Manufacturing Technology Committee – Risk Management Working Group
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Risk Asssment (Risk Identification, Analysis and Evaluation) Risk Identification -
The risk asssment team assigned to this initiative first prepared a list of all operations and associated supporting systems that had potential impact on product quality. During this stage of the Quality Risk Management (QRM) process, no process were excluded simply becau the process was perceived as “low risk” (reference Table 2 –QRM Output for a partial list of the risk areas identified).
Risk Analysis and Evaluation -
The Risk Analysis stage of the QRM process estimates the potential harm(s) associated with each potential risk. The analysis may be qualitative or quantitative in nature, or a combination of the two.迁户口申请书
In this ca study, the analysis ud was quantitative. The risk score or risk product number (RPN) was determined by multiplying the scores for probability, verity and detectability:
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RPN = Probability Score x Severity Score x Detectability Score
The ranking definitions for Probability, Severity, and Detectability were developed prior to commencing any actual asssment and are summarized in Table 1 –Scoring Scheme for Probabilit
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y, Severity, & Detectability.
After the risk areas were identified, subject matter experts worked to evaluate each risk area and list corresponding failure modes and associated failure effects for each risk area. Subquently, probability, verity, and detectability were determined using the scoring criteria in Table 1. The results were collated to Table 2 and then reviewed to ensure consistency and accuracy. The final output was published for risk prioritization.
酸甜萝卜干Each line item from the asssment was ranked as either a low, intermediate, or high risk depending on the calculated RPN value. A RPN of < 40 was considered a low risk; a RPN of 40 – 99 was identified as an intermediate risk; and a RPN of 100 or greater was defined as a high risk. Risk rankings took into consideration the overall RPN value as well as how significant the issue under asssment was to the development of the product. In many cas, mitigating the larger RPN issues also resulted in a decrea in the calculated RPN for areas with lower identified risks.
To facilitate a better understanding and management of the results defined by Table 2, a color-coded chart was developed to correlate risk-asssment results to anticipated tablet quality, categorized by specific unit process (Figure 1). By summarizing the results in this manner, the project team was
able to e and communicate how the identified risks were inter-related and prioritized (by RPN) for risk mitigation.
Table 1- Scoring Scheme for Probability, Severity, and Ability to Detect
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Table 2 - QRM Output圣诞习俗
(P=Probability; S=Severity, D=Detectability)
Figure 1 - Color Summary Chart of Results in Table 2
