Risk Assessment for Relocation of Compression Machine
Relocating a tablet compression machine within a pharmaceutical facility is not a simple shifting activity – it is a GMP-critical change that can impact product quality, equipment performance, and compliance. A structured risk assessment is therefore essential before, during, and after relocation.
Objective of the Risk Assessment
- Identify potential risks linked to relocation (quality, safety, compliance, productivity)
- Evaluate impact on machine performance, tablet quality, and process validation
- Define controls, qualifications, and documentation needed to maintain a validated state
Key Risk Areas Considered
Using tools such as 6M / Ishikawa diagram, FMEA, or risk matrix, the assessment typically covers:
- Machine – damage during shifting, alignment issues, lubrication, wear, utility connections, control panel integrity
- Method – dismantling/installation procedure, leveling, calibration, changeover, cleaning and line clearance practices
- Material – potential for contamination or mix-up of in-process material or tooling
- Man (Personnel) – training gaps for operators, riggers, maintenance and validation teams
- Measurement – impact on in-process controls (weight, hardness, thickness, friability, metal detection) and their calibration
- Mother Environment – room classification, HVAC, temperature/humidity, differential pressure, dust extraction efficiency, noise
Control Measures & Qualification
Based on risk ranking, suitable controls are defined, such as:
- Detailed relocation and re-installation SOP
- Verification of utilities (power, compressed air, vacuum, dust extraction, dust collection)
- Re-IQ/OQ of the compression machine at the new location
- Challenge tests: weight variation, tooling fitment, safety interlocks, emergency stop, dust collection efficiency
- Partial or full process validation / performance qualification (PQ), if impact on product is significant
Documentation & Change Control
All activities must be executed under an approved Change Control, with:
- Risk assessment report
- Dismantling/installation checklist
- IQ/OQ/PQ reports
- Deviations and CAPA (if any)
This webpage section can guide QA, Production, and Engineering teams to treat compression machine relocation as a controlled, auditable GMP change, not merely a mechanical shifting job.