Business Value Stream Map and Improvement Identification: Level 8 Biopharma Lean Sigma Assignment, Ireland

Title: Business Value Stream Map and Improvement Identification

Overview

You will identify a business that you are familiar with and develop a value stream map (VSM) of a specific product line for a life science related business.

You will two identify areas of non-value in the VSM outlining their reasons
why they are considered non-value. For both areas identified, they will use the DMAIC methodology to describe the problem, outline the current situation and identify potential improvements and sustaining activities.

Learners can make assumptions in this academic exercise on the root causes of the problems. Finally, you will summaries the value stream, issues and suggested solutions in a 5 minute video.

Notes:

1. The VSM must of a life science related business.
2. You can use some of the examples that are provided as templates and you can edit them for your VSM.
3. You can use estimates for data. You do not need to contact organisations and ask for data.
4. You cannot take an existing piece of work that your organisation has completed and present it as your own
work.
5. You can submit the assignment on Moodle as one document or multiple documents.

Background:

A major biotechnology and chemical synthesis company manufactures drug products on a commercial scale including monoclonal antibodies and small molecule medicines used to treat illnesses including cancer, diabetes and Alzheimer’s disease.

Choose scenario (a) OR (b)

• During cleaning validation of a monoclonal antibody drug product used in the treatment of treatment of type 2 diabetes, a visual inspection failure was noted post CIP of batch D5837A. White residue was noted on the sidewalls of a 2,100L bioreactor in the upstream manufacturing suite.
• Customer complaints reported incorrect labelling of tablets used for the treatment of lung cancer. One lot of 30mg extended-release tablets were incorrectly labelled as 60mg extended-release tablets.

Tasks:

Using scenario (a) or (b):

1. Prepare a risk question to address the risk scenario (5%)
2. Prepare a cause and effect/ fishbone diagram to investigate and identify as many potential failure modes
3. Perform a risk assessment using a FMEA chart

• Construct FMEA chart
• Using a RPN 1-5 scale, define the RPN ratings
• Assign the severity (S), occurrence (O) and detection (D) of 3 identified failure modes from fishbone diagram and calculate total RPN
• Explain the reason for the assigned RPN rating for each failure mode

4. What action items from the FMEA chart need to be taken to risk mitigate the problem

You work in QA at a finished product manufacturer of biotech and non-sterile products.  You are doing an internal audit and you are reviewing Preventative Maintenance (PM) activities.  You see reference to a Risk Assessment exercise that was performed on a set of Hydraulic Diaphragm Pumps at the site.

You ask for the background to this and you are told the following:

A product contamination issue occurred during the manufacture of a biotech product at a sister site.  This was the result of a Hydraulic Diaphragm pump failure at that site.

• The pump membrane dislodged from its housing during routine production
• Hydraulic oil migrated to the product side of the membrane
• The oil contaminated the batch

The site in Ireland learned of this issue and it carried out a risk assessment to determine the following:

• If the Irish site was using similar pumps – yes, many such pumps were in use, in the Fill Finish (FF) and in the Oral Dosage manufacturing areas of the plant (called OD1 and OD2).
• The risks of failure associated with such pumps
• The required risk-mitigating actions that should be taken

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