Quantitative Analysis & Evaluation of Risk

 

Quantitative Analysis & Evaluation of Risk

¨  To establish quantitative analysis and evaluation of a risk, Severity, Occurrence and Detectability of a risk are presented by numerical numbers.

¨  These numerical numbers are then used to calculate Risk Priority Number (RPN) for the categorization of risk and its impact.

Severity

Severity (S)	Description	Ranking
Critical	Outcomes may include loss of human, permanent stoppage of the process involved, Recall or some other lawful accusation and may cause highly payable loss	5
Severe	Results may be severe injury, impermanent stoppage of the process involved, Non-compliance to  Regulatory protocols, bad impact on the approved contracts, loss may be high	4 – 4.9
Moderate	Product quality may be effected, violation of GMP and GLP protocols, no health injury, no stoppage of the process and may be result a moderate loss	3 – 3.9
Minor	It involves no risk to user, petty impact process, low financial loss, minor violation of GMP and GLP protocols which may effect quality up to some extent	2 – 2.9
-Negligible	No human risk, No impact on usage or process or Regulatory compliance, insignificant impact on GMP or cost.	1 – 1.9

   Occurrence

Occurrence (O)	Description	Ranking
Almost Certain or Unknown	Recurrent to permanent occurrence or may be unknown which may effect the previous or upcoming batches	5
Likely	Outcomes may be a possible  reoccurrence, concerned batch may have unpredictable results within different units	4 – 4.9
Occasional	Occurrence possibility is expected but no reoccurrence should expected, Isolated cluster in a batch.	3 – 3.9
Rare	It occurs rarely	2 – 2.9
Remote	This may occur for the 1st time or very rarely	1 – 1.9

Detectability

Detectability (D)	Description	Ranking
No control	Unavailability of control parameters, or no protocol of detection of the failure	5
Very Low	Control parameters are available but on sufficient to prevent, or detect the failure.	4 – 4.9
Low	Proper protocols are available but failure occurrence may be possible	3 – 3.9
Moderate	Generally System should detect the failure if happen	2 – 2.9
High	Control parameters and protocols are well sufficient to stop the failure	1 – 1.9

 

Risk Priority Number (RPN)

¨  Risk priority number is a number that reveals the level of the risk i.e Low, Medium or High risk.   

¨  RPN will be calculated by using the following formula:

¨  RPN = Severity x Occurrence x Detection

Criticality Table

RPN (S x O x D)	Risk Level	Actions
64 - 125	High	This situation is at high risk and proper immediate action should be taken to reduce the risk to acceptable level and proper measures should be taken to stop the risk in future.
27 - 63	Medium	The situation is not so much risky. Proper actions are needed to reduce the risk and also future measures should be taken taking in view future plan.
≤ 26	Low	Risk occurrence is within the acceptable limit but proper measures are needed to come out of the risk.

 

Presented By

Muhammad Atif

PhD Scholar Pharmaceutical Sciences AWKUM