Manufacturing Equipment Risk Assessment

​1.0 PURPOSE

Prepose of this risk assessment is to assess the risk associated with the Risk Assessment for Fourier Transform Infrared Spectrophotometer (FTIR) with the guidance of the Risk Management manual of and ICH Q9.

2.0 SCOPE

This QRM document is applicable to the design, installation, operation, performance and safety of Risk Assessment for Fourier Transform Infrared Spectrophotometer (FTIR)  and identify its failure mode.

10.0 RISK MANAGEMENT TOOL

10.1 Qualitative Risk Management

10.1.1 Risk Identification

Identification of possible risk and damage to critical components, functions and processes.

10.1.2 Risk Analysis

Estimation of the possible risk to the product quality, operator, Machine and environment safety; if those components, functions and processes fail.

10.1.3 Probability Of Occurrence (O)

Occurrence (O) refers to the probability that a specific cause will result in a specific failure mode. The Probability of Occurrence is evaluated and graded as high (will probably occur), medium (may occur at some time) or low (unlikely to occur in most circumstances).

10.1.4 Severity (S)

Severity is the measurement of the possible consequences of a hazard.

The Severity is evaluated and graded either as high (very significant non-compliance with GMP or injury to patients), medium (significant non-compliance with GMP or impact on patients) or low (minor infringement of GMP and no impact on patients).

10.1.5 Probability Of Detection (D)

Probability of Detection is the ability to discover or determine the existence, presence, or fact of a hazard.

The Risk Level is evaluated and graded as high (unlikely to be detected in most circumstances – detection Low), medium (may be detected at some time – detection Medium) or low (will probably be detected – detection High).

10.1.5 Risk Evaluation

Risk evaluation will be done following qualitative method, the factors Probability of Occurrence (O), Severity (S) and Probability of Detection (D) must be graded as low, medium or high as shown in the following table:

The Overall Risk Level is defined according to Combination of Severity and Occurrence to get a Risk Class first and then Combination of Risk Class & Detectability to determine overall risk

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