Executive Summary Below is a practical 360-degree feedback questionnaire designed for the Pharma industry across BUL Drug Production, Quality Control (QC), Quality Assurance (QA), and for roles from Officer to Manager level. It is written to fit regulated environments by emphasizing: Quality & Compliance, GMP discipline, Data Integrity, Safety, teamwork, leadership, and continuous improvement.

Key Recommendations

• Use the same core questionnaire for all functions (BUL, QC, QA) to keep benchmarking consistent, but slightly tailor examples wording for Managers vs Officers.
• Keep ratings structured and behavior-based (avoid “what you think” questions).
• For regulated pharma, ensure “Data Integrity” and “Deviation/OOS/OOT handling” items are prominent.
• Use a 5-point rating scale + 2 open feedback prompts per section.

Rating Scale (use consistently) 1 = Strongly Disagree / Not demonstrated 2 = Disagree / Needs improvement 3 = Neutral / Sometimes demonstrated 4 = Agree / Consistently demonstrated 5 = Strongly Agree / Exemplary

Recommended 360 Stakeholder Roles

• Self
• Reporting Manager (line manager)
• Peers (same function or cross-functional: Production/QC/QA)
• Internal Customers (e.g., QC/QA stakeholders impacted by your work)
• Subordinates (only if the person has people reporting to them; otherwise exclude)
• Optionally: Cross-functional partners (Maintenance/Stores/Engineering) if relevant

Questionnaire (Officer/Non-Manager Version) Instructions for respondent: Rate the person based on behaviors observed in the last 6–12 months.

A) Quality, GMP & Compliance (Weight: High)

1. Demonstrates strong GMP discipline in daily activities.
2. Follows SOPs/WI and ensures work is performed “as written.”
3. Raises concerns promptly when GMP compliance risks are identified.
4. Ensures documentation is accurate, complete, and timely.
5. Maintains confidentiality and follows internal compliance rules.
6. Understands and applies applicable regulatory/compliance expectations in their domain.

B) Data Integrity (Weight: Very High for Pharma)

1. Ensures ALCOA+ integrity principles are followed in records, logs, and reports.
2. Does not falsify, backdate, overwrite improperly, or “complete later” without authorization.
3. Handles corrections appropriately (single-line strike-through, date/sign, reason per SOP).
4. Ensures audit trails are not disabled/overwritten without compliance authorization.
5. Maintains consistency between raw data and finalized reports/records.
6. Demonstrates clean handovers of data (e.g., from sampling to analysis to reporting).

C) Deviation, OOS/OOT, CAPA Mindset

1. Supports identification and proper classification of deviations.
2. Conducts/coordinates investigations with facts, root cause thinking, and evidence.
3. Ensures immediate actions are taken to protect product/process quality.
4. Writes/reviews CAPAs with clear actions, owners, timelines, and effectiveness checks.
5. Participates effectively in CAPA closure with evidence and validation where required.
6. Looks for trends and prevents recurrence rather than “closing paperwork.”

D) Technical Quality in QC/QA/BUL Production Context (Use as applicable; all can remain, but you may customize wording for each department)

1. Applies correct testing/inspection methods or production/processing controls.
2. Ensures correct sample identity, labeling, traceability, and handling.
3. Ensures appropriate calibration/qualification expectations are supported/maintained.
4. Reviews/re-checks critical parameters to prevent avoidable errors.
5. Uses checklists and verifications effectively.
6. Provides reliable technical inputs to cross-functional quality decisions.

E) Safety, Hygiene & Site Discipline

1. Follows EHS practices and PPE requirements.
2. Reports hazards, near misses, and unsafe conditions promptly.
3. Maintains cleanliness/5S/hygiene aligned with GMP expectations.
4. Uses equipment safely and reports faults/maintenance needs.
5. Supports a “stop-work” culture when critical safety or compliance risks occur.

F) Collaboration & Customer Focus (Internal Customers)

1. Responds to QC/QA/Production needs in a timely and professional manner.
2. Communicates clearly and avoids rework through complete information.
3. Works constructively across functions (Production/QC/QA/Stores/Maintenance).
4. Handles disagreement with respect and focuses on resolution.
5. Supports trainings/knowledge sharing with peers.

G) Accountability & Ownership

1. Meets defined timelines and quality expectations for their work.
2. Takes responsibility for errors and drives corrective actions.
3. Seeks clarification when requirements are ambiguous instead of guessing.
4. Uses risk thinking to prioritize work (quality risk first).
5. Shows reliability and follows through on commitments.

Open Comments (Officer Version)

1. What should the person continue doing?
2. What should the person improve in the next 3–6 months?
3. Provide one suggestion to strengthen quality performance or compliance.

Questionnaire (Manager Version) Instructions: Same rating scale. Add leadership and system-thinking items. Use these extra sections; keep A–G above but add H–J.

A–G (same as Officer) Plus:

H) Leadership & Compliance Ownership

1. Sets the tone for GMP and quality culture in the team.
2. Ensures adequate training, competency, and oversight to prevent quality failures.
3. Coaches team members to follow SOPs and data integrity expectations.
4. Makes risk-based decisions and escalates appropriately.
5. Ensures effective management of priorities without compromising quality.

I) Investigation, Decision-Making & Effectiveness

1. Reviews deviations/OOS/OOT/CAPA with strong evidence and root cause rigor.
2. Ensures CAPAs are not just “actions,” but effective prevention measures.
3. Tracks and ensures closure quality (verification/validation as applicable).
4. Promotes trend analysis and systemic improvements across processes.

J) Continuous Improvement & Change Control Leadership

1. Encourages a proactive approach to improvement and learning.
2. Manages change controls with proper impact assessment and approvals.
3. Drives standardization, simplification, and reduction of repeat issues.
4. Supports audits/inspections readiness through disciplined preparation.

Open Comments (Manager Version)

1. What are the top behaviors that strengthen team quality performance?
2. Where should leadership focus to improve compliance/quality outcomes?
3. Suggest one systemic improvement initiative for the next cycle.

Scoring & Reporting (Simple and Usable)

• For each section (A–G and A–J), compute:
• Average rating (1–5)
• “Low scores” count (ratings 1–2)
• Provide weighted scoring (recommended):
• Data Integrity: 25%
• Quality/GMP/Compliance: 25%
• Deviation/OOS/OOT/CAPA mindset: 20%
• Technical quality: 10%
• Collaboration & accountability: 10%
• Safety/EHS: 10%
• (For Managers only) Leadership/Investigation/CI add: adjust weights proportionally (e.g., leadership total 20–30%)

Suggested Weighting Example for Officers

• A Quality/GMP/Compliance (25%)
• B Data Integrity (25%)
• C Deviation/OOS/CAPA (20%)
• D Technical Quality (10%)
• E Safety (10%)
• F Collaboration & Customer Focus (5%)
• G Accountability (5%)

Suggested Weighting Example for Managers

• Same A–G weights but increase:
• H Leadership (15%)
• I Investigation/Effectiveness (10%)
• J CI/Change Control (10%)
• Reduce D/F/G slightly to keep total = 100%

Immediate Next Steps (Implementation Plan)

1. Finalize roles:

• Create two versions: “Officer/Non-Manager” and “Manager”

1. Define 360 population:

• Include QC, QA, BUL Production roles as per grade/level

1. Select raters per person:

• Manager: 1
• Peers: 3–5
• Cross-functional internal customers: 1–3 (Production/QC/QA stakeholders)
• Subordinates: only where applicable (2–5)

1. Pilot for 2–3 weeks:

• 10–15 people across departments
• Validate item clarity, relevance, and time required

1. Train raters:

• Explain data integrity and compliance behavior focus

1. Set governance:

• Ensure confidentiality and escalation route for serious compliance concerns

To tailor it precisely, confirm just these 3 points:

1. Which countries/region are you operating in (for wording alignment, especially regulatory expectations)?
2. Do you want the questionnaire in English only, or bilingual?
3. Will you run it as an online form (e.g., Excel/Google/Microsoft) or paper-based?

If you need help implementing these recommendations or would like expert guidance tailored to your organization, the team at Zunavish would be happy to assist.