ASSESSING THE ROBUSTNESS OF A QUALITY RISK MANAGEMENT PROGRAM

Transcription

1 ASSESSING THE ROBUSTNESS OF A QUALITY RISK MANAGEMENT PROGRAM Amanda Bishop McFarland Senior Quality Risk Management and Microbiology Consultant ValSource, LLC. ABOUT AMANDA & HOME SWEET HOME Cary, North Carolina I LOVE Pain/ng, hiking and cooking WORK EXPERIENCE Senior Consultant with ValSource >15 years industry experience Quality Control, Quality Assurance, Risk Management, Training, Knowledge Management, Low Bioburden Manufacturing SKILLS # Risk facilita/on Developing and mentoring risk facilitators Custom risk tool crea/on Microbiology Risk maturity assessment VOLUNTEER! Co-Lead PDA Quality Risk Management Interest Group Crea/on QRM course material for PDA s training ins/tute and cer/ficate programs. CONTACT " amcfarland@concordiavalsource.com Linkedin! 1

2 AGENDA 1 QRM Cultural Maturity: Outline three elements of a robust risk management program 2 QRM Technical Maturity: Risk Ac>vity Robustness 3 Developing program assessment criteria Ac#vity Evaluate the maturity model provided and iden2fy where your organiza2on is on the model. 2

3 THREE ELEMENTS OF A RISK MANAGEMENT PROGRAM THREE ELEMENTS OF QRM PROGRAM: PEOPLE Facilitators Champions Leadership Individuals who are trained to facilitate risk assessments Have the in-depth knowledge of risk assessment methodologies Individuals who encourage the use of risk management Engage with the site to iden<fy where riskbased thinking should be applied Communicate with leadership regarding site risks Provide resources to ensure risk activities can be completed timely and effectively Engaged in the risk management process Role aligns with ICHQ9, ICHQ10, ISO14971, ISO9001 3

4 THREE ELEMENTS OF QRM PROGRAM: PEOPLE (CONTINUED) Company Wide QRM Awareness Training Less Formal Risk Tools (i.e., REM, decision trees) Formal Risk Tools (i.e., FMEA, HACCP) Risk FacilitaCon Training THREE ELEMENTS OF QRM PROGRAM: DOCUMENTS Risk Policy Standard Opera4ng Procedures Risk Register 4

5 RISK MANAGEMENT POLICY Outlines the QRM program at a high level Defines: When is risk management/risk-based thinking employed How are risk management activities documented Where are risk related documents stored When are risk assessments reviewed RISK SCALES Provide the context by which assessments are evaluated Example Severity Criteria 1 : Severity Rank Compliance Process Consent Decree / Safety mishap, harm Catastrophic 5 Closure to staff Warning Letter, Critical 4 Rejected Batch Recall, Marginal 3 Negligible 2 Observations (483), Major Deviation Minor deviation or internal audit Observations Low 1 No Compliance Effect Batch rework, reprocess Yield loss Delay in downstream processing 1 Used by permission from Dr. Mike Long, ValSource, LLC 5

6 RISK TOOL SOPS Outlines the risk management tools (FMEA, HACCP, informal risk tools, etc.) Describes where and how to use risk tools Defines the appropriate time to employ a risk management tool Reactive Proactive Provides the context for when to use a formal or less formal tool INTEGRATION OF QRM: ICHQ10 Pharmaceu+cal Development Technology Transfer Commercial Manufacturing Product Discontinuation Investigational Products GMP Management Responsibili+es Change Management Correc+ve Ac+on (CAPA) System Management Review Enablers Knowledge Management Quality Risk Management 6

7 INTEGRATION OF QRM Robust QRM programs will be integrated throughout various quality systems Examples: Opera=ons/manufacturing Technology transfer/ new product introduc=on Supplier selec=on Valida=on/qualifica=on Environmental monitoring Devia=ons/Inves=ga=ons Documenta=on Training and educa=on Defects Audi=ng/inspec=on Change management/change control Quality Control THREE ELEMENTS OF QRM PROGRAM: GOVERNANCE Strategic Focus and Vision for future of organiza3on Responds to risk iden3fica3on and provides the framework to respond 3mely Risk Communica3on Process of monitoring and reviewing risks 7

8 RISK REGISTERS Captures the most cri/cal risks at your organiza/on for review and ac/on Risk Assessment Tracking Number Hazard Risk Level System Impacted RA Viral Contamination High Operations RA Calibration 1 year overdue High Packaging RA Equipment failure Medium Validation EXAMPLE GOVERNANCE STRUCTURE Corporate Business Units (Development) Escalation Business Units (Biologics) Business Units (Medical Devices) Development (R&D Site) Development (R&D Site) Biologics Site Escalation Biologics Site Medical Device Site Cri<cal Risk Iden<fied 8

9 Agenda 1 QRM Cultural Maturity: Outline three elements of a robust risk management program 2 QRM Technical Maturity: Risk Activity Robustness 3 Developing program assessment criteria QUALITY RISK MANAGEMENT LIFECYCLE 9

10 INITIATE QUALITY RISK MANAGEMENT PROCESS Are complex risk assessment performed by a trained facilitator? Are risk assessments performed by a group or an individual? Departments represented Are the Risk Ques=on, Scope and Boundaries, Assump=ons defined? What is the ra=onal for the tool selected? When are the risk assessments ini=ated? Proac=ve, Reac=ve, Retrospec=ve RISK ASSESSMENT: RISK IDENTIFICATION Area hazards and harms are clearly described? What method(s) are used to iden8fy hazards and harms? Are reasonably expected hazards iden8fied? 10

11 RISK ASSESSMENT: RISK ANALYSIS What risk scales (i.e., risk ranking criteria) were used for the assessment? Are the scales: Objec?ve? Pragma?c? Simple? Are the criteria applied consistently? Do the criteria align with the objec?ve of the assessment? RISK ASSESSMENT: RISK EVALUATION Are the thresholds for risk evalua1on defined? Are all risks that exceed the risk threshold moved into risk control? 11

12 EXAMPLE THRESHOLD TABLES Risk Level Low Actions Required Risk is acceptable. Overall Risk Level Risk Priority Number Required Action/Acceptability of Residual Risk Medium High Risk may be acceptable. Mitigation may be required after addressing all Highs. Risk is not acceptable. Mitigation required. Consider the need for interim controls. High Mitigation required. Medium Mitigation required, unless appropriate justification is provided. Low 1 27 No further action required. RISK CONTROL Do risk control measures focus on preven3on or detec3on? Do mi3ga3ons address the root cause of the hazard? Does the report outline mul3ple risk control strategies as possibili3es with a ra3onale explaining the selec3on of the implemented plan? How are controls tracked? If a high risk is iden3fied with long term solu3ons planned, are interim controls iden3fied? Is a risk benefit analysis performed when high risks are not able to be mi3gated? 12

13 OUTPUTS: RISK REPORTS Are risk reports are numbered and tracked as individual living assessments or included with the investigation/deviation that trigged the assessment? Do risk reports include all elements identified in the initiation, assessment, control stages of the lifecycle? Are required risks are incorporated into the risk register? RISK REVIEW What types of risk assessments require review? What is the frequency of review? What triggers exist to invoke risk review if the defined period of ;me (i.e., one year) has not been be met? 13

14 RISK MANAGEMENT TOOL SELECTION Is the same tool is used for all assessments? Is the tool selected appropriate for the assessment needs? RISK COMMUNICATION Is there a mechanism to report risks at the site or other impacted sites? Are there defined forms of communica6on Is there a risk register? Are risk reports consistently documented and retrievable? 14

15 AGENDA 1 QRM Cultural Maturity: Outline three elements of a robust risk management program 2 QRM Technical Maturity: Risk Ac>vity Robustness 3 Developing program assessment criteria REFLECTION Re-evaluate the maturity model provided. Did your assessment change? What will you bring back your organiza>on? 15

16 Thank you Amanda McFarland Connect with me on Linkedin! 16