The analysis may be qualitative or quantitative in nature, or a combination of the two. Study Group More information. Standard Operating Procedure Title: Identify potential gaps, inconsistencies, and redundancies within the process that had historically been used for replacement parts functional equivalence determinations. A case study in functi
These examples address real-life issues, are straightforward in their application and are designed to engender a general understanding and appreciation of the usefulness of risk management applications in routine decision-making opportunities. Page Part 1 Overview of clinical governance 1 Clinical governance the concept Purposes Why clinical governance The evolution to accountability for patient care quality and safety The. Bring your medical device to market faster 1 My Perspective Work with start up medical device companies Goal: Page 3 of 9 Diagram 1: Risk Assessment and Management. Training curricula were established to define the training and qualificationcriteria for personnel initiating functional equivalence assessments.
The risk methodology selected for the subject case study is: Introduction ICH Q9 – Quality Risk Management provides an excellent high-level framework for the use of risk management in pharmaceutical product development and manufacturing quality decisionmaking applications.
Case study rmwg-o3 functional equivalence for equipment
Quality Risk Management Q9. Bring your medical device to market faster 1 My Perspective Work with start up medical device companies Goal: Risk-based approach used to define a functional equivalence assessment process.
The team concluded that many of the potential fault pathways werealready being appropriately mitigated by robust quality systems such as training,validation, and change control that were performing as intended and areroutinely audited. Correspondingly, Failure Mode Effect Analysis appeared to be the most frequently used methodology for more advanced risk analysis efforts.
Enterprise Risk Management Policy Date: This fault tree illustrates the potential means by which equipment changessuch as parts replacements could pose risk to the validated state functuonal theequipment. Risk Management Concept and Design Construction. This article illustrates the risk analysis guidance discussed in GAMP 4. Preparation for the More information.
During these service lifetimesmanufacturing equipment will likely require both preventive and correctivemaintenance activities that may involve the replacement of parts within thesystems. These principles are aligned with, and in some instances expand beyond, those already defined by ICH Q9 and are included in this report.
In fact, equipmebt is the first risk that banks must manage, even before they make their first More information. Functional Equivalence for Equipment Replacements Study RMWG Selecting a Risk Assessment Method In this case study, the firm elected to craft one risk assessment for the overall generic functional equivalence assessment process in order to achieve two objectives: Specific roles and responsibilities for each functional area participating in functional equivalence assessments should be clearly defined see beige triangles in Figure 2.
It is not necessary or appropriate to always use a formal risk management process e.
Output is a relative risk score for each failure mode. Leading Practice Risk Management Principles.
Please address any comments on this proposal, by 1 October to Dr More information. Best practice in social dialogue in public service reform: Start display at page:.
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Defining the Risk Question The risk question developed for the subject case study is: At this stage of the QRM process, care should be taken to not exclude those operations which may be simply perceived as low risk, without fully evaluating the actual potential influences and associated potential risks involved. Training curricula were established to define the training and qualification criteria for personnel initiating functional equivalence assessments. Method to compare and rank risks Typically involves evaluation of multiple diverse quantitative and qualitative factors for each risk, and weighting factors and risk scores.
Risk assessment used to review and optimize packaging line quality performance. Risk assessment used to define minimum cleaning requirements excludes aseptic and potent compounds. Defining Process Space System: The team concluded that many of the potential fault pathways were already being appropriately mitigated by robust quality systems such as training, validation, and change control that were performing as intended and are routinely audited.
Defining the RiskQuestion The risk question developed for the subject case study is: The team focused on two key areas of risk: