The Quality Leader's Q4 Checklist
As we inch closer to the new year, competing priorities can make it easy to miss critical tasks. Here are a few to keep in mind.
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The last quarter of the year can be stressful for RA/QA teams. When teams crunch to get projects done on time, it’s easy to miss critical end-of-year activities that can threaten internal policy and external regulatory compliance.
The checklist below is by no means exhaustive. Rather, it’s a collection of routinely missed activities in Q4 based on the thousands of firms worked with via consulting and staff augmentation engagements.
If you need expert support with any of these tasks, don’t hesitate to contact us to discuss an engagement tailored exactly to what you need and when and where you need it. Be aware that consultants and contractors are in extremely high demand going into 2024. The sooner you engage us, the more likely we can provide the top talent you need.
1. General quality system management
Preparation for Management Review Meetings: Are Management Review Meetings scheduled and prepared for Q4 with a focus on quality metrics, trends, and improvement strategies?
Quality Metrics Trend Analysis: Have quality metrics been evaluated for trends that indicate systemic issues, and have actions been planned?
End-of-Year Resource Assessment: Have resources been assessed to ensure they are adequate for end-of-year activities, including personnel, equipment, and budget?
Training Compliance Verification: Has compliance with all required training been verified and documented before year-end?
Quality System Performance Review: Has the performance of the quality system been reviewed against established KPIs and objectives?
Document Control Audit Completion: Have all documents been audited for proper control and archival?
Internal Audit Schedule Adherence: Is the internal audit schedule confirmed to ensure all remaining planned audits are on track for completion?
2024 Audit Scheduling: Have you scheduled and resourced your audits and auditors for 2024?
Supplier Audit Prioritization: Are supplier audits reviewed and critical supplier audits prioritized for the end of this year and next?
Audit Findings Closure Tracking: Are all audit findings from earlier this year tracked and reviewed for closure or escalation?
Audit Preparation: Has preparation for next year’s audits begun by reviewing previous audit reports and corrective action plans?
Audit Action Item Follow-Up System: Is there a system in place for regular follow-ups on audit action items?
Inclusion of Cross-Functional Perspectives in Audits: Are cross-functional team members included in audits to provide different perspectives?
Current Status of Audit Tools and Checklists: Have audit tools and checklists been reviewed and updated to stay current with regulatory changes?
Auditor Resourcing: Have you resourced the audits you’re planning to conduct still this year and next? (If not, talk to us about auditor resourcing ASAP; top auditors are being booked well into 2024.)
3. CAPA program management
Progress Evaluation of Open CAPAs: Have all open CAPAs been evaluated for progress and ensured they are on track for timely closure?
CAPA Effectiveness Check Scheduling: Are effectiveness checks scheduled and conducted for CAPAs that have reached their due date?
Proactive CAPA Identification through Data Trending: Is data trending used to identify areas that may require CAPA before issues arise?
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