Microsoft Word - ex 11 & 12.docxPage 1 of 1 Exercise 12 Consider the following situation. Make use of FMEA to evaluate the risk to the patients and the company. (20) Your...

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Perform a Failure Mode andEffects Analysis (FMEA) risk assessment to determine the risks :





Does a small number of potential low fill or empty capsules in a single batch of Eplic®capsules pose an unacceptable risk to (i) patients, and (ii) to the company?





Microsoft Word - ex 11 & 12.docx Page 1 of 1 Exercise 12 Consider the following situation. Make use of FMEA to evaluate the risk to the patients and the company. (20) Your company manufactures Eplic® capsules. Eplic ® is used for the treatment and control of epilepsy. The capsule is an orange opaque capsule which contains 80 mg of active and should be taken twice daily with meals to control and prevent epileptic fits. Multiple customer complaints of empty capsules were received. Lot A12B was fully distributed in South Africa and no product remains within company control. There is no evidence of tampering. Upon review of the batch record it was found that a loose dosator pin was replaced on the encapsulation machine. Following replacement and prior to resuming encapsulation, acceptance testing of capsules produced required by Standard Operating Procedure was performed and product met requirements. Further investigation revealed that the loose dosator caused empty capsules to be produced. The encapsulation system utilized a vacuum system to remove empty capsules. This empty capsule removal system includes a reservoir for holding empty capsules rejected during the manufacturing process. As a result of the loose dosator, an atypically high number of reject empty/low fill capsules were produced during the encapsulation operation, causing the reservoir to be filled and eventually overflow. The reservoir was physically located over the acceptable capsule flow. Therefore, it was determined during the investigation that if the empty capsule chamber overflowed, there was potential for rejected capsules fall back into the acceptable capsule exit chute and be reintroduced to the lot. Sealed bottles were obtained from retained samples of the lot. Of 310 capsules examined, 31 empty and 3 low fill weight capsules were found. Between one and three empty capsules were found in 15% of the bottles which were evaluated. Risk Question: Does a small number of potential low fill or empty capsules in a single batch of Eplic® capsules pose an unacceptable risk to (i) patients, and (ii) to the company? Perform a Failure Mode and Effects Analysis (FMEA) risk assessment to determine the risks
Answered Same DayMar 20, 2023

Answer To: Microsoft Word - ex 11 & 12.docxPage 1 of 1 Exercise 12 Consider the following...

Dr. Saloni answered on Mar 21 2023
33 Votes
FMEA
FMEA is a systematic approach to identifying and evaluating potential failures and their conse
quences, determining the risk of the failure occurring, and prioritizing actions to reduce or eliminate the risk. In this case, we will use FMEA to assess the risk to patients and the company due to the production of empty and low-fill capsules in lot A12B of Eplic® capsules.
Step 1: Identify Potential Failures
Potential failures in this case include:
1. Production of empty capsules
2. Production of low-fill weight capsules
3. Failure of the empty capsule removal system to remove all empty capsules
4. Overflow of the empty capsule reservoir
5. Reintroduction of rejected capsules into the lot
Step 2: Assess the Severity
The severity of each potential failure is assessed on a scale of 1 to 10, with 10 being the most severe.
1. Production of empty capsules - 8
2. Production of low-fill weight capsules - 6
3. Failure of the empty capsule removal...
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