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

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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

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The objective of this project is to improve the accuracy of right

the first time comments in EBRs

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METHODS AND APPROACH

12

The DMAIC methodology was utilized to ensure proper process

management and effective results

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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

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15

The Pareto Chart analysis was used to identify the significant

problems in non-right the first time EBRs

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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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THANK YOU