TITLE: Line X Cap Inspection Vision System Risk Assessment / Rev. 0 Page 1 of 3
SCOPE
The scope of this risk analysis is to determine, based on Risk, the number of Performance Qualification runs required to appropriately qualify the Line X Cap Inspection Vision System.
RISK ANALYSIS METHODOLOGY SELECTED
Based on the Guidance for Industry “Q9 Quality Risk Management,” risk is defined as the combination of the probability of occurrence of harm and the severity of that harm. According with this definition, it is determined that the risk evaluation is linked to the patient safety which is directly proportional to product quality. Therefore, the risk assessment for this project scope shall be focus on product quality impact.
The Guidance for Industry “Q9 Quality Risk Management” on section C “Risk Assessment” page 4 states three fundamental questions that are often helpful during the risk assessment process:
1. What might go wrong (or potential risk)?
2. What is the likelihood (probability) it will go wrong?
3. What are the consequences (severity)?
The risk priority model tool provides an easy and comprehensive way to answer those questions in addition to provide a rational for each decision. See the table Risk Assessment table below.
First, the Severity and the Occurrence rates are used to determine the Risk Class. Then using the Risk Class and Detectability level, the overall Risk Priority is determined. Based on the three possible Risk Priority of Low, Moderate, and High, the following numbers of the PQ will be executed on the process.
Low: One (1) PQ run using any bottle/cap configuration run.
Moderate: Three (3) PQ runs using the three (3) different bottle/cap configurations.
High: Three (3) PQ runs per bottle/cap configuration run.
Risk Assessment table
Source: 14.1.10-NFORM-1.
Description / To determine the amount of PQ run(s) to be performed.
Potential Risks / Major potential risk is that the bottle/cap configurations packaged at Line X do not meet the cap requirements and could impact the product sterility.
Assessment / Select Rating (Low, Moderate, High) / Rationale
Severity / High / Lack of appropriate cap inspection may allow compromised product to go undetected.
Occurrence / High / The occurrence is considered high since inappropriate placement or missing cap occurs daily during normal production schedule.
Risk Class (Severity vs. Occurrence) / Red=Risk Class 3
Detectability / High / If the Line X Cap Inspection Vision System fails to properly perform its functions, an operator stationed at the first accumulator table for inspection to remove bottles with crooked caps and an In-Process Checks is performed hourly. The Cap Inspection Vision System will be capable to detect the missing caps, crooked caps, missing cap sections and open caps.
Risk Priority (Risk Class vs. Detectability) / Yellow=Moderate Risk
CONCLUSION
Based on the above Risk Priority being determined to be “Moderate,” three (3) PQ runs will be performed using three (3) different bottle/cap configurations. This numbers of PQ runs will sufficiently confirm the repeatability of the three different bottle/cap configurations given the process’s Risk level. The qualification will be performed using the three different cap types (i.e. screw, flip top and tethered) as available and dictated by the equipment setup(s) for scheduled production. If the run fails, then as part of the protocol discrepancy report it will be evaluated to determine the amount of PQ runs to be tested.
The signatures below indicate agreement with the conclusion of this Risk Assessment for Line X Cap Inspection System Risk Assessment.
APPROVAL SIGNATURES / DATESAuthor: / Date
Validation: / Date
Operations/Manufacturing: / Date
Engineering: / Date
Quality Assurance: / Date