Quality Risk Management


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What are the process of a well-defined Risk Assessment. When taken in sequence, support better Decision Making by contributing to a greater insight into risks and their impacts.

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Quality Risk Management

  1. 1. Quality Risk Management Quality Risk Management1.800.782.0580 | www.busintellsol.com | info@busintellsol.com
  2. 2. Quality Risk Management Process consisting of well-defined steps which, when taken in sequence, support better Decision Making by contributing to a greater insight into risks and their impacts. It includes elements such as risk identification, assessment, mitigation, elimination and communication. Risk= probability and severity1.800.782.0580 | www.busintellsol.com | info@busintellsol.com
  3. 3. What is the problem being solved • Product may not be available to patients, when needed • May increase the potential for the release of unacceptable product to the market • New product introductions to the marketplace may be delayed • Delays may occur during implementation of changes and improvements to processes • Safe and effective drugs may be discarded or recalled from the market • Manufacturers may be reluctant to implement new technologies or continuous improvements to the products or processes • Scarce resources may not be optimally allocated • Lack of appropriate data to evaluate risk most effectively1.800.782.0580 | www.busintellsol.com | info@busintellsol.com
  4. 4. Benefits – Enhanced patient confidence in decision making on pharmaceutical quality – Promotes more effective use of regulatory agency and industry resources – Establishes a systematic, well-informed and thorough method of decision making which leads to greater transparency and predictability – Increased knowledge of exposure to risk – Fosters quality by design, continuous improvement and new technology introduction, which generally leads to enhanced product quality1.800.782.0580 | www.busintellsol.com | info@busintellsol.com
  5. 5. Process 1. Initiate Process 2. Assess 3. Control 4. Communicate 5. Review1.800.782.0580 | www.busintellsol.com | info@busintellsol.com
  6. 6. Guiding principles • The evaluation of the risk should ultimately link back to the potential risk to the patient. • The extent of the risk management process should be commensurate with the level of risk associated with the decision. • A more robust data set will lead to lower uncertainty. • It is essential to have a clear delineation of the risk question. • Risk management should be an iterative process. • People who apply risk management should have the appropriate training, skills and experience. • The risk management process should be appropriately documented and verifiable.1.800.782.0580 | www.busintellsol.com | info@busintellsol.com
  7. 7. Guide to initiating risk management • Defining specifically the risk management problem or question, including the assumptions leading to the question. • Assembling background information and data on the hazard, harm or human health impact relevant to the assessment. • Defining how the assessment information and conclusions will be used by the decision makers. • Identifying the necessary resources, members of the team who have the appropriate expertise, with the leader clearly identified. • Asking the right risk assessment question(s) • Stating clearly the assumptions in the risk assessment • Assessing the quality and sufficiency of relevant data • Specifying a timeline and deliverables for the risk assessment1.800.782.0580 | www.busintellsol.com | info@busintellsol.com
  8. 8. Risk Assessment – What can go wrong? – What is the likelihood (probability) it would go wrong? – What are the consequences? • Risk analysis is a systematic use of information to identify specific sources of harm (hazards) and to estimate the risk. • Risk evaluation compares the estimated risk against given risk criteria using a quantitative or qualitative scale to determine the significance of the risk.1.800.782.0580 | www.busintellsol.com | info@busintellsol.com
  9. 9. Risk Control Risk control describes the actions of implementing risk management decisions. – What can be done to mitigate and reduce risks? – What options for controlling risks are available? – What are the impacts of current risk management decisions on future options for risk management? • Risk mitigation focuses on a reduction of severity of harm. • Risk reduction focuses on the reduction of probabilities of occurrence of harm and detection of harm. • Risk acceptance is a decision to accept risk, i.e., no additional risk control activities are necessary at that time.1.800.782.0580 | www.busintellsol.com | info@busintellsol.com
  10. 10. Risk communication • Risk communication is the exchange or sharing of information about risk and risk management between the decision maker and other stakeholders. The information can relate to the existence, nature, form, probability, severity, acceptability, treatment, detectability or other aspects of risks to quality. • The communication among stakeholders concerning quality risk management decisions can be made through existing channels.1.800.782.0580 | www.busintellsol.com | info@busintellsol.com
  11. 11. Risk monitoring and review • All risk management processes are dynamic/iterative. • Quality risk management when applied should benefit from new knowledge with each decision cycle and used to enhance future decisions allowing for continuous improvement.1.800.782.0580 | www.busintellsol.com | info@busintellsol.com
  12. 12. Initiate Process flow Risk Management Process Risk Assessment Risk AnalysisRisk Management tools & statistic toolbar Risk Evaluation (Resources, Interfaces & Line functions) Risk Control Risk Mitigation (incl. elimination and avoidance) [Severity] Risk Reduction [Probability] Risk Acceptance Risk Communication Output / Results of the Review Risk Management Process (e.g. Inspections/Audits, Complaints) No additional risk
  13. 13. Risk management Tools 1. Process mapping 2. Preliminary Hazard Analysis (PHA) 3. Hazard Analysis of Critical Control Points (HACCP) 4. Hazard Operability Analysis (HAZOP 5. Fault tree analysis (FTA) 6. Failure Mode Effects Analysis (FMEA) 7. Failure Mode, Effects and Criticality Analysis (FMECA) 8. Risk Ranking and Filtering 9. Informal Risk Management 10. Taguchi, variation risk management method1.800.782.0580 | www.busintellsol.com | info@busintellsol.com
  14. 14. Supporting Statistical Tools • Design of experiments (DOE) • Process Capability Analysis • Control charts: 1. acceptance control charts 2. Shewhart control charts 3. Accumulative sum charts1.800.782.0580 | www.busintellsol.com | info@busintellsol.com
  15. 15. Integration of Quality Risk Management into Operations 1. Development (e.g. Specification Setting, Test Method Selection and process development). 2. Regulatory scrutiny during pre and post approval. 3. As a component of Quality systems ( e.g. Auditing, Deviations/Discrepancies, Complaints & Recall Management, Change management) 4. Facility systems management ( e.g. Design, Hygiene, Qualification, environmental control, Preventative maintenance and Computerized systems) 5. Materials Management (e.g. Supply chain, Assessment and evaluation of suppliers and contract manufacturers, procurement and release of material)
  16. 16. Integration of Quality Risk Management into Operations (Continued) 6. Production (e.g. PAT, Validation, in-process sampling, testing, reporting and trending) 7. Laboratory controls (e.g. validation, testing, methods development, stability). 8. Packaging and labeling (e.g. Selection of container closure system and label controls). 9. Regulatory Authority Activities1.800.782.0580 | www.busintellsol.com | info@busintellsol.com
  17. 17. Definitions• Decision Maker - process owner of risk management process• Dynamic / Iterative Process - TBD• Harm – Damage to health, including the damage that can occur from loss of product efficacy, safety, quality or availability• Hazard - the source of harm. Can be a chemical, biological or physical substance, or an event that can cause harm.• Product Lifecycle – All phases in the life of a product covering both the inherent characteristics of the product and how these may change over time. The lifecycle is from the initial development through pre- and post-approval until the product’s discontinuation and includes the associated regulatory processes.• Quality – Degree to which a set of inherent characteristics of a product, system or process fulfills requirements• Quality System – A formalized system that documents the structure, responsibilities and procedures required to achieve effective quality management.• Requirements – Needs or expectations that are stated, generally implied or obligatory by the patients or their surrogates (e.g. health care professionals, regulators and legislators)• Risk – Combination of the probability of occurrence of harm and the severity of that harm (from ISO/IEC Guide 51)• Risk Management – Process consisting of well-defined steps which, when taken in sequence, support better Decision Making by contributing to a greater insight into risks and their impacts. It includes elements such as risk identification, assessment, mitigation, elimination and communication.• Severity – Measure of possible consequence of a potential source of harm• Stakeholder - Any individual, group or organization that can affect, be affected by, or perceive itself to be affected by a risk. The decision makers might also be stakeholders. For the purposes of this guideline, the primary stakeholders are the patient, healthcare professional, authority, regulator, industry, business, customer.
  18. 18. Business Intelligence Solutions | 1.800.728.0580 | www.busintellsol.com1.800.782.0580 | www.busintellsol.com | info@busintellsol.com