Pharmaceutical Risk Assessment FMEA for Sampling activity to be carried out in dispensing booth is very crucial in pharmaceutical industries. As both activities are different. Sampling is very initial step for the quarantined material. Dispensing is the initial phase before startup of manufacturing.
What is Pharmaceutical Risk Assessment FMEA ?
Pharmaceutical Risk Assessment using Failure Mode and Effects Analysis (FMEA) is a approach used to identify, evaluate, control and mitigate potential risks that may affect product quality, patient safety. It helps to determine possible failure modes in a process, assess their severity, likelihood of occurrence, and detectability, and prioritize risks using the Risk Priority Number (RPN).
Importance of Pharmaceutical Risk Assessment –Sampling Activity in a Dispensing Booth
Risk Assessment using Failure Mode and Effects Analysis (FMEA) is essential for sampling activities performed in a pharmaceutical dispensing booth because it helps identify and control potential risks before they affect product quality. Sampling is a critical GMP activity, and even a small error can lead to contamination, mix-ups, incorrect test results, batch rejection, or regulatory non-compliance.
Power Failure Risk Assessment in Manufacturing
Objective of Risk Assessment -Sampling Activity in Dispensing Booth
The objective of conducting a Pharmaceutical Risk Assessment FMEA for sampling activity to be carried out in dispensing booth is to identify, evaluate, control and mitigate potential risks associated with the sampling process that could impact product quality, patient safety, and GMP compliance. The assessment helps identify possible failure modes, determine their severity, likelihood of occurrence, and detectability, calculate the Risk Priority Number (RPN), and implement appropriate risk control measures to minimize contamination, material mix-ups, labeling errors, documentation issues, and environmental risks.
Risk rating criteria
| FMEA: Risk rating factors | Risk Rating |
| Impact on People and Environment | – |
| 1. 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 |
| 2. 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 |
| 3. 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 |
Risk Priority Number (RPN) & Risk Evaluation Matrix
The Risk Score (Risk Priority Number) shall be used to define risk ranking as follows:
| RISK EVALUATION | RPN | RISK | LEVEL | |
| 1 TO 30 | LOW | 1 | Actions not required however the continuous monitoring and review is recommended | |
| 31 TO 75 | MEDIUM | 2 | Actions for the correction and Preventive required | |
| 76 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. |
Examples for Pharmaceutical Risk Assessment FMEA Sampling activity carried out in dispensing booth
Process Steps Entry of material into dispensing booth
Failure mode Wrong material brought for sampling
Failure Effect Material mix-up, incorrect testing and release decision
Probable Causes Inadequate or incorrect Labeling
operator error, Inadequate verification
Initial Measures Labeling SOP is in place
Material verification is in place before initiating sampling procedure.
Process Steps Dispensing Booth Verification
Failure mode Dispensing booth not cleaned before sampling
Failure Effect Cross-contamination of sample
Probable Causes Inadequate cleaning, cleaning SOP not followed.
Initial Measures Cleaning SOP is in place.
Cleaning checklist is available.
Type A, Type B cleaning is clearly specified.
Training programme is already in place.
Cleaning record verification is already in place
Process Steps Gowning Procedure
Failure mode Improper gowning practices
Failure Effect Product contamination from personnel
Probable Causes Lack of training, non-compliance with gowning procedure
Initial Measures Gowning SOP is already in place.
Pictorial for easy understanding of gowning is already in place.
Training programme is already in place.
Process Steps Sampling tool Cleanability
Failure mode Unclean or incorrect sampling accessories used
Failure Effect Sample contamination
Probable Causes Poor cleaning of sampling accessories
Initial Measures Dedicated tools are used for the API and excipients.
Cleaning of sampling tools after every sampling is already in place
Process Steps Material Exposure
Failure mode Excessive exposure of material to environment
Failure Effect Contamination of material and sample.
Probable Causes Prolonged opening, improper handling technique
Initial Measures Only one container is opened at the time of sampling.
Dedicated AHU with HEPA filtration caters the Dispensing area.
Environment monitoring is already in place.
Process Steps Labeling
Failure mode Cross-contamination between materials.
Incorrect or missing sample label.
Failure Effect Product quality impact and possible batch rejection.
Sample misidentification
Probable Causes Multiple materials handled simultaneously, poor cleaning practices
Initial Measures Handling of one material at a time.
Cleaning of booth between the activities is already in place.
Labeling procedure is already in place.
Process Steps Sample Transportation
Failure mode Sample damaged or lost during transfer
Failure Effect Delay in analysis and possible re-sampling
Probable Causes Improper handling, inadequate packaging
Initial Measures Sample transferred to QC with proper handling and Labeling.
Sample container is already in use for the storage and transportation of samples. controlled sample transfer procedure is already in place.
Process Steps Documentation
Failure mode Sampling details not recorded accurately
Failure Effect Traceability issues and GMP non-compliance
Probable Causes Documentation error, incomplete entries
Initial Measures GDP SOP is already in place.
Logbooks are available for recording the sampling and dispensing activities.
Process Steps Container closure
Failure mode Container not resealed properly after sampling
Failure Effect Material contamination, moisture ingress, deterioration
Probable Causes Person oversight, damaged closure system
Initial Measures Visual inspection is in place at the time of the receipt and handling of material.
SOP for handling and receiving of material is already in place.
Process Steps Material Storage
Failure mode Material not stored in designated area
Failure Effect Traceability issue.
Mix up between Quarantined, Under Test and approved material
Probable Causes Improper storage
Person oversightness
Lack of area
Initial Measures Labeling procedure for Quarantine, Under Test and approved are in place.
Training programme is already in place.
Sufficient/segregated area is provided for storage.
Process Steps Environmental control
Failure mode HEPA filter or airflow failure during sampling
Environmental conditions not within limits
Failure Effect Increased contamination risk.
Potential impact on sample quality
Probable Causes HVAC malfunction, inadequate maintenance and monitoring
Initial Measures Dedicated AHU with HEPA filter is already in place.
DP gauges are available for area to avoid the cross contamination.
Scheduled preventive maintenance for AHU and equipments are already in place.
Periodic HVAC validation is already in place.
SOP for EM monitoring is already in place.
Process Steps Sampling and analysis
Failure mode cross contamination
Failure Effect Product failure,
Contamination &
OOS/OOT
Probable Causes Product cross contamination
Initial Measures SOP for receipt and storage or received material is in place.
Material details (name/ batch no./ no. of containers/ vendor source) is verified against the purchase order and invoice during material receiving and is recorded in the material receipt checklist. Training is already provided to all concerned personnel for the SOP.
If material is not matching with the purchase order and invoice it is rejected.
SOP to control the contamination is available
SOP for preparation and approval of specification is in place. Approved specification for material and product is available. Sampling is performed from all received containers for API and √N + 1 for Excipient.
SOP to handle OOS and OOT is in place. Any product found with valid OOS is rejected, while product with OOT is investigated to identify the root cause. Investigation is carried out to identify the root cause and appropriate CAPA is implemented.
Process Steps Sampling and analysis
Failure mode Specification not prepared
Failure Effect Wrong analysis
False result reporting
Inadequate sampling
Probable Causes Sampling not perform properly
Initial Measures SOP for preparation and approval of specification is in place. Specification and STP is prepared as per the SOP through reference of approved pharmacopoeia.
Specification and STP for material and product is prepared and approved. Sampling is performed.
SOP for item code generation for new material is in place. During item code creation as per SOP, material specification and Pharmacopoeial status is also mentioned with the material.
Process Steps Sampling and analysis
Failure mode Sample quantity not available
Failure Effect Wrong analysis
False result reporting
Inadequate sampling
Probable Causes Sampling not performed as per SOP
Initial Measures SOP for preparation and approval of specification is in place.
Specification and STP is prepared as per the SOP through reference of approved pharmacopoeia or compendia.
Specification and STP for material and product is prepared and approved.
Sample quantity is mentioned in the specification.
Sampling is performed from all received containers as per SOP for API and √N + 1 for Excipient.
During item code creation the material specification and Pharmacopoeial status is also mentioned with the material for better traceability.
Process Steps Product analysis and release
Failure mode Specification not prepared
Failure Effect Wrong analysis
False result reporting
Probable Causes Product release without analysis
Initial Measures SOP for preparation and approval of specification is in place. Specification and STP is prepared as per the SOP through reference of approved pharmacopoeia or compendia. Specification and STP for material and product is prepared and approved.
SOP to handle OOS and OOT is in place. Any product found with valid OOS is rejected, while product with OOT is investigated to identify the root cause. Investigation is carried out to identify the root cause and appropriate CAPA is implemented.
Trained and qualified analysts are available in QC.
SOP for product release is available. Product is released for dispatch only if product is complying with the approved specification. Any product identified with valid OOS is rejected. Trained personnel are available to prepare the product specification.
| RISK INDEX MATRIX | |||||
| OCCURANCE/ PROBABILITY | |||||
| 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 |
| 1 | 2 | 3 | 4 | 5 | |
| DETECTABILITY | |||||