Power Failure Risk Assessment in Pharmaceutical Manufacturing is one of the critical risks as it can disrupt production, affect product quality, and impact patient safety. There are many tools for Risk assessment but Failure Mode and Effects Analysis (FMEA) is a systematic risk assessment tool used to identify potential failures caused by power outages, evaluate their impact, and implement preventive measures. Applying FMEA helps pharmaceutical manufacturers maintain product quality, ensure regulatory compliance, and minimize operational disruptions.
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Power Failure Risk Assessment in Pharmaceutical Manufacturing
Power interruption can significantly impact the manufacturing by affecting the product quality, equipment performance, environmental conditions, and data integrity.
Importance of power failure risk assessment
Power failure risk assessment in pharmaceutical manufacturing is to identify and control the potential risks associated with unexpected electrical outages. A sudden loss of power can disrupt critical systems such as HVAC, purified water systems, manufacturing equipment, environmental monitoring and computerized systems, potentially affecting product quality, patient safety, and regulatory compliance.
By conducting a systematic risk assessment, pharmaceutical companies can evaluate the impact of power failures on critical operations, implement appropriate mitigation measures such as UPS and generator backup systems, and establish effective emergency response procedures
Objectives of Performing an FMEA Risk Assessment
Main objective of FMEA risk assessment is to identify the risk, to analyse the risk and to control the risk by giving the mitigation plan.
Scope of Power Failure Risk Assessment
Power failure risk assessment can help the industries to proactively analyze the risk associated in any stage of manufacturing or to give the proper mitigation plan.
Risk Rating Criteria (Severity, Occurrence & Detection)
Risk rating criteria are as follows
| 1. Rate the likelihood of prior detection for each cause of failure (i.e., the likelihood of detecting the problem before it reaches the end user or customer) as follows- | Risk Rating |
| 1 – Always detected (High degree of detectability) | 1 |
| 2 – Likely to detect (Good detectability) | 2 |
| 3 – Possible to detect (Likely to detect) | 3 |
| 4 – Unlikely to detect (Fair detectability) | 4 |
| 5 – Never detected (Low or no detectability) | 5 |
| FMEA: Risk rating factors | Risk Rating |
| Impact on People and Environment | |
| 21. Rate the severity of each effect of failure as follows – | |
| 1 – Insignificant/ Negligible (The Risk is so small that the team can ignore it.) | 1 |
| 2 – Minor/ Limited temporary impact (The Risk is insignificant and can be managed with routine procedures.) | 2 |
| 3 – Major/ Indirect reversible Impact (The Risk is significant but manageable with additional controls or mitigations.) | 3 |
| 4 – Critical/ Direct permanent impact (The Risk is severe and requires immediate attention and action.) | 4 |
| 5 – Catastrophic/ Life threatening or fatal (The Risk is intense and needs to be addressed) | 5 |
| 3. Rate the likelihood of occurrence (Probability) for each cause of failure as follows | Risk rating |
| 1 – Very rare/ Remote (So unlikely, it can be assumed an occurrence may not be experienced.) | 1 |
| 2 – Unlikely/ Low (Unlikely but possible to occur) | 2 |
| 3 – Possibly/ Moderate/ Medium (Likely to occur sometime) | 3 |
| 4 – Likely/ High (Will occur several times) | 4 |
| 5 – Almost certain (every time)/ Very likely (Likely to occur often ) | 5 |
Risk Priority Number (RPN) and Risk Evaluation Matrix – Power Failure Risk Assessment
The Risk Score (Risk Priority Number) shall be used to define risk ranking as follows:
| RISK EVALUATION | RPN | RISK | LEVEL | |
| 1 TO 40 | LOW | 1 | Actions not required however the continuous monitoring and review is recommended | |
| 41 TO 80 | MEDIUM | 2 | Actions for the correction and Preventive required | |
| 81 TO 125 | HIGH | 3 | Immediate mitigation is essential (over all correction is required) since the risk is very high and can have potential impacts on the quality of the products. |
Recommended Corrective and Preventive Actions (CAPA)
If the RPN number is between 1 to 40 then the risk level is low and there is no need of any additional Corrective and preventive action
If the RPN number is between 41 to 80 then the risk level is medium it means the monitoring is required.
If the RPN number is between 81 to 125 then the risk level is High and immediate mitigation plan shall be required.
Power Failure Risk Assessment in Pharmaceutical Manufacturing – Examples across Pharmaceutical Operations
Process Steps: Raw material & Packing Material
Failure mode: Lightning Failure in Receiving Area
Failure Effect: Power outage affects internal/external lighting, increased risk of physical damage or incorrect material handling.
Probable Causes: Poor visibility during unloading/inspection. Generator is not available in plant. Delay in light backup.
Initial Measures: Emergency lights are available in each area. Diesel Generator in factory is already in place. Power supply resumes within 5 minutes during power failure.
| Severity | Probability | Detection | RPN | Risk Level |
| 5 | 4 | 1 | 20 | LOW |
Failure mode: Environmental Monitoring System fails– Power Failure Risk Assessment
Failure Effect: Leads to contamination of product.
Probable Causes: AHU power failure
Initial Measures: Diesel Generator in factory is already in place. HVAC system is already linked with DG. HVAC recovery study is already done and in place.
| Severity | Probability | Detection | RPN | Risk Level |
| 5 | 3 | 2 | 30 | LOW |
Process Steps: HVAC System Failure- Power Failure Risk Assessment
Failure mode: Differential Pressure Failure / airflow stops
Failure Effect: Cross-contamination from uncontrolled area
Probable Causes: HVAC shutdown from power loss
Initial Measures: HVAC controls are already linked to DG set during power failure.
| Severity | Probability | Detection | RPN | Risk Level |
| 5 | 4 | 1 | 20 | LOW |
Failure mode: Container left open during outage
Failure Effect: Contamination, material degradation
Probable Causes: Mid-process halt, HVAC off
Initial Measures: Handling of equipment breakdown and utility failure in production area is already in place. All containers covered during power failure.
| Severity | Probability | Detection | RPN | Risk Level |
| 5 | 3 | 2 | 30 | LOW |
Equipment Failure
Process Steps: RMG failure
Failure mode: RMG stops mid-process
Failure Effect: Incomplete granule formation, batch rejection
Probable Causes: Power failure
Initial Measures: SOP for RMG is already in place. Microbial testing is in place. Handling of equipment breakdown and utility failure in production area is already in place. Diesel Generator is already in place.
| Severity | Probability | Detection | RPN | Risk Level |
| 5 | 4 | 1 | 20 | LOW |
Process Steps: FBD failure
Failure mode: Loss of heating/airflow
Failure Effect: Incomplete drying leads to microbial risk, Instability to the product
Probable Causes: Power cut to fluid bed dryer
Initial Measures: Inlet temp sensor in FBD is already in place. Microbial testing is in place. Generator connection to dryers is already in place.
| Severity | Probability | Detection | RPN | Risk Level |
| 5 | 3 | 1 | 15 | LOW |
Process Steps: Tablet compression Operation failure
Failure mode: Compression stops mid-run
Failure Effect: Weight variation, hardness inconsistency
Probable Causes: Power loss, compression motor shutdown
Initial Measures: Diesel Generator in factory is already in place.
During Operation or machine run, operator remains in the area.
Frequency of in-process for production and IPQA is in alternate hours.
| Severity | Probability | Detection | RPN | Risk Level |
| 5 | 4 | 1 | 20 | LOW |
Process Steps: Compression Control
Failure mode: Hydraulic pressure
Failure Effect: Over-/under-compressed tablets, Incosistent hardness & thickness.
Probable Causes: Machine Shutdown
Initial Measures: Diesel Generator in factory is already in place.
During Operation or machine run, operator remains in the area.
Frequency of in-process
| Severity | Probability | Detection | RPN | Risk Level |
| 5 | 5 | 1 | 25 | LOW |
Process Steps: Metal Detector Shutdown
Failure mode: Tablet bypasses metal detection
Failure Effect: Presence of Metal particles leads to product contamination
Probable Causes: Metal detector failure.
Initial Measures: Diesel Generator in factory is already in place.
Metal detector challenge test in every start and stoppage of machine is already in place.
| Severity | Probability | Detection | RPN | Risk Level |
| 5 | 3 | 2 | 30 | LOW |
Process Steps: De-duster Failure
Failure mode: Tablets not cleaned
Failure Effect: Excess powder on tablets, risk in coating
Probable Causes: De-duster stops
Initial Measures: Visual inspection procedure is in place.
Handling of equipment breakdown and utility failure in production area is already in place.
| Severity | Probability | Detection | RPN | Risk Level |
| 5 | 5 | 1 | 25 | LOW |
Process Steps: Punch Damage
Failure mode: Compression stops due to under load
Failure Effect: Punches get stuck or break
Probable Causes: Sudden power cut
Initial Measures: Diesel Generator in factory is already in place.
Handling of equipment breakdown and utility failure in production area is already in place.
Preventive maintenance schedule is already in place for machine.
Punch inspection is already in place before and after operation.
| Severity | Probability | Detection | RPN | Risk Level |
| 5 | 2 | 2 | 20 | LOW |
Process Steps: Coating Operation failure- Power Failure Risk Assessment
Failure mode: Coating pan motor stops in mid-batch
Failure Effect: Uneven coating, incomplete coverage, batch reject
Probable Causes: Power failure
Initial Measures: Visual inspection procedure of tablets is already in place.
Handling of equipment breakdown and utility failure in production area is already in place.
Coating machine is operated with UPS.
Process Steps: Blister Machine Operation failure
Failure mode: Machine stops mid-run
Failure Effect: Misaligned blisters, rejections
Probable Causes: Power failure to packing machine motor
Initial Measures: Handling of equipment breakdown and utility failure in production area is already in place.
Diesel Generator in factory is already in place and linked to the machine. Power supply resumes within 5 minutes during power failure.
During Operation or machine run, operator remains in the area.
| Severity | Probability | Detection | RPN | Risk Level |
| 5 | 4 | 1 | 20 | LOW |
Process Steps: Sealing/knurling Failure
Failure mode: Incomplete/altered sealing of foil
Failure Effect: Poor sealing leads to moisture to product which leads to degradation
Probable Causes: Heater plates cool during outage
Initial Measures: During Operation or machine run, operator remains in the area.
Frequency of in-process.
| Severity | Probability | Detection | RPN | Risk Level |
| 5 | 2 | 2 | 20 | LOW |
Process Steps: Stability Chamber Operation failure
Failure mode: Chamber temperature excursion
Failure Effect: Stability data invalidated
Probable Causes: Power to chamber lost
Initial Measures: 24/7 temp monitoring with alarms is already in place
| Severity | Probability | Detection | RPN | Risk Level |
| 5 | 4 | 1 | 20 | LOW |
Process Steps: Balance Operation failure
Failure mode: Balance powered off during weighing
Failure Effect: Incomplete or inaccurate weights
Probable Causes: Power loss
Initial Measures: Balances are linked with UPS.
Balance monthly calibration and daily verification is already in place.
| Severity | Probability | Detection | RPN | Risk Level |
| 5 | 4 | 1 | 20 | LOW |
Process Steps: Environmental Control failure – Power Failure Risk Assessment
Failure mode: HVAC failure in granulation area
Failure Effect: Temp/humidity excursion leads to granule variability
Probable Causes: No power to AHU
Initial Measures: Diesel Generator in factory is already in place. HVAC system is already linked with DG.
| Severity | Probability | Detection | RPN | Risk Level |
| 5 | 2 | 2 | 20 | LOW |
Process Steps: Documentation/Batch Records incompletion
Failure mode: Incomplete recording of coating parameters
Failure Effect: GMP non-compliance, batch traceability issue
Probable Causes: System/PC power failure
Initial Measures: Emergency lighting is already in place.
Diesel Generator in factory is already in place. Power supply resumes within few minutes during power failure.
| Severity | Probability | Detection | RPN | Risk Level |
| 5 | 4 | 1 | 20 | LOW |
Process Steps: Material Handling Interruption/failure
Failure mode: Coating materials exposed or mixed up
Failure Effect: Contamination, batch rejection
Probable Causes: Process halted abruptly
Initial Measures: Material labeling SOP is in place. Handling of equipment breakdown and utility failure in production area is already in place
| Severity | Probability | Detection | RPN | Risk Level |
| 5 | 3 | 2 | 30 | LOW |
Process Steps: Material Segregation failure
Failure mode: Lighting failure in quarantine storage
Failure Effect: Material misidentification
Probable Causes: Power failure to lights
Initial Measures: Emergency lighting is already in place.
Diesel Generator in factory is already in place.
Material labeling SOP is in place
| Severity | Probability | Detection | RPN | Risk Level |
| 5 | 4 | 1 | 20 | LOW |
Process Steps: Material storage failure
Failure mode: Temperature & RH failure in quarantine
Failure Effect: Product degradation
Probable Causes: Power failure to HVAC
Initial Measures: Environment monitoring is in place.
Diesel Generator in factory is already in place.
HVAC system is already linked with DG.
HVAC recovery study is already done and in place.
| Severity | Probability | Detection | RPN | Risk Level |
| 5 | 3 | 2 | 30 | LOW |
RISK INDEX MATRIX
| OCCURANCE/ PROBABILITY | |||||
| Rating | 1 | 2 | 3 | 4 | 5 |
| SEVERITY | |||||
| 1 | 1 | 4 | 9 | 16 | 25 |
| 2 | 2 | 8 | 18 | 32 | 50 |
| 3 | 3 | 12 | 27 | 48 | 75 |
| 4 | 4 | 16 | 36 | 64 | 100 |
| 5 | 5 | 20 | 45 | 80 | 125 |
| Rating | 1 | 2 | 3 | 4 | 5 |
References:
ICH Q9 (R1): Quality Risk Management
EudraLex Volume 4 – EU Guidelines for Good Manufacturing Practice, Part I, Chapters 1, 3, and 5.