Question

Coursehero Describe how FMEA can be implemented in a bioproduction facility. What steps did Lonza take to prevent problems at its Portsmouth, NH facility?

Answer 1

FMEA can be implemented at a bioproduction facility following the list of 7 steps which includes different parameters to look for.

Lonza harnessed FMEA priciples earnestly to shift cell therapy works to its centre of excellence and thus utilise New Hampshire unit for clinical and manufacturing purpose.

Explanation:

FMEA or Failure Mode or Effects Analysis is a certified way to analyse and address any sort of problem or changes before the occurrence of the event itself. FMEA can be implemented very easily in the bioproduction facility using the following mentioned steps-

1. Need to select a process which is to be analysed.
2. Group the team facilitator and its members.
3. Provide a complete description of the process.
4. Identify all the potential zones of failures.
5. Sort the problem which is to be worked on.
6. Design and later implement appropriate changes to reduce the problems.
7. Quantify your changes and the success of the process.

Lonza’s facility at New Hampshire is one of the largest employment providers of the city. Recently the group was involved in specific problems such as sterility with cell therapy. Previously it had an FDA encounter too due to its biologic’s operation. Hence through FMEA, the group decided to allot its gene therapy work to its excellence centres elsewhere and New Hampshire would be involved in doing the works of clinical and manufacturing sites.