Case for Quality Company D. Risk Management

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Shana Freeman
6 years ago
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1 Case for Quality Company D

Introduction to procedure at Company X Establishes requirements for of Medical Devices with regards to Safety Combination of the probability of occurrence of harm and the severity of that harm.

2 Introduction to procedure at Company X Establishes requirements for of Medical Devices with regards to Safety Combination of the probability of occurrence of harm and the severity of that harm. [ISO 497] Systematic application of management policies, procedures and practices to the tasks of analyzing, evaluating, controlling and monitoring risk. [ISO497]. Safety Freedom from unacceptable risk. [ISO 497] for patients, medical device users, and other persons (as well as property and the environment). People exposed to medical devices after production.

Scope of Procedure Applies throughout the entire lifecycle of medical devices and medical systems for which Company X is the manufacturer Lifecycle All phases in the life of a medical device, from

3 Scope of Procedure Applies throughout the entire lifecycle of medical devices and medical systems for which Company X is the manufacturer Lifecycle All phases in the life of a medical device, from the initial conception to final decommissioning and disposal. [ISO 497] Medical Device Any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of () diagnosis, prevention, monitoring, treatment or alleviation of disease, () diagnosis, monitoring, treatment, alleviation of or compensation for an injury, (3) investigation, replacement, modification, or support of the anatomy or of a physiological process, (4) supporting or sustaining life, (5) control of contraception, (6) disinfection of medical devices, (7) providing information for medical purposes by means of in vitro examination of specimens derived from the human body; and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means. [ISO 497] Medical system System containing at least one medical device

Marketing Rep, Clinical Affairs Rep, Regulatory Affairs Rep.

4 Key Terms Team Team responsible for the review of risk management activities (within a defined scope). The Team is a subset of the Project Team (both prelaunch and post-launch) Typical roles: Quality Engineer, Design Engineer, Manufacturing Engineer, Marketing Rep, Clinical Affairs Rep, Regulatory Affairs Rep. Board (RMB) Designated group of subject-matter experts and managers who have responsibility for the supervision of all activities at Company X including authorization to balance medical benefits against residual risks to make final decisions regarding the acceptability of Overall Residual (ORR).

5 Table Table Main table for documenting risk analysis, risk evaluation, and risk control activities ID # Functional Output Hazard Hazardous Situation Harm Person Affected Causes Planned/Existing Control Measures Severity Level (S HARM ) Occurrence Level (O HARM ) Region Additional Control Measures Revised Occurrence Level (O HARM ) Revised Region /Benefit Analysis (required for High/Medium risks) Verification of Control Measures (Implementation) Verification of Control Measures (Effectiveness) Comments/ Rationale necessary) (if

6 Process: 5 Elements Analysis Analysis Techniques Evaluation work instruction Management procedure 3 4 Control ORR Evaluation Critical Quality Attributes work instruction Management Board LAUNCH work instruction 5 Production and Post Production Monitoring Post-Market (Health) Assessment work instruction

7 Management Process Flow

8 From 9.4. Control reduceable by Option Analysis inherently safe design? 9.4. reduceable by protective measures in the device or mfg process? 9.4. reduceable by 9.4. Information for Safety? Document additional risk control measure(s) Estimate the residual risk assuming all (planned/existing and additional) risk control measures will be implemented Process Part II Restrict the Intended Use (Project Strategy) reduceable by restriction of Intended Use? Process Flow (contd.) 3 Control 4 Is further individual risk 9.4. reduction necessary or possible? Residual risk is judged acceptable (pending verification) Are new hazards/hazardous situations introduced or existing risks affected due to additional risk control measures? Do medical benefits outweigh the individual residual risk? DR6 From Identify and communicate failure criticality information pertaining to risk control measures 9.4. is unacceptable. Abort project DR Verify implementation of all risk control measures Verify effectiveness of all risk control measures Overall Residual Evaluation DR9 DR LAUNCH Is risk control complete? (Are all hazards accurately considered?) Individual residual risks are acceptable Is the Overall Residual Consult Acceptable? Management Board 9.5. Is RMB approval required? Overall Residual is acceptable. Complete Report Ensure RMF is released Is further risk Board reduction possible? Do medical benefits outweigh Overall Residual? 5 Production and Post-Production Monitoring Review production and post-production information 9.6. Is re-assessment of risk necessary?

9 Control Overall Residual Evaluation Production and Post-Production Monitoring 4 Are new hazards/hazardous situations introduced or existing risks affected due to additional ORR risk control measures? Evaluation From Identify and communicate failure criticality information pertaining to risk control measures DR6 DR9 DR0 LAUNCH Residual risk is judged acceptable (pending verification) Is the Overall Residual Acceptable? Is RMB approval required? Overall Residual is acceptable. Complete Report Do medical benefits outweigh the individual residual risk? Consult Management Board is unacceptable. Abort project. Verify implementation of all risk control measures (ORR) DR posed by the medical device (i.e., all residual risks documented in the Verify effectiveness of Table all risk control and measures displayed on the Matrix) is evaluated to decide if Is risk the control complete? ORR is acceptable. (Are all hazards accurately considered?) Individual residual risks are acceptable After all risk control measures have been verified, the Overall Residual Is further risk Board reduction possible? Do medical benefits outweigh Overall Residual? 9.6. Review production and post-production information te: It is possible that the ORR can be considered unacceptable even though the Go individual to residual risks 9.6. are acceptable. This is particularly true for Is complex 5 medical re-assessment devices/systems of risk with a large number of individual risks necessary? 7 Ensure RMF is released

10 Control Overall Residual Evaluation 4 LAUNCH Is further individual risk reduction necessary or possible? Are new hazards/hazardous situations introduced or existing risks affected due to additional risk control measures? Verify implementation of all risk control measures DR Any residual risk is in the High (Red) region, Is the Overall Residual Acceptable? 9.4. Overall Residual is acceptable. Complete Report Do medical benefits Residual risk is judged acceptable outweigh the individual (pending verification) residual risk? ORR Evaluation Board The Board (RMB) must be consulted and 9.4. must From is Identify and communicate DR6 unacceptable. failure criticality information pertaining Abort project to risk control measures decide about the acceptability of the ORR if any of the following conditions is true: Verify effectiveness of all risk control measures Any residual risk in the Medium (Yellow) region has severity S3 or higher, or The Is risk control Team complete? requests RMB consultation. (Are all hazards accurately considered?) DR9 DR Individual residual risks are acceptable Is RMB approval required? Consult Management Board Ensure RMF is released. Is further risk Board reduction possible? Do medical benefits outweigh Overall Residual? n 9.6.

11 RMB Members The Board must include, at a minimum, the following five functions (roles):. Head of RA/QA (or authorized designate*). Head of R&D (or authorized designate*) 3. Expert 4. Medical Expert (Clinical Expert) 5. Post-Production Monitoring Expert te : Where a safety representative or comparable function is required by national law, this person or authorized designate must be a member of the Board. te : *Authorized designates must have equivalent or similar organizational responsibility and/or authority.

12 Additional functions (roles) may be added to the Board as needed, for example: Project Leader Technical specialist(s) Manufacturing representative(s) Marketing representative (for perspective on product use) Legal representative (typically only for higher risk products)

ISO INTERNATIONAL STANDARD. Medical devices Application of risk management to medical devices

ISO INTERNATIONAL STANDARD. Medical devices Application of risk management to medical devices INTERNATIONAL STANDARD ISO 14971 Second edition 2007-03-01 Corrected version 2007-10-01 Medical devices Application of risk management to medical devices Dispositifs médicaux Application de la gestion