Appendix 1 — Registry of Key Risks and Opportunities
Parent procedure: 05 – Addressing Risks and Opportunities
Purpose
To maintain a comprehensive, living record of all risks and opportunities identified by the laboratory, their assessments, planned actions, implementation status, and outcomes. This registry serves as evidence that the laboratory systematically considers risks and opportunities per ISO/IEC 17025:2017, Clause 8.5.
Instructions
The Quality Manager maintains this registry. All identified risks and opportunities are entered, assessed, tracked, and reviewed for effectiveness. The registry is:
- Updated at minimum annually during quality management reviews
- Updated whenever risks/opportunities are identified (ongoing)
- Reviewed at each management review for progress and effectiveness
Registry of Risks and Opportunities
Section 1: Identified Risks and Opportunities
| ID | Type | Description | Area/Method | Identified by | Date | Likelihood | Impact | Priority | Status |
|---|---|---|---|---|---|---|---|---|---|
| [#] | Risk / Opportunity | [e.g., "ICP-OES instrument aging; risk of failure and downtime"] | [e.g., "ICP-OES elemental analysis"] | [Name] | [Date] | [High/Medium/Low] | [High/Medium/Low] | [Critical/High/Medium/Low] | [Identified/Assessed/Action planned/In progress/Completed/Closed] |
Section 2: Risk and Opportunity Assessment
For each risk/opportunity identified in Section 1, complete the assessment below:
| ID | Type | Assessment Date | Likelihood Rationale | Impact Rationale | Mitigation/Opportunity Value | Feasibility | Evaluator | Notes |
|---|---|---|---|---|---|---|---|---|
| [#] | Risk / Opportunity | [Date] | [e.g., "High - instrument is >10 years old; similar instruments in industry have failed"] | [e.g., "High - no backup ICP-OES; testing would stop for 2-4 weeks"] | [e.g., "Preventive maintenance would reduce risk to low likelihood"] | [High/Medium/Low] | [Name] | [Any additional context] |
Section 3: Action Planning
For each risk/opportunity assessed, document planned actions:
| ID | Type | Planned Action | Responsible Person | Target Completion Date | Budget/Resources Required | Success Criteria | Action Status |
|---|---|---|---|---|---|---|---|
| [#] | Risk / Opportunity | [e.g., "Schedule preventive maintenance every 6 months; establish backup calibration standards"] | [Name] | [Date] | [e.g., "€500/year maintenance contract"] | [e.g., "Maintenance log updated; performance verification passed each quarter"] | [Planned/In progress/Completed/Cancelled] |
Section 4: Implementation and Monitoring
Track the implementation and effectiveness of each action:
| ID | Action | Implementation Start Date | Completion Date | Completed By | Effectiveness Assessment | Outcome Notes | Follow-up Required? |
|---|---|---|---|---|---|---|---|
| [#] | [Maintenance schedule] | [Date] | [Date] | [Name] | [Worked as planned / Partially effective / Did not work] | [e.g., "First maintenance completed; instrument performance improved. Recommend continue quarterly schedule"] | Yes / No |
Section 5: Closed Risks and Opportunities
Document risks that have been fully mitigated or opportunities that have been completed/declined:
| ID | Description | Type | Closure Date | Outcome | Why Closed | Lessons Learned |
|---|---|---|---|---|---|---|
| [#] | [Risk/Opportunity description] | Risk / Opportunity | [Date] | [e.g., "Preventive maintenance implemented; risk reduced to low"] | [Mitigated / Accepted / Opportunity achieved / Not pursued] | [Any insights for future risk management] |
Summary and Trends
As of [Date]:
- Total Risks Identified: [#]
- Active Risks: [#] (Critical: [#] | High: [#] | Medium: [#] | Low: [#])
- Total Opportunities Identified: [#]
- Opportunities Pursued: [#] | Being monitored: [#] | Declined: [#]
- Closed/Mitigated: [#]
Recent Actions Completed:
- [Action 1 and outcome]
- [Action 2 and outcome]
Key Risks Requiring Attention:
- [List any critical or high-priority risks still in progress]
- [Include target completion dates]
Management Review Integration
This registry is reviewed periodically (at minimum annually) by laboratory management with attention to:
- Status of high-priority and critical risk actions
- Effectiveness of completed mitigation actions
- New risks or opportunities identified since last review
- Opportunities being pursued and their progress
- Trends in laboratory risk profile
- Resource adequacy for addressing identified risks
Some laboratories use color-coding (red/yellow/green) for risk status. Others integrate this registry with a risk matrix spreadsheet or risk management software. The key is maintaining objective evidence that risks and opportunities are being considered and acted upon. Keep the registry accessible to quality management team members but secure from unauthorized access.