the occurrence to an acceptable level, if not detection system shall be improved.
c. In some cases failure shall be totally eliminated.
6.14 RPN determines the criticality of failure mode and helps to determine whether the risk of failure should be accepted, controlled or eliminated.
6.15 FMEA shall be used to analyze the current and evaluate the potential impact of any change in equipment/process/facility/ system/any other or any change. Each time new RPN shall be assigned, if RPN is high then priority shall be given to such items and based on current control measures, action plan for traditional measure required shall be made.
6.16 Acceptance Criteria: In case the calculated RPN rating is greater than 50 that particular shall not be acceptable

RPN Rating (SxOxD) RPN Category
76 to ≤ 125 Critical
51 to 75 Major
26 to 50 Moderate
Up to 25 Minor

a. If RPN rating is ≤ 25, no action plan is required.
b. Action plan is required if any of the individual severity, occurrence and detection is high (if RPN is within acceptance criteria).
6.17 Considering the acceptance criteria action plan shall be drawn with responsibility and target date. The effectiveness of these plan shall reviewed by the team member if required support of senior management shall be taken.
6.18 Examples of Risk identified included but not limited.
6.18.1 Risk to manufacturing equipment such as equipment down time, equipment damage, cost of replacing equipment part and potential injury.
6.18.2 Quality of the finished product.
6.18.3 Incorrect Composition.
6.18.4 Raw material and packaging material error.
6.18.5 Mix up.
6.19 Implementation shall be through the change control system shall be implemented and reviewed.
6.20 Risk Communication shall be given by team member to the other concern department/senior management.
6.21 FMEA shall be reviewed after the six month till all RPN reduced to ≤ 25or risks are reduced to acceptable level. A review is also necessary at change of product, process and specification. If there is no change review to be done after 3 year.
6.22 Documentation:
6.22.1 Failure Mode And Effective Analysis – Format
6.22.2 FMEA Action Planning Sheet- Format


SOP : Standard Operating Procedure
QA : Quality Assurance
NA : Not Applicable
RPN : Risk Priority Number
FMEA : Failure Mode and Effective Analysis

Annexure-I Failure Mode and Effective Analysis
Annexure-II FMEA Action Planning Sheet





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