Standard Operating Procedure (SOP)
Clause 6.2 – Quality Objectives and Planning to Achieve Them
ISO 9001:2015
Document No.: QMS/SOP/009
Version: 01
Effective Date: __________
Review Date: __________
Approved By: Head – Quality / Site Head
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1. Purpose
To establish, implement, monitor, and review measurable Quality Objectives and define plans to achieve them in accordance with ISO 9001:2015 Clause 6.2, ensuring alignment with the Quality Policy, strategic direction, and continual improvement of the Quality Management System (QMS).
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2. Scope
This procedure applies to all departments involved in the manufacture, testing, storage, release, and distribution of Active Pharmaceutical Ingredients (APIs).
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3. Definitions
Quality Objective:
A measurable quality target established to achieve the commitments of the Quality Policy.
KPI (Key Performance Indicator):
A measurable value used to monitor progress toward achieving a quality objective.
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4. Procedure
4.1 Establishing Quality Objectives
Top Management, with Department Heads, shall establish Quality Objectives that are:
- Consistent with the Quality Policy.
- Relevant to applicable functions and levels.
- Measurable wherever practical.
- Monitored and communicated.
- Updated when necessary.
- Support customer satisfaction and continual improvement.
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4.2 Planning to Achieve Quality Objectives
For each Quality Objective, the organization shall define:
- Objective
- Target
- KPI
- Responsible Department
- Required Resources
- Action Plan
- Completion Timeline
- Monitoring Frequency
- Evaluation Method
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4.3 Sample Quality Objectives
Objective| Target| KPI| Responsible
Reduce customer complaints| ≤ 2 per quarter| Complaint trend| QA
Reduce batch rejection| ≤ 1% annually| Batch rejection rate| Production
Complete CAPAs on time| ≥ 95%| CAPA closure rate| QA
Complete internal audits| 100% as scheduled| Audit completion| QA
Complete employee training| 100%| Training compliance| HR / QA
On-time batch release| ≥ 98%| Batch release performance| QA/QC
Supplier performance| ≥ 95% approved suppliers| Supplier scorecard| Procurement
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4.4 Monitoring
Department Heads shall review Quality Objectives monthly or quarterly, as applicable, by:
- Reviewing KPI trends.
- Comparing actual performance against targets.
- Investigating gaps.
- Initiating corrective actions where targets are not achieved.
Progress shall be reported during Management Review meetings.
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4.5 Review and Revision
Quality Objectives shall be reviewed:
- During Management Review.
- When business strategy changes.
- Following significant regulatory changes.
- After major customer complaints.
- After significant audit findings.
- When continual improvement opportunities are identified.
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5. Responsibilities
Top Management
- Approve Quality Objectives.
- Ensure alignment with strategic direction.
- Provide required resources.
- Review performance during Management Review.
Head – Quality Assurance
- Coordinate establishment and monitoring of Quality Objectives.
- Consolidate KPI reports.
- Recommend improvement actions.
Department Heads
- Develop departmental objectives.
- Monitor KPIs.
- Implement action plans.
- Report performance.
Employees
- Support achievement of departmental objectives.
- Follow approved procedures.
- Participate in improvement initiatives.
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6. Documented Information
Maintained Documents
- Quality Objectives Register
- KPI Monitoring Plan
- Departmental Improvement Plans
Retained Records
- KPI Reports
- Trend Analysis Reports
- Management Review Minutes
- CAPA Records
- Performance Dashboards
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7. References
- ISO 9001:2015 – Clause 6.2
- Quality Policy
- Management Review Procedure
- CAPA Procedure
- Risk Management Procedure
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Auditor Expectations
Auditors typically verify that:
- Quality Objectives are established and documented.
- Objectives align with the Quality Policy.
- Objectives are measurable and monitored.
- Responsibilities for achieving objectives are assigned.
- Resources and action plans are defined.
- Progress is reviewed and actions are taken when targets are not met.
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Typical Auditor Questions
1. What are your organization's Quality Objectives?
2. How are Quality Objectives established?
3. How do departmental objectives support the Quality Policy?
4. Which KPIs do you monitor?
5. How often are Quality Objectives reviewed?
6. What happens if a Quality Objective is not achieved?
7. Can you show evidence of monitoring and trend analysis?
8. How are employees made aware of Quality Objectives?
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Expected Employee Response
"My department has defined Quality Objectives that support the organization's Quality Policy. We monitor our KPIs regularly, review our performance against targets, investigate any shortfalls, implement corrective actions when necessary, and report progress during departmental reviews and Management Review meetings."
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