EXECUTIVE SUMMARY
Implementing a Curriculum for Improving Accuracy of Real-time Comments in
Electronic Batch Records for Genentech, Inc.
Author: Kirstie Hunt
Date: April 20, 2017
Professional Science Masters of Biotechnology Degree Program
California State University, San Marcos
Genentech is a biopharmaceutical company located in Oceanside, CA. The Oceanside campus
is one of five locations within the United States and is a multi-product drug substance
Manufacturing facility of biopharmaceuticals. The Manufacturing production plant is
controlled by an automated system called DeltaV, which facilitates the processing equipment
to effectively produce biopharmaceuticals. DeltaV has the ability to track any process
recordable including: alarms, holds/restart, overrides, and process interventions;
simultaneously recording them to an Electronic Batch Record (EBR). In addition to the
automated control system, Manufacturing bioprocess technicians provide manual support and
oversight for the process operations and equipment. There are a multitude of Standard
Operating Procedures (SOP), work instructions, training modules, instructor-led courses and
other tools that provide guidelines and information for employees to perform compliant
operations.
EBRs are official Good Manufacturing Practice (GMP) documents that provide an audit trail
for all manufacturing processes. The EBR is segmented into different sections including:
material usage, equipment usage, batch formula, procedure details, phase details, failure
messages, alarms, and process interventions. The EBR is generated real-time while a process
recipe is running in DeltaV and populates the information to the Manufacturing Execution
System (MES) or Syncade.
Completed EBRs are compiled into the MES queue and undergo Manufacturing Quality
Assurance (MQA) review, Manufacturing review, MQA approval and then become archived
once the process is complete. Each step within the review process is tedious and time
consuming, requiring acquisition of relevant information and a high degree of patience and
technical accuracy to ensure the job is done correctly. It is the responsibility of MQA to make
note of any issues, inconsistencies, or missing components within the completed record. It is
the responsibility of the Manufacturing Department to address MQA’s instructions with an
appropriate comment. This review process is prolonged if comments are not entered real-
time, thus generating more time in the review process and extensive investigation.
There are a number of EBRs that require rework, which adds complexity, time, and non-value
to the operations, thus costing Genentech money by impacting lot disposition and ultimately
patients receipt of medication in a timely manner. Genentech would like to codify a solution
for technicians to compose right the first time comments that are written real-time and reduce
the percentage of batch records that are not completed correctly. This project aims to
successfully analyze and implement a resourceful solution to the issue at hand.
The DMAIC approach was conducted in order to identify and analyze the contributing
elements that pose a threat to right the first time batch records. The DMAIC model is
comprised of the following components: Define, Measure, Analyze, Improve and Control.
The DMAIC approach is highlighted as a core component to the Six Sigma methodology,
which is widely used as an industry standard. Six Sigma is a disciplined methodology for
eliminating defects in Genentech’s manufacturing process. The utilization of this concept has
allowed for a development and implementation of an instructor-led training curriculum titled
Right the First Time Comments Training.
The idea of incorporating an instructor-led training course stemmed from studies stating it
was a more effective and engaging method of encoding the content to trainees. Reportedly,
70% of learning comes from on the job practice (Heathfield, 2016), thus guiding the
instructor-led training course to incorporate a variety of real life simulations that engage the
attention of the trainees. The objective of the training course is to teach technicians how to
write batch comments that are right the first time in order to avoid mistakes that may cause
unnecessary re-work and delays. Upon completion of this course technicians will be equipped
to navigate through MES/Syncade and DeltaV, locate in-process batch records, utilize process
historian, identify SOP linkages, and properly write a comment.
IMPLEMENTING A CURRICULUM FOR IMPROVING ACCURACY OF REAL-TIME COMMENTS IN ELECTRONIC
BATCH RECORDS FOR GENENTECH
Kirstie Hunt 10 May 2017
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Table of Contents
Introduction
• Manufacturing Model
• EBR Requirement
• EBR Review Process
Methods and Approach
• DMAIC Methodology
• Analytical Tools: The 5 Why’s and Pareto Chart
• The Learning Pyramid
Conclusion
• Project Implementation
2
INTRODUCTION
Genentech is a multiproduct
drug substance
manufacturing facility of
biopharmaceuticals located in
Oceanside, CA
4
5
Genentech incorporates an effective model for bioprocess
manufacturing operations
5
6
EBRs are permanent and controlled documents that must
follow Good Documentation Practices (GDP)
6
7
Comments ensure process exceptions are accurately
addressed with rationale and SOP acceptability
7
8
The flawless execution of the EBR review process leads to a
patient receiving medication in a timely manner
8
9
The gap in the EBR review process stems from the interchange
review process between MQA and Manufacturing Department
9
The objective of this project is to improve the accuracy of right
the first time comments in EBRs
10
METHODS AND APPROACH
12
The DMAIC methodology was utilized to ensure proper process
management and effective results
12
13
The Fish Bone Diagram was used to determine cause and effect
relationship
13
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The 5 Why’s analysis method was used to determine the rootcause of non-right the first time comments
14
15
The Pareto Chart analysis was used to identify the significant
problems in non-right the first time EBRs
15
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90% of individuals remember information if action learning is
executed over visual and verbal learning
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CONCLUSION
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The objective of the project is to address the knowledge gaps in
right first time comments
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The project provided bioprocess technicians with valuable tools and resources to effectively demonstrate control of the process
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“The course was interactive andthe instructors were enthusiastic about teaching the content.”
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The curriculum is currently being revised to incorporate
constructive feedback and align content with current practices
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Doing now what patients need next
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Citations
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Bonacorsi,S.(n.d.).ParetoCharts.RetrievedFebruary09,2017,fromhttps://www.projectsmart.co.uk/pareto-charts.php
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THANK YOU
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