Annual ASQ San Diego Quality Conference

Transcription

1 Annual ASQ San Diego Quality Conference Discovering the Tools of Quality and Culture Change Utilizing Audit and CAPA to Drive Cultural Evolutions in an Organization Presented by Marie Graves- November 4 th, 2017

2 Introduction- About the Speaker Specialties Audit CAPA Supplier Management Risk Training Marie Graves, CQA, RAC, MS-BQS QA Compliance professional 12 years of experience in regulated medical devices Quality Manager at NuVasive Previous: pfm medical Inc., ImThera Medical, and Gen-Probe (Hologic)

3 What makes a good CAPA program Risk based monitoring of QMS Triggers for CAPA Escalation The 4 T s Simple templates & training for investigators Structured CAPA communication Effective Trending Communicating costs in practical ways

4 Risk based monitoring of QMS Single risk scale utilized whenever possible- ISO Inputs to risk should vary to accommodate each process. Product risks should always be aligned with product design files- living documents. Frequency should include a scale of occurrence easily tied to PPM defects or cost.

5 Risk based monitoring of QMS C o m p l a i n t s N C M R s C A P A Reportable events, Design Changes, Major process changes, Projects with large resource demands Product, label or Process deviations & supplier deviations Product Monitoring for Safety & Efficacy

6 Triggers for CAPA Escalation The same Complaints happening above the established thresholds. New Complaints for failures you didn t expect that have a large risk. The same Nonconformances happening above established thresholds. New Nonconformances that have a large risk (aka product has been released and can cause a high risk failure). Audit findings always trigger CAPA.

7 HIGH RISK MEDIUM RISK LOW RISK Triggers for CAPA Escalation Frequency is high OR Severity is high Or both Business needs to devote resources to prevent more Costs Frequency is medium to high Severity is medium Business should start allocating resources to prevent Costs Frequency is low to medium Severity is Low Business should monitor for similar trends in these issue to stop potential Costs from occurring

8 So you have a CAPA You need 4T s Templates or Technology- Simple CAPA forms for documenting investigations & actions Training- Reoccurring training for investigators, weekly, monthly, as much as you need to be effective. Talking- Structured CAPA review Board meetings Trending Assign costs to deficiencies

9 CAPA Take home Create A CAPA & Audit system you can use to Change the Culture 1) A strong foundation for QMS- risk scale that is cross functionally aligned. 2) A defined risk based CAPA escalation mechanism. 3) Templates/Technology, Training, Talking, Trending. 4) Demonstrate effective outcomes of CAPA investments. Through audit

10 What makes a good Audit program Standard & regulation based checklists Utilizing internal knowledge Maintaining trust & building communication Education programs for audit Management Trending & audit schedules based on risk Creating links to CAPA

11 Audit Checklists Define the scope- keep it basic You can create one checklist for regulations and standards that covers the entire QMS Define CAPAs to be verified as effective Define minimum time periods for assessment Define the minimum sampling of records

12 Utilizing Internal Knowledge for Audits Create a schedule that requires audit teams to have a subject matter expert Define goals for auditor qualification in other departments Create easy auditor toolkits Hold regular trainings on the internal audit process

13 Trust & Communication A good auditor is a good listener Audit is an opportunity for the auditee to showcase their hard work Let the auditee ask questions Communicate issues as you see them Remember, you are teaching the audit process

14 Trending - Audit schedules based on CAPA Risk

15 Using CAPA & Audit to Build a case for Change Get cross functional input & document all inefficiencies related to CAPA causes Assigning cost to inefficiencies Research & leverage technology Have a SOLUTION Create an ROI for implementation Present the data, let it speak for itself

16 Probability & Detection 4 Moderate Minor Minor Negligible 3 Moderate Moderate Minor Minor 2 Undesirable Moderate Moderate Minor 1 Undesirable Undesirable Moderate Moderate Priority Level Assignment Overall Risk Matrix Assignment 1 Unacceptable (May warrant field action) Severity Guidelines for (S) & (P / D) Risk Matrix Ratings Severity Serious injury (reversible or irreversible), death, intervention required to prevent permanent impairment. Probability & Detection Very high probability, Over 10% occurrence rate. No detection methods in place for failure until occurrence. CAPA Escalation Risk Scale 2 Moderate Moderate injury to the patient or user or moderate negative effect on the surgical procedure. Longer treatment time or new minor treatment required. 3 Minor Minor injury to the patient or user or minor negative effect on the process. Decline of product performance or user confidence in the product. 4 Negligible No injury to the patient, user, or surgical procedure. Possible little damage to the device. No CAPA needed. Moderate probability, less than 10% occurrence rate.. Detectable in the field during use only prior to failure. Low probability, less than 5% occurrence rate. Detectable by inspection prior to shipment to the end user / customer. Very low probability, less than 1% occurrence rate. Detectable with current process controls. No CAPA needed.

17 Risk Based CAPA timelines Task Type CAR PAR Priority Level Due Date (within) Investigation X X 1 15 Days 2 30 Days 3 30 Days 4 30 Days Correction X N/A 1 15 Days 2 30 Days 3 45 Days 4 60 Days Corrective Action X N/A 1 30 Days Preventive Action Assessment Verification of Effectiveness 2 30 Days 3 45 Days 4 60 Days X X 1 45 Days 2 60 Days 3 75 Days 4 90 Days X X 1, 2, 3, 4 As deemed appropriate by QA

18 CAPA Investigation Template

19 CAPA Trending

20 CAPA Trending

21 Design controls (7.3) Training (6.2.2) Non-conforming product (820.90) Internal Audits (8.2.2) Calibration (7.6) Identification (7.5.3) Supplier controls (7.4.2) Production/process controls (820.70) Order Fulfillment (7.2.2) Control of documents (4.2.3) Medical Device Reporting (Part 803) CAPA ( ) Corrections/Removals (806) Servicing ( ) Internal and External Audit Findings 2017 Internal External Cumulative Total 6 100% 5 90% 80% % 60% 3 50% % 30% 20% 10% % Confirm the data: Audit Trending

22 Cost Assessment of Current Inefficiencies $5, $7, $11, $23, $42, $59, $18, $14, $16, CAPA Trending linked to internal Costs $5, $4, No Metric Dashboards (Manual reports) Manual uploads to/from other systems (duplicate work) Limited or no visibility to docs for other departments Manual record retention x Limited or X no search functionality No Inbox for user tasks No auto links to other systems Manual data pushing to other system Local saving required for documents Technical issues daily / weekly (IT Support) No automatic notifications for users

23 $ TOTAL Assessment Score Comparative System Capability Assessments of eqms 120% 100% 80% 60% 40% 20% 0% System Robustness System Scalability System Integration QCBD 100% 84% 74% 123 Complaince 91% 84% 79% MASTERCONTROL 91% 95% 95% VEEVA VAULT 91% 95% 100% CAPA leading to Technology Solutions *approximate values based on 2017 data $1,800,000 $1,600,000 $1,400,000 $1,200,000 $1,000,000 $800,000 $600,000 $400,000 $200,000 $0 Comparative Total Costs for eqms System Cost Up-front System Cost Annually QCBD $373,600 $181, Complaince $537,520 $618,148 MASTERCONTROL $831,491 $167,802 VEEVA VAULT $1,618,000 $1,268,000

24 Return on Investment

25 Making a Case

26 Making a Case

27 Final Wrap up A personal story of Quality transformation building a Cross- Functional Culture of Quality

28 Annual ASQ San Diego Quality Conference Discovering the Tools of Quality and Culture Change Utilizing Audit and CAPA to Drive Cultural Evolutions in an Organization Q & A