Quality management system(qrm)

QUALITY RISK MANAGEMENT

1. QUALITY MANAGEMENT SYSTEM SUBMITTED BY :- SUBMITTED TO:- KUMARI SUPRIYA HARSHITA MISHRA

2. CONTENT INTRODUCTION QUALITY RISK MANAGEMENT RISK ASSESSMENT RISK CONTROL RISK REVIEW RISK MANAGEMENT TOOLS HACCP RISK RANGING AND FILTERING CHANGE CONTROL DEVIATION(PLANNED AND UNPLANNED) CAPA

3. INTRODUCTION A QUALITY MANAGEMENT SYSTEM IS :- System for managing the quality of an organization Includes everything in the organization that relates to quality : Products and Services Processes Operations Customer Satisfaction

4. Document Manager Risk Manager Training Record Manager Audits CAPA Supplier Manager Asset Manager TYPES OF QUALITY MANAGEMENT SYSTEM

5. Quality Risk Management The systemic application of quality management policies , procedures and practices to the tasks of assessing, controlling, communicating and reviewing risk .

6. Principle The evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient . The level of effort, formality and documentation of the quality risk management process should be commensurate with the level of risk.

7. Risk Assessment A systemic process of organizing information to support a risk decision to be made within a risk management process. Three parts of risk assessment :- Risk Identification(What might go wrong?) Risk Analysis(What is the probability it will go wrong?) Risk Evaluation(what are the consequences?) (Severity)

8. RISK IDENTIFICATION The systemic use of information to identify potential sources of harm referring to the risk or problem. RISK ANALYSIS The estimation of the risk associated with the identified hazards. It is the qualitative or quantitative process of occurrence and severity of harm.

9. RISK EVALUATION The comparison of the estimated risk to given risk criteria using a qualitative or quantitative scale to determine the significance of the risk. RISK=PROBABILITY*SEVERITY*DETECTABILITY

10. Risk Control( Decision Making Activity ) Actions implementing risk management decisions. The purpose is to reduce the risk to an acceptable level. The amount of effort used in risk control should be proportional to the significance of risk. Two parts of risk control :- Risk Reduction Risk Acceptance

11. Risk Reduction Actions taken to lesson the probability of occurrence severity of the harm. Risk reduction measures might introduce new risks into the system or increase the significance of other risks. Revisit risk assessment to identify and evaluate any possible change

12. Risk Acceptance The decision to accept the risk The best quality risk management might not entirely eliminate risk The quality risk is reduced to a specified acceptable level which will decided on a case-by-case bass.

13. Risk Communication The sharing of information about risk and risk management between the decision maker and other stakeholders. Parties communicate at any stage of process The output/result should be appropriately communicated and documented

14. Risk Review Review or monitoring of output/results of the risk management The process should be utilized for events (planned or unplanned events) The frequency of a ny review should be based on the level of risk Risk review might include reconsideration of risk acceptance decisions

15. List O f Risk Management Tools Basic risk management facilitation methods Failure Mode Effects Analysis ( FMEA) Failure Mode, Effects and Critically Analysis (FMECA) Fault Tree Analysis (FTA) Hazard Analysis and Critical Control Points (HACCP) Hazard Operability Analysis (HAZOP) Preliminary Hazard Analysis (PHA) Risk ranking and filtering

16. HACCP(SEVEN PRINCIPLE)

17. RISK RANKING AND FITERING It is a tool for comparing and ranking risks which requires the evaluation of multiple qualitative and quantitative factors for each risks. This tool involves in breaking down a basic risk question into as many component as needed to capture factors involved in the risk Potential Areas of Uses:- Used to prioritize manufacturing sites for inspection/audits by regulators or industry. Useful when management needs to evaluate both quantitatively-assessed risks and qualitatively-assessed risks within the same organizational framework.

18. CHANGE CONTROL CHANGE CONTROL CONTD .

19. CHANGE CONTROL CONTD. To make or become different from expected. Types of change :- Project Change Product Change Potential impacts need to be considered when evaluating a change request : Scope,Schedule,Cost,Quality,Process and Deliverable,Risk .

20. DEVIATION (PLANNED AND UNPLANNED) Quality Risk Management was mainly designed to be used prospectively when manufacturing operations are defined and validated. Therefore, potential deviations are identified and avoided by implementing risk control measures and preventive actions .  Event Detection  Decision Making Process / Deviation Categorization  Deviation Treatment  Root cause investigation  CAPA

21. Permanent Planned Unplanned Product Impacted Minor or Major Negligible Impact Impact Request Corrections Deviation Initiation Investigation Engineering Approval Production Approval QA Approval Closed Approved/Rejected Initiate Change Control Initiate Nonconformance Initiate CAPA

22. Implementing A CAPA System With A Closed Loop

23. Corrective Action And Preventive Action The root cause investigation process is a key step in handling major and critical deviations as it will provide objective evidence to implement corrective and possibly preventive actions as part of the CAPA system. Corrective Actions are taken to eliminate the root causes of deviations, and should be based on good quality investigations. Corrective actions should be QA approved before implemented and their efficacy verified in a documented manner, activity that could require a significant period of time. Corrective actions could be transferred to an independent CAPA system to avoid unnecessary delay for deviation closure. This independent CAPA system should include tracking of all actions required by a pre-approved CAPA plan and effectiveness check.