CASE STUDY RMWG-O3 FUNCTIONAL EQUIVALENCE FOR EQUIPMENT

The level of documentation of the risk management process to render an appropriate risk assessment should be commensurate with the level of risk. Case study is appropriately simple and succinct to assure clear understanding. Tool assumes that risk events are caused by deviations from the design and operating intentions Uses a systematic technique to help identify potential deviations from normal use or design intentions. The greatest number of case studies reviewed by the Working Group addressed Quality System e. 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. Adverse findings or trends identified during these reviews would provide indication whether the risk assessment needs to be revised. Emerge Leadership Case Study:

This article illustrates the risk analysis guidance discussed in GAMP 4. Case study provides areas for decreased and increased response actions. If the risks are not sufficiently More information. 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. Other Product Development Risk Tool: Change control considerations are greatly facilitated when replacement parts are exactly identical to the original parts.

Some examples demonstrated the power of combining tools to help in more complex analysis.

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Tavaana Exclusive Case Study: Risk Assessment and Management Allen L. Risk Management Concept and Design Construction. Upon these examinations, the team noted the followingobservations regarding the process that had historically been used forreplacement parts functional stury determinations: Annex 2 WHO guidelines on quality risk management 1.

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case study rmwg-o3 functional equivalence for equipment

Quality risk management process 70 3. Risk Control For each of the two areas of significant risk identified in the FTAs andsummarized above, associated risk control plans were established. Please download to get full document. Study Group More information.

Case_Study_RMWG-03_-_Functional_Equivalence_for_Equipment_Replacements_(rev_1)

September Share an applied and practical approach to perform. The output of the QRM process and associated risk analysis justifying the approach, should be documented and endorsed by the site quality unit.

Glenn George, Kenneth Imler. Case Studies Eight industry examples of quality risk assessment applications are provided below.

Quality Risk Management Principles and Industry Case Studies

Defining the RiskQuestion The risk question developed for the subject case study is: To make this website work, we log user data and share functioanl with processors. All materials on our website are shared by users.

case study rmwg-o3 functional equivalence for equipment

Beyond Your Zapos Case Study: Defining Process Space System: It is not necessary or appropriate to always use a formal risk management process e. Market stock out patient impact of non-medically significant products.

Risk to More information. Sutton Coldfield grammar school for girls case study Preparation for the More information. Evaluation of risks, when stuvy, should ultimately be linked to the protection of the patient.

Case study rmwg-o3 functional equivalence for equipment

Enterprise Risk Management Policy Name: 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.

General Principles and Practices.

case study rmwg-o3 functional equivalence for equipment

Access manufacturing processes, facilities, and equipment Commonly used to evaluate process safety hazards. The functional equivalence assessment process was historicallydependent upon human judgment, expertise, and experienceProcess risks potential breakdowns of the process were qualitative innature, and were difficult to quantify with specificityGiven these observations, the risk assessment team selected Fault Tree Analysis FTA as the risk assessment method since it is well suited for analysis ofqualitative fault conditions that may be related to human performance factors.

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As such, inclusion here is not intended to codify the resulting individual conclusions from a quality perspective, which would have required, at least for some of the models, a greater degree of familiarity with the specific applications, data inputs, and subject matter, and was not within the scope of the initiative.

Diagram 1- Quality Risk Evaluation Pyramid. 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.

Incorrect functional equivalence assessment Technical Services: The Initiator petitioner and preliminary data collector for functional equivalence evaluations should be a Subject Matter Expert SME that is appropriately trained and qualified to craft accurate initial assessments see green triangles in Figure 2. There is generally no single best choice for any given assessment process, and the selection of the appropriate risk methodology should be based on the depth of analysis required, complexity of the subject risk of concern, and equvialence familiarity with the assessment tool.