In this case study, a risk management approach was taken by the firm to identifythe following: Glenn George, Kenneth Imler, More information. An example checklist from the Engineering functional area is shown below in Figure 3 Figure 3 — Engineering Functional Equivalence Determination Checklist Areas of Consideration Materials of construction and ratings Composition of process-contact parts Compatibility with process Surface finishes Typical Characteristics of Functionally Equivalent Parts Assessment Performed By Comparable materials of construction for wetted surfaces Parts designed to operate at expected process extremes heat, pressure, chemistry, etc. Empowering the Quality and Regulatory Compliance Functions Empowering the Quality and Regulatory Compliance Functions Management must take steps to ensure that regulatory and quality compliance is everyone s responsibility. Managing Risk at Bank of America Corporation Overview Risk is inherent in every material business activity that we undertake. There are no medical device examples included in this report, although the case studies and tools shared herein are equally relevant to device manufacturing.
While the list is not inclusive of all available risk assessment methodologies, it represents some of the more frequently used approaches. Ganeshkumar Palanichamy Abstract Medical devices developed for human application are used for diagnostic or treatment More information. Risk can only be effectively managed when it is identified, assessed, considered for further mitigation and communicated – This principle embodies the four general stages to an effective quality risk management process as defined by ICH Q9: In assembling this collection of case studies, the document authors recognized that it may also be beneficial to provide some additional background on several of the core risk methodologies. Topics Background for changes and expectations of regulatory More information.
Prestige Institute More stuxy. Upon these examinations, the team noted the following observations regarding the process that had historically been used for replacement parts functional equivalence determinations: In the development of the Risk Question, it is important to first consider if there is any potential impact of the proposed actions to the patient.
Risk to More information.
Quality Risk Management Principles and Industry Case Studies – PDF
These case studies were selected against a core set of criteria see Introduction above designed to identify models that embody the intent and spirit of ICH Q9. Quality risk management process 70 Annex 2 WHO guidelines on quality risk management 1. The Initiator petitioner and preliminary data collector for functionalequivalence evaluations should be a Tsudy Matter Expert SME that isappropriately trained and equivwlence to craft accurate initial assessments see green triangles in Figure 2.
Quality Risk Management Version 1.
How to write an introduction for an informative speech Nov 18, Standard Operating Procedure Title: Ganeshkumar Palanichamy Abstract Medical devices developed for human application are used for diagnostic or treatment More information. This course will take you through five modules of information to introduce you to the concepts behind risk-based monitoring, More information.
Community Energy Case Study: Risk Assessment and Management. Specific roles stydy responsibilities for each functional area participating in functional equivalence assessments should be clearly defined see beige triangles in Figure 2.
Department oflabor,minesafetyandhealthadministration Safety Manual No. Parts replacements must be performed under the appropriate change controls to ensure that manufacturing equipment remains in a validated state with respect to installation, operation, and performance.
Risk assessment must take into account the probability of a negative event in combination with the severity of that event This principle also serves a useful working definition for risk i.
Each study was graded against six criteria to assess applicability, usefulness and alignment to ICH Q9, and the resulting set of highest graded cases studies were subsequently measured against two additional criteria to ensure a balanced mix of examples for this report re: In this case study, a risk management approach was taken by the firm to identifythe following: Defining Process Space System: Identify potential gaps, inconsistencies, and redundancies within theprocess that had historically been used for replacement parts functionalequivalence determinations.
It is equally important to pre-define the potential resulting risk categorizations so as to not be influenced by the assessment results in defining appropriate response actions.
Case study rmwg-o3 functional equivalence for equipment
Risk assessment used to define minimum cleaning requirements excludes aseptic and potent compounds. Glenn George, Kenneth Imler. Collectively, these components are to be assessed first and foremost with regard to the potential impact to the patient re: Defining the RiskQuestion The risk question developed for the subject case study is: During these service lifetimes manufacturing.
Pharmaceutical Quality Management System: September Share an applied and practical approach to perform More information. Pharmaceutical Quality System Bringing cgmp into the 21 st Century.
This approach minimized both gaps and redundancies in the assessment efforts, while providing a common assessment record format to facilitate overall review of the assessment package. Regulatory Expectations for GMP: 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.
Facility Bio-containment Inactivation System: