1) The document describes a design for improving the preventative maintenance program at Amgen to increase efficiency and effectiveness. 2) Key aspects of the new design include removing redundant or unnecessary tasks, optimizing task frequencies, adding new tasks based on failure history, and training operators to perform some tasks to reduce maintenance costs and downtime. 3) For the improvements to be sustainable, the updated preventative maintenance program needs to be fully implemented and continuous improvement processes established.

1. Design and Improvement of Amgen Preventive
Maintenance Program
Submitted to
Sponsor: Senior Engineer Carlos Umpierre
Amgen Manufacturing Limited
Juncos, Puerto Rico
RCM Team
August 10, 2015
by
Mechanical Engineering Co-op: Hector David Ortiz Melendez
Polytechnic University of Puerto Rico
San Juan, Puerto Rico

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Executive Summary – As part of the Reliability Centered Maintenance (RCM) Team in AMGEN I
assisted in the design of the Preventive Maintenances (PM). For this task I was expected to
improvement the preventive maintenance’s aiming to increase efficiency and effectiveness. Using
Lean Six Sigma and technical knowledge I was able to assist in the creation/editing and drafting of
more efficient and effective PMs. This PM design is intended to provide adequate equipment
performance, based on acceptable risk, while incurring the least amount of production impact and
utilizing minimum maintenance resources including labor, parts & materials, etc.
This PM design will result in a positive impact on both Maintenance & Production – the total
improvement will be additive. Impact on Maintenance: Reduced labor, parts utilization, contractor
costs, etc. resulting in…Maintenance cost reduction as well as Impact on Production: More time
available to run, fewer interruptions, less scheduled downtime, better equipment performance,
increased equipment reliability, consistent operation.

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Table of Content
Executive Summary...................................................................................................................................... 2
Problem Definition....................................................................................................................................... 4
Problem Scope
Technical Review
Design Description….……………………………………………………………………………………………………………………………5-7
Overview
Detailed Description
Use
Next Steps

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Problem Definition
Problem Scope – Preventive Maintenances (PM) with low efficiency and effectiveness. There are too
many good components being replaced, there is too much scheduled downtime, lack of standardized
documentation process, there is a high labor hour percentage in PMs, there are too many failures still
occurring and too much unscheduled downtime. Also, the PM’s are not developed using consistent
process, PMs are not identifying work early enough, and the planning & scheduling process is starved.
Technical Review – Reliability is the quality or state of being reliable or the extent to which an
experiment, test, or measuring procedure yields the same results on repeated trials. As defined on the
Merriam-Webster dictionary. In the biotechnology industry, disregarding it is considered an overhead to
the operation, it has proven to be very useful when it comes to reducing the waste of the organization
and providing a more efficient and effective operation through the correct maintenance for each
equipment just when the equipment requires it. The reliability of the equipment in the biotechnology
industry is an important addition to its culture. The needs for reliability are generally proven through the
increase of uptime and the effective and efficient implementation of PMs. For the successful satisfaction
of these needs, some technology and methods are at our disposal including, but not limited, to vibration
analysis, oil analysis, thermography, ultrasonic analysis, etc.

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Design Description
Overview – This improvement design increases PM effectiveness and PM efficiency, thus increasing the
total uptime of the equipment impacted by this initiative. It achieves this purpose by constantly
eliminating waste (See figure 1) (i.e. no value added maintenances, redundancy in maintenances, etc.)
from the equipment’s maintenances.
Detailed Description – Below is the complete design process.
1. Assessment Preparation
o Equipment Revision
o Assess the equipment to confirm that all are covered in PMs.
 Is equipment being maintained?
 Is the maintenance the correct one?
 Is the maintenance at the correct frequency?
 To determine correct frequency use:
o Equipment’s documented failure history
o Manufacturer’s recommendations
o Technical Expertise
o Equipment’s maintenance need vs availability to perform
the maintenance (i.e. equipment usage)
 Is the maintenance redundant?
 Is the equipment missing components in maintenance?
 Does the maintenance include components that the equipment does not
have?
2. Assessment Improvement
o Task Removal
o Perform task removal techniques
 Is task redundant? (keep most frequent task)
 Is task applicable to machine under review?
 Can task prevent or detect failure?
 Is task cost effective?
 Is task overkill on low critical equipment?
 Can the need for PM task be designed out?
o Document rationale for any task removal
o Improvement
o Establish all failure modes for components with existing PM tasks
o Establish all failure modes for components called out on any Generic PM tasks
o Perform improvement techniques by comparing network practices and external
reliability studies performed by the organization:
 Can task be promoted
 Can task be assigned to different skill or craft?

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 Can task be performed with equipment safely running?
 Can detailed task instructions improve execution?
 Can equipment modifications improve task time?
 Identify any equipment modifications required to perform
optimized tasks and generate a work order
 Can frequency of task be improved?
o Document rationale for optimized tasks
o Run Assignment Report to proofread all activities and modify accordingly
o Add Tasks to supplement PM
o Review failure history in CMMS (maximum of 2 years on single asset history or
history for corrective and emergency work orders across multiple same assets) and
Add/Amend PM. Add tasks on components that have existing defects without W/O
history based on observations made during initial walk down
o Evaluate remaining components (have no history of failure or existing PM tasks)
o Determine if Reliability Strategy is needed for components with no PM and no
History
 Interview with Mechanic to review list of open components and determine if
PM task is needed or Run-to-Fail strategy is acceptable
 Can the problem be detected
 What is the severity of the problem
 PM/No PM (Run-to-Fail)
 Interview with Mechanic of un-captured, informal PM tasks outside of PM
Work order
o Review OEM Manual
o Answer any questions from exercise
o Review recommended PM tasks and confirm they are addressed
o Adjust naming of Functions>Components accordingly
o TPM Task review
o Walk down each task with Operations to determine if task can be performed by
operator
 Ensure recommended modifications have been completed
 Train operators
o Follow up on open items, question to complete the PM data
o Export improved PM by frequency, equipment state (running / down), and craft into CMMS
o Local Site Implementation
o Update improved PM in CMMS following the job plan revision process

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Use – See Figure 1 for a clear picture of the process.
Figure 1
Next Steps – For the PM design to remain in force, it needs to achieve a sustainable status within the
client’s organization. Since the principal focus of the design is to increase reliability and uptime, it
requires to be implemented as part of the sites maintenance efforts. Also, maintenance’s action plan
continuous improvement needs to be considered as a best practice regarding the maintenance
activities. This improvement is designed to work properly only when a continuous and sustainable
process is achieved within the client’s organization.
NOTE: The recommendation is for the client to assume into its culture that reliability equals safety.
Consider reliability to be as important as safety.