pharmaceutical/foods capability brochure
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For Regulated Industrial Operations
Let us help you achieve a Quick Response to the problems facing your
company!
Introducing Quick Response……
The unique consulting approach that will change your company forever!
Let us help you achieve world-class compliance, quality, and
manufacturing excellence!
C. H. Paul Consulting, Inc. 7370 Ventnor Drive
Tobyhanna, PA 19466 570-216-4571
www.chpaulconsultinginc.com
Copyright © 2013 C. H. Paul Consulting, Inc., Tobyhanna, PA - All Rights Reserved 2
C. H. Paul Consulting, Inc.
C. H. Paul Consulting, Inc.
t C. H. Paul Consulting, Inc. we provide our regulated
clients (pharmaceutical, medical devices, consumer
products, cosmetics, foods, etc.) with a wide range of consulting
interventions designed to improve the efficiency and effectiveness
of their workers in technology-driven regulated work
environments, meet world-class compliance requirements, and
achieve manufacturing excellence!
We have been serving our corporate clients for over 25 years with
a practice dedicated to dramatically affecting client performance
and profitability through improved competence.
The Challenge
usiness has changed radically over the last 20 years. The
emergence of new technologies, intense competition,
shortage of trained workers, and heightened regulatory scrutiny has
created an environment where companies must respond quickly to
the problems facing them with a measured response that minimizes
risk and maximizes results. Our answer to helping you meet these
challenges is our Quick Response approach.
Quick Response is not a product but a methodology for delivering
consulting services that quickly address the “real” problems
holding you back from achieving your goals.
A Quick Response solution will help you to:
A
B
OUR QUICK RESPONSE
SERVICES AND
SOLUTIONS
PLANT FLOOR TRAINING &
NEW PLANT START-UP SUPPORT – Job training for
operators, mechanics
technicians, and first-line
supervisors.
DOCUMENTATION AND
TRAINING – Training and
documentation solutions that focus exactly on the skills and
knowledge needed to do the job.
COMPLIANCE SUPPORT FOR REGULATED
INDUSTRIES – SOP/GMP
evaluation, development, and
training.
ENTERPRISE SYSTEM
PERFORMANCE SUPPORT –
Preparing workers to perform their jobs using integrated
enterprise-wide software
systems.
PERFORMANCE
MANUFACTURING – Lean
Manufacturing Consulting
Services for our industrial clients.
TRAINING CAPABILITY
BUILDING – Helping our clients to build training
capability within their
organizations.
MANAGEMENT/LEADERSHIP
DEVELOPMENT – Helping
managers to meet the leadership challenges of the new century.
Quickly identify where performance discrepancies exist.
Quickly build project teams to address those discrepancies.
Formulate and implement approaches to the problems
identified.
Transform the company into a learning organization that is
armed with the knowledge to achieve excellence.
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C. H. Paul Consulting, Inc.
Regulation Issues
here are five key regulatory issues concerning personnel,
training, and task performance that must be carefully
addressed in order to be in compliance.
These issues include:
Failing to address any or all of these points opens a significant
window of vulnerability for any regulated operation.
Our Quick Response process is designed to meet and address each
of these issues.
T
Requirements that all personnel must be “trained in the
particular operations the employee performs and in current
good manufacturing practice (CFR regulations and the written
procedures required by the CFR regulations)” in order to be
qualified to perform those job.
Implied requirements that there be a system in place that
documents training performed by employees on an “on-going”
basis.
Requirements that written procedures be prepared in the form
of SOPs. Requirements that all tasks performed for which SOPs exist be
performed in accordance with those SOPs.
Implied requirements that SOPs be specific and complete fully
describing the tasks to be performed to include all metrics, tools,
cleaning materials, replacement parts, etc.
SOPS REQUIRED AS A
MINIMUM
Cleaning and maintenance of
equipment including utensils
Calibration of automatic,
mechanical, and/or electronic
equipment
Production and process
control
Identifying strength, quality,
and purity of products
In-process controls, tests or examinations of batch
samples
Preventing objectionable microorganisms from
entering products not
required to be sterile
Preventing contamination of
sterile products
Prescribing a system for reprocessing batches
Receipt, identification,
storage, handling, sampling, examination, and/or testing of
labeling and packaging
material
Warehousing of products
Distribution of drug products
Calibration of instruments,
apparatus, gauges, and
recording devices
Sampling and testing
Stability testing program
Testing sterile or pyrogen-
free drug products
Testing controlled-release drug products
Evaluation of drug products
Preparation of master
production and control
records
Training
Compliance is not a paper exercise designed
to meet the requirements of regulatory
agencies. Rather, it establishes the rules of
work and guarantees the efficacy of the
products produced for the consuming public!
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C. H. Paul Consulting, Inc.
Regulatory Scrutiny is Real
n a search of past warning letters it is clear that the FDA is
placing particular emphasis on the five key regulatory issues.
Requirements that all personnel be trained:
“Failure to ensure that all personnel are trained to adequately perform
their assigned responsibilities and to document the training, as required by
21 CFR 820.25 (b). For example:
The QA Technician was releasing finished goods into finished goods
inventory without documented training or authorization. The only
personnel authorized to release finished devices into finished goods
inventory are the Directors of QA and Regulatory Affairs (RA), and the
Supervisors of QA and RA.”
Implied requirements that there be a system in place that
documents training and that training be on-going:
“The QA Inspector responsible for testing and acceptance activities does
not have any documented training prior to xx/xx/xxxx although the
inspector has been employed since xxxx.”
Requirements that procedures be prepared as SOPs:
“Failure to establish and maintain procedures to prevent contamination of
equipment or product by substances that could reasonably be expected to
have an adverse effect on product quality 21 CFR 820.70 (e) in that there is
no SOP describing the proper technique to be employed for handling
stoppers used for lyophilized products during weighing procedures.
Stoppers used for lyophilized products were observed being weighed in an
open warehouse on a dirty cart; the operator weighing the stoppers was
observed handling the stoppers with bare hands. Stoppers are not washed
prior to use.”
Requirements that all tasks must be performed in accordance
with SOPs:
“During the manufacture of Pulmozyme bulk lot #XXXXX, manufacturing
personnel reduced the agitation rate from the specified ________ after the
bulk began to foam. No justification was provided for choosing the
alternate mixing speed or explanation of why foaming occurred.”
I
FIVE REGULATORY
ISSUES
All personnel must be trained
in the particular operations
the employee performs and in
current Good Manufacturing Practice.
System must be in place that
documents on-going
employee training.
Written SOPs must be
prepared that address all facets of operations.
SOPs must be specific and
completely describe the tasks
to be performed.
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C. H. Paul Consulting, Inc.
SOPs must be specific and complete:
“The SOP entitled “QA Release Department Review of Batch Production
Records and Test Results” is inadequate in that it allows manufacturing
supervisors to make changes to batch records without the knowledge or
consultation of the manufacturing employees that were involved in the
discrepancies.”
“SOPs do not describe the requirements for mixing of the sample of
absorbed Pertussis Toxoid intermediates, bulk product, or final filled
container prior to removing an aliquot for pH testing. Percent
adsorption, thimerosal, and aluminum testing is also performed on the
aliquot, for which lack of mixing could affect the test results”
“Media fill procedures do not describe required activities in response to
a failure.”
“SOP 21T69 does not specify a holding time limit for a sample prior to
testing.”
Achieving Compliance & Operations Excellence
here are four basic areas other than chemistry and biology
that contribute to compliance failures within any regulated
operation.
Training – When workers do not know what to do or how to do it,
they cannot be expected to perform tasks in compliance with SOPs
and applicable regulations. “Training” for the industry in general
is varied ranging from having employees read SOPs on a frequent
basis as “training” to the conduct of an actual formal training
process that includes a combination of classroom and “hands-on”
job practice, and formal knowledge and skill testing supported by
comprehensive reference documentation. The small group within
the industry that suffers the misconception that reading SOPs is
training, place their organizations at great risk from a compliance,
safety and environmental standpoint.
Documentation (SOP’s) – The work instructions prepared in the
form of SOPs that form the rules of work in any regulated
organization should be built to serve three basic functions – as
training documents, as on-the-job reference documents, and to
satisfy compliance requirements. As a training document, SOPs
form the basis of instruction focusing on those skills and
knowledge that are critical to the performance of the job. As on-
the-job reference documents, SOPs eliminate the requirement that the trainee remember multi-step complex tasks and ensure
T
COMPLIANCE FAILURES
TRAINING
Workers don’t know what to
do.
Training is poor.
Training is infrequent.
Training is not relevant to specific job tasks and
procedures.
There are no objective standards for determining
competence.
Training conducted is not documented.
DOCUMENTATION
Documentation not
sufficiently detailed.
Documentation not maintained.
Documentation not readily
accessible.
Documentation punishing to
use.
Tasks not performed
according to documentation.
ACCOUNTABILITY
No consequences associated
with non-performance.
SUPERVISION
Supervisors/managers do not
enforce compliant performance.
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C. H. Paul Consulting, Inc.
performance to 100% of the specified standard in terms of the
sequence of events, tools, parts, and materials used,
administrative/reporting requirements, the safety precautions that
must be taken, and any environmental considerations. As
compliance documents SOPs should be sufficiently detailed so that
an individual with minimal training would be able to perform the
task using the document as a reference. Previously, there was a
school of thought in the pharmaceutical industry that generalizing
the content of SOP’s would provide manufactures with sufficient
latitude to explain discrepancies when questioned by FDA or other
regulatory inspectors. This is no longer the case. A review of
warning letters will show time after time the attention and
importance attached to this documentation and the level of scrutiny
that they attract.
Accountability – All of the training and documentation in the
world will not ensure compliance. There must be consequences
associated with non-performance or incorrect performance.
Personnel must be held accountable when they short-cut or ignore
regulated procedures, work methods, or other specified job
requirements. Without accountability there can be no “comfort-
level” as to the work performed and if that work is in compliance
with all SOPs and regulations.
Supervision – Supervision must never ignore or avoid their
responsibilities in terms of work performance. Supervision must
be knowledgeable of the SOPs that dictate how the work within
their area of responsibility must be performed, demand full
compliance to those SOPs, monitor how work is performed, and
administer counseling and discipline when deviations occur.
In order to be cost effective, develop your compliance
documents once!!! Documentation should meet
regulatory requirements, should support technical job
training, and should be available as user-support job
tools!
WELL-DESIGNED AND
DEVELOPED
COMPLIANCE
DOCUMENTATION
Documentation is sufficiently
detailed so that a novice
performer can follow the
listed instructions and perform the task perfectly.
Documentation is highly
illustrated to eliminate confusion and enhance utility.
Documentation is produced
as a minimum to address each task and operation as
specified by regulations.
Documentation designed to support technical job
training.
Documentation is easily maintained.
Documentation forms the
basis of a comprehensive performance improvement
process.
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C. H. Paul Consulting, Inc.
Achieve Results With Quick Response!
oday, competitive advantage can be lost in the blink of an
eye and changes in the global economy can place your
business at risk virtually every day at market close. Companies
that are not ready to respond quickly, that do not have the support
systems in place, and have not harnessed the collective power of
the workforce… will fail!
If you have asked yourself these questions, you need Quick
Response:
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Do we have the standardized systems in place to support
performance at all levels of the organization?
Have we built a learning organization to achieve long-term
competitive advantage?
Do we have the tools to gather, maintain, and process the
knowledge of our company?
Is our corporate behavior aligned with our strategic goals and
our vision?
Do we consistently measure and manage performance?
Does our corporate culture inspire personal and professional
growth, loyalty, dedication, and trust?
OUR PHILOSOPHY!
We believe that our client’s primary business objectives must
address:
PROFIT MAXIMIZATION
AND GROWTH – now and
into the future!
PROFITABILITY, EFFICIENCY, AND
EFFECTIVENESS – increase
only as a result of engineering,
improving, measuring, and managing work performance!
JOB ABILITY – in the form of
skills and knowledge, is
acquired through on-going
training, performance support, and work experience!
WILLINGNESS TO WORK --
is maintained, enhanced, and
strengthened by satisfying the
worker’s economic, psychological, and social
needs and by building an
organization based upon
mutual trust, fairness, and basic human dignity!
EXCELLENT
PERFORMANCE –
organizational, individual, and
group – can be structured, improved, and sustained by
applying a systems engineering
approach to the design,
execution, and management of work!
Our mission is to provide our clients with the
means to solve their own problems, to become
totally self-sufficient, and to maximize the
utilization of their most critical resources
……people, systems, and processes……
Copyright © 2013 C. H. Paul Consulting, Inc., Tobyhanna, PA - All Rights Reserved 8
C. H. Paul Consulting, Inc.
Where Our Services Apply
he techniques we utilize to implement change and improve
performance apply to a great many areas of critical work.
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WHERE OUR SERVICES
APPLY
Manufacturing
Training and Human
Resources
Marketing
General and Administrative
Manufacturing Quality, Maintenance, Manufacturing Operations, Production, Planning,
Warehouse, and Inventory Control
Training and Human Resources Instructional Systems/Curriculum Development, Training Materials
Development, and Trainer Training
Marketing Field Sales & Service, Sales Management, Installation, Repair, Order
Handling, Customer Service, and Distribution
General & Administrative
Information Technology, Customer Service, Credit & Collections, Clerical
Office, Financial Office, and Personnel
The key to effective learning is in the process employed to
develop, present, and assess training. Effective training
must be:
……performance based, job relevant, and include only
the information needed to perform the tasks to be
mastered……
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C. H. Paul Consulting, Inc.
The Quick Response Approach
Planning
Prior to beginning any Quick Response implementation, it
is vital that we explore your group’s purpose, vision,
strategy, and objectives to insure complete linkage and
understand of your corporate environment and regulatory
challenges facing your associates. This step enables us to
formulate a program that directly and completely meets
your needs.
Analysis
A critical analysis of the issues under investigation is next
conducted. The very last thing that anyone needs from a
consulting intervention is an approach that does not apply,
is inappropriate in structure for the problem identified,
does not meet the organization’s diversity of needs, cannot
be easily implemented, does not facilitate growth and
improvement, and does not achieve measurable
quantifiable results.
Approach Design
The development of a detailed Approach Design is as
fundamental to any consulting initiative as it is to the
building of a bridge or a high-rise building. The Approach
Design specifies the actions, requirements, interactions,
and results of each project phase.
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C. H. Paul Consulting, Inc.
Process Development
During this step, the project structure for change is created
and the building blocks are set in place. Our staff works in
partnership with your associates to create the project
materials, activities, actions, and strategies that meet the
project requirements specified during the Approach Design
Phase.
Training and Implementation
Training is one of the vehicles used to implement the
results of any Quick Response project. Training is tailored
to meet the particular needs of each audience. The
universal complaint about most training is that it lacks
long-term effectiveness. In far too many cases, participants
simply forget what they learned and lapse into old ways.
This is because the content is not job relevant, does not
support organizational goals and objectives, is not
supported by middle and senior management, and is not a
component of the performance management system. This
does not happen with Quick Response!
Reinforcement and Systems Support
Based on your needs and environment, we will provide a
range of follow-up services, including performance
assessments and studies, one-on-one coaching, focus group
activities, and refresher training.
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C. H. Paul Consulting, Inc.
Our Clients
ur clients are represented by many of the largest Fortune 1000 companies in the
United States.
Imclone Systems Medco, Inc. Shared Medical Systems
Johnson & Johnson Site
Microsurgical
Johnson & Johnson Cordis Johnson & Johnson Personal
Products Company
Sanofi-Aventis Sanofi-Pasteur Frito-Lay
Johnson & Johnson Iolab Norwich-Eaton Pharmaceuticals SmithKline Animal Health
Block Drug Clairol, Inc. Pepsi Cola
Johnson & Johnson Janssen
Pharmaceutica
SmithKline Pharmaceuticals Johnson & Johnson Ortho
Pharmaceuticals
Bristol-Myers Products Pfizer Pharmaceuticals Nitta Casings
McCormick & Company Church & Dwight Ciba Geigy Pharmaceuticals
Nabisco Foods Bristol-Myers Convatec Pilot Chemical – Fine Chemicals
The Great Atlantic & Pacific
Tea Company
Johnson & Johnson Site
Microsurgical
Bristol-Myers U. S.
Pharmaceutical Group
Beiersdorf, Inc. Merck & Company Novartis Pharmaceuticals
Lederle Laboratories American Cyanamid Quaker Oats
Schien Pharmaceuticals Solvay Pharmaceuticals Miles Laboratories
Alpharma (Purepac) Nabisco Biscuit Nice Pak
Johnson & Johnson Consumer
Products -- Liquids
Johnson & Johnson Baby
Products Company
Johnson & Johnson Consumer
Products – Wound Care
McNeil Consumer Healthcare Pfizer Animal Health Colgate
Hills Pet Foods Aventis Dendreon
Sandoz Johnson & Johnson Ortho-
Clinical Diagnostics
Johnson & Johnson Neutrogena
O
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C. H. Paul Consulting, Inc.
Plant Floor Training
orkers will excel only when they are comfortable in doing
the work assigned and they have a reasonable expectation
of success. The key to achieving this functioning state is job
competency!
We have been developing plant floor training for over 25 years!
Our process has stood the test of time and has only been enhanced
by the application of new learning and documentation
technologies.
We are dedicated to providing workers with the tools and training
they need to be successful on the job and companies with the
results they need to minimize costs, improve product quality,
improve customer service, and maximize production effectiveness.
Generic manufacturing technology training does not produce the
transference of skills to actual situations that is critical to sustained
efficient plant operations. To be effective, plant floor training must
be specific and custom-designed to the workers' jobs and the
equipment and processes they operate. Our training minimizes
training times by only training those skills that are required to
perform each task successfully.
Our experience developing this type of training for industry is vast.
All of our plant training solutions are developed on a team basis
with client representatives and are designed and implemented to be
presented and maintained by in-plant personnel to ensure self-
sufficiency and ownership.
Most importantly, the technical training component is a
Certification Training Approach. This means workers are
performance tested and certified as able to perform learned
tasks...BEFORE...being released to the production environment.
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PLANT FLOOR TRAINING
Our performance-based plant floor training includes:
JOB ANALYSIS AND DESIGN –Used to develop staffing plans
that assure efficient team
operations and serve as the basis
for job training and skill-based pay system implementation.
CURRICULUM DEVELOPMENT – Custom-
designed technical training
curriculums developed to
support performance-based incentive systems, lean
manufacturing staffing
strategies, training delivery
constraints and requirements, and job enhancement and
enrichment requirements.
PERFORMANCE SUPPORT
TOOLS – Job aids to support
the performance of critical
tasks – electronic or paper-based.
TRAINING TOOLS –Instructor tools to streamline the learning
process and guarantee
mastery.
TRAINING DELIVERY
SUPPORT – Development of
strategies to maximize the effectiveness of training
delivery across the workforce.
IMPLEMENTATION
SUPPORT – Training of
corporate assets to administer
and maintain the training system produced.
CERTIFICATION – Development of performance-
based certification instruments
that measure “actual” after-training performance.
The most important people in the organization are the operators,
mechanics, and technicians that tend the production process
……everyone else in the company exists to support their efforts……
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C. H. Paul Consulting, Inc.
Documentation Services
ffective documentation is the key to creating a learning
organization. Without it, there is no basis for improvement,
no basis for “lessons learned,” and no basis for solving current
problems.
The technical documentation that we produce is user-friendly
meets ISO, regulatory, and other documentation requirements and
can easily be used for both instructional and performance support.
Training Services
s a full service performance consulting firm, we are able to
design curriculum and prepare training materials to meet a
variety of training needs for many job categories and functional
areas.
Our instructional designers are experienced in every aspect of
developing quality performance-based training. Depending upon
your specific needs, our training solutions can be delivered as
leader-led plant floor training or as workshops, electronic
presentation, performance support tools, or operating and
procedure manuals – fully integrating into your Learning
Management System. We also have a full array of workshops and
seminars covering a variety of technical and soft skill subjects that
we are able to present to meet your immediate training needs.
Generally, we are capable of providing the following training
services:
E
A
Documentation Services
We are able to provide the
following documentation
development services.
DOCUMENTATION
ASSESSMENT – Analysis of
your current documentation – provide recommendations for
improvement
DOCUMENTATION
PREPARATION
DOCUMENTATION REVIEW
SCIENTIFIC AND TECHNICAL
WRITING TRAINING
Workshops and Seminars
We are able to custom-tailor the following workshops and seminars
at your location:
Effective Communications
Delegation
Coaching and Feedback
Developing Associates
Setting Performance Standards and Expectations
Effective Meetings
Creating a Shared Vision
Introduction to Standardization
Managing Change
Rational Troubleshooting
Total Productive Maintenance
Overview
Introduction to Total Productive
Maintenance
Total Productive Maintenance
in Process Industries
Building a Continuous
Improvement Program
Building an Effective Work
Team
Conducting Performance
Evaluations and Reviews
We believe that people are the key to competition in today’s marketplace
and that training and performance management are the tools that keep that
competitive edge sharp
.......competence is the prerequisite to competition.......
DOCUMENTATION
SERVICES
We are able to provide the
following documentation
development services.
DOCUMENTATION
ASSESSMENT – Analysis of
your current documentation – provide recommendations for
improvement
DOCUMENTATION
PREPARATION
DOCUMENTATION REVIEW
SCIENTIFIC AND TECHNICAL
WRITING TRAINING
WORKSHOPS AND
SEMINARS
We are able to custom-tailor the
following workshops and seminars
at your location:
Effective Communications
Delegation
Coaching and Feedback
Developing Associates
Setting Performance Standards
and Expectations
Effective Meetings
Creating a Shared Vision
Introduction to Standardization
Managing Change
Rational Troubleshooting
Total Productive Maintenance
Overview
Introduction to Total Productive
Maintenance
Total Productive Maintenance
in Process Industries
Building a Continuous
Improvement Program
Building Effective Work Teams
Conducting Performance
Evaluations and Reviews
Competency Modeling
Performance Analysis
Curriculum Design
Training Material Development
Training Presentation
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C. H. Paul Consulting, Inc.
Compliance Support
eeting the requirements of the FDA and other regulatory
agencies is becoming one of the most difficult tasks
regulated industries have to face today. Regulatory pressure is
increasing and the penalties for non-compliance have become
more severe than ever before. At the heart of this issue are
Standard Operating Procedures – the most neglected but most
critical regulatory aspect of running any plant.
Our technical writers and analysts are intimately familiar with
Good Manufacturing Practices and their requirements for sound,
usable, and technically accurate process and operating
documentation.
We are able to provide a variety of services in this regard from
producing isolated procedures and fielding teams of technical
writers to your location to complete significant numbers of these
procedures, to training your staff to write, evaluate, and approve
these documents.
We have also designed a process that effectively enables SOP’s to
be multi-use for regulatory compliance, training, and
process/production control saving considerable resources and
significantly reducing the document maintenance burden.
M
COMPLIANCE SUPPORT
SERVICES
We are able to provide the
following compliance support services:
SOP REVIEW – Review of SOP documentation to determine
level of compliance, technical
accuracy and completeness, and
applicability for other uses.
SOP WRITING
WORKSHOPS AND SEMINARS
- Standard Operating
Procedures – An overview
- Writing Standard Operating
Procedures
- Reviewing and Approving
Standard Operating
Procedures
“Current Good Manufacturing Practices have taken on
new significance in this era of multinational suppliers of
pharmaceuticals and foods. Cross-licensing, joint
ventures, strategic alliances, mergers, acquisitions, and
divestitures underscore the necessity of maintaining
standards of manufacturing and quality control across the
geographical boundary of suppliers and distributors!”
……SOP’s that are effectively prepared and applied,
bring GMP requirements to the reality of every aspect of
the production process……
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C. H. Paul Consulting, Inc.
Enterprise System Performance Support
t has been our experience that most enterprise system user
documentation and training fails to achieve its fundamental
purpose...to make life easy for the user! Failure usually occurs
after several million dollars have been spent for the system and
most of the available time before “go-live” has been expended in
the development and customization of the software leaving no time
for substantive end-user training or the preparation of effective
user support tools.
Failures occur for several reasons:
Companies that successfully implement enterprise resource
systems have realized significant benefits by properly preparing
users to effectively perform their jobs using these integrated
software systems as job tools.
I
Technical writers rather than human performance engineers
usually write training and documentation.
Technical writers have no idea of how adults learn, how work is
performed, or how the human brain controls the performance of
complex tasks. The end products produced consists of
information that is not easily accessed, assumes a level of system
knowledge that simply does not exist, and that is organized
around the command architecture of the software rather than
around the specific job tasks performed by the user.
Documentation is punishing to use, not easily accessed when
needed, and not easily updated when system changes are made.
Training does not properly prepare the user to fully utilize the
system and the user support tools available.
ENTERPRISE SYSTEM
SUPPORT
We are able to provide the
following enterprise system
performance support services:
BUSINESS PROCESS ANALYSIS AND MAPPING –
Enterprise systems should only
be implemented after the
business system has been optimized.
INFORMATION
REQUIREMENTS ANALYSIS – The information needs of each
job category should drive ERP
system content and function not
simply what is available from the vendor.
CHANGE MANAGEMENT
STRATEGIES – The impact of
an ERP system implementation
on the workforce can slow forward progress to a crawl if
change management is not
carefully handled.
END-USER TRAINING AND
SUPPORT STRATEGIES –
effectively produced ERP
documentation and training is critical to a successful
implementation.
TRAINING DELIVERY
EXECUTIIVE EDUCATION
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C. H. Paul Consulting, Inc.
Our consulting interventions start with senior management as we
begin to understand your business strategies and goals. Next, we
help to redefine your business strategies to optimize all business
processes. There is nothing worse than implementing a new
system to automate a bad process.
We basically serve as advocates for your users – the people who
will be using the new ERP system to complete their daily work –
from your senior executives to your plant floor workers. Our
solutions transform your business by linking user requirements,
your business strategies, priorities and goals, and the new system
together into a single cohesive functioning entity.
ENTERPRISE END-USER
MATERIALS AND
TRAINING
The enterprise end-user materials
and training systems we develop are designed to meet the following
requirements and objectives:
Procedures are organized
by job task in a format that
is easy to update as system
changes occur.
Users are able to interact
with the system with little
or no difficulty.
The training system
enables users to become
proficient in system use in
a very short period of time
Users are able to quickly
access infrequently used
information in support of
relevant job tasks
User support tools are easily
accessed through a variety of
media.
To compete in today’s fast-paced technological society it has
become imperative to provide managers and staff with the
tools to perform their job functions efficiently and effectively.
The time simply is not available to learn .....on-the-job...... If
people are our competitive edge and technology is the tool
people use in order to compete, then major systems provide
the direction and control for the entire process.
....people, training, and information.....seed for the future....
Copyright © 2013 C. H. Paul Consulting, Inc., Tobyhanna, PA - All Rights Reserved 17
C. H. Paul Consulting, Inc.
Performance Manufacturing
erformance Manufacturing is a modified lean manufacturing
approach to maximizing the effectiveness of your production
processes. It is an interlocking combination of carefully designed
processes built on a foundation of solid equipment maintenance
achieved through the implementation of Total Productive
Maintenance Programs.
Performance Manufacturing generates “real” process
improvements substantially improving the operational
measurements for customer service and quality, equipment and
manpower utilization, downtime, throughput, inventory,
changeover time, parts utilization, waste, and rework.
We have been implementing Performance Manufacturing systems
within the fortune 500 since the late 1970’s, long before the terms
“Lean Manufacturing” and “Total Productive Maintenance” were
ever coined.
The problems that our approach typically addresses include:
P
Start-up of new facilities
Unacceptable downtime
High scrap and rework levels
Failure to meet planned production values
Accidents
Changeover and setup time reduction
Transfer of new manufacturing technology
Poor product quality
Equipment deterioration
Need to hire/train large numbers of employees
PERFORMANCE
MANUFACTURING
COMPONENTS
Our Performance Manufacturing
Process consists of the following components and services:
REENGINEERING AND
STANDARDIZATION OF
PROCESSES AND
OPERATIONS
JOB INSTRUCTION
TRAINING
INSPECTION-BASED
TOTAL PRODUCTIVE
MAINTENANCE
SYSTEMS
CONTINUOUS
IMPROVEMENT
CHANGEOVER
REDUCTION
LOSS ELIMINATION
CONTINUOUS FLOW
AND WASTE
ELIMINATION
KAIZEN – QUICK
IMPROVEMENTS
CUSTOM-TAILORED
LEAN MANUFACTURING
TRAINING
Copyright © 2013 C. H. Paul Consulting, Inc., Tobyhanna, PA - All Rights Reserved 18
C. H. Paul Consulting, Inc.
The Quick Response Performance Manufacturing
Improvement Model
Tasks Typically Documented
Start-up and shutdown procedures
Loading materials
Operational adjustments
Clearing jams
Removing, replacing, rebuilding, and
adjusting key components
Monitoring production
Changeover and setup
Cleaning
Quality checks
Preventive maintenance GMPs and Safety
REENGINEER &
STANDARDIZE
OPERATIONS
Standardizing what each worker does is critical to
ensuring that tasks are performed consistently from
worker to worker across all shifts.
Without consistency there is no control. Much
downtime and waste throughout any manufacturing
plant is due to the variation introduced by individual
workers.
Without standardization, workers evolve their own
methods of performing critical tasks, which may or
may not be effective and may even contribute to poor
utilization, unscheduled downtime, and catastrophic
failure.
JOB
PROCEDURE
TRAINING
Job Procedure Training is provided for both
operators and mechanics.
Workers are trained and certified in the use of the
checklists and procedures that are prepared during the
standardization phase of the project. The training
program is customized to each specific job and item
of equipment. The training provides workers with
general technical knowledge and specific skills that
are essential to achieving competence in the operation
and maintenance of any system.
Certification insures that trainees are able to perform
learned tasks after training.
Copyright © 2013 C. H. Paul Consulting, Inc., Tobyhanna, PA - All Rights Reserved 19
C. H. Paul Consulting, Inc.
DIAGNOSTICS
TRAINING
The most time critical event in machine maintenance
is troubleshooting equipment problems. To minimize
downtime, it is essential to first rapidly identify major
trouble symptoms and then eliminate them in a
prioritized and systematic way.
The basic elements of our approach include the
following:
Task Analysis: “Master Performers” are observed as
they correct malfunctions in order to analyze and
catalog the processes they follow.
Prioritizing Tasks: 20% of the problems cause 80%
of the downtime. Our approach concentrates on the
most frequent and critical malfunctions.
Designing Job Aids: Job aids are prepared for each
item of equipment. They guide mechanics to the
location of the trouble, indicate the corrective action
to be taken, and specify the parts to be replaced
and/or the adjustments to be made.
Designing Training: A training program is
developed to transfer the skills and techniques
identified during the task analysis portion of this
phase.
Designing Job Certification: Job certification is an
on-the-job demonstration of the mechanic’s ability to
accomplish a troubleshooting task.
Copyright © 2013 C. H. Paul Consulting, Inc., Tobyhanna, PA - All Rights Reserved 20
C. H. Paul Consulting, Inc.
For technology to be effective, it requires a blend of man and machine
working in concert to achieve maximum output. Our firm views
improving performance effectiveness by implementing programs that
maximize the blend of machine, labor, materials, and management.
Let our experienced professionals put you on the leading edge of
technology.
........Man and Machine Working Together.........
INSPECTION-
BASED
MAINTENANCE
Most approaches to equipment maintenance are
reactive at best with workers responding to failure
only after equipment has ceased functioning – “fix it
when it breaks.” Production equipment is the heart
of the manufacturing process. If it doesn’t run you
don’t make product. If it doesn’t run well, you can’t
meet your commitments and production
requirements.
The answer is to implement an inspection-based
maintenance system in which everyone in the plant
participates from custodian to equipment mechanic –
“maintain it so it never breaks.”
The three major causes of malfunction in any
machine system are dirt/contamination, loose or
missing fasteners that create vibration, misalignment,
catastrophic failure, and lack of lubrication. The
process empowers workers with the responsibility of
maximizing equipment operation, effectiveness, and
maintainability by:
Inspecting equipment on a periodic basis
throughout the shift
Maintaining a clean work environment
Lubricating equipment on a periodic basis
Tightening fasteners on a periodic basis
Replacing component parts
Developing systems and approaches to
improve maintainability
A detailed Machine Analysis is conducted to
determine the specific inspection, lubrication,
cleaning, and preventive maintenance requirements
that must be met in order to assure maximum
effectiveness. A training program is designed and
presented that provides the skills workers need to
utilize all facets and components of the system.
Key Components
Determining equipment
effectiveness
Six losses elimination
Establish basic
equipment conditions
Prepare daily inspections
Standardize maintenance
activities
Maintenance planning
Lubrication control
Maintenance prevention
Kaizen
Copyright © 2013 C. H. Paul Consulting, Inc., Tobyhanna, PA - All Rights Reserved 21
C. H. Paul Consulting, Inc.
Training Capability Building
he highly technical and fast-paced world of today's worker
requires that complex tasks and job activities be mastered
quickly and be performed with great accuracy. To compound these
requirements, workers are increasingly being organized into work
teams or work groups with the responsibility of training/cross-
training their peers in new job activities and tasks. Traditional
classroom training methods that were sufficient to train the worker
of yesterday simply can't guarantee consistent standardized
performance to meet today's needs. Using outside training
resources may no longer be a viable alternative to meeting internal
training requirements. Companies are operating "lean and mean"
without the staffing flexibility to hire permanent training
professionals.
Our Building Training Capability Program is a combination of
consulting interventions, consulting projects, and training
workshops that creates an internal training function within the
facility, specifies the training that needs to be accomplished, and
forms and trains a training team.
Job/Task Analysis
The Job/Task Analysis is a three-step process. During the first step,
Develop and Validate Task Listing, a valid list of tasks is
developed for each job function. This step defines the scope or
boundary conditions of the task analysis and focuses and controls
actual analysis activities such as scheduling interviews, and the
review of relevant supporting information.
During the second step, Analyze Each Individual Task, each task is
analyzed to determine those characteristics that influence training
design and planning.
During the third step of this process, Develop Performance
Objectives, behavioral objectives are developed for each task
analyzed. Performance objectives specify what the learner will
accomplish as a result of having received the instruction.
T
TRAINING CAPABILITY
BUILDING
Our Training Capability Building
Process consists of the following
components and services:
The development of a
detailed job analysis for each
function and job position to
serve as a basis for a plant-
wide training plan, training
curriculum, and certification
program.
The development of a job
specific training design and
training plan that details the
training each job incumbent
must complete in order to be
qualified and certified in the
position.
The development of a
training curriculum that
specifies courses for each
job position, training content,
training modules, training
materials, training times, and
training requirements.
The development of a
performance-based job
certification program that
objectively assesses a
worker's level of job
competency before and after
training.
The establishment of a
training team. Team
members are trained in
training development, needs
assessment, training analysis,
preparation and presentation
skills, coaching for improved
work performance, and the
skills required to conduct a
certification program.
Three consultant audits of
training conducted every
three months for one year
after the completion of the
project.
Copyright © 2013 C. H. Paul Consulting, Inc., Tobyhanna, PA - All Rights Reserved 22
C. H. Paul Consulting, Inc.
Training Design, Training Plan and Training Curriculum
Once the Job/Task Analysis has been completed, it is then possible
to begin curriculum planning for each of the learner’s job
functions. The task data generated for the Job/Task Analysis
provides the supporting information for the preparation
component. The curriculum specifies the training sequence, the
commercially available training materials that should be
purchased, a detailed design of all custom-designed materials that
should be prepared to enhance and integrate the various materials
into a cohesive training program, coordination with vocational
schools and community colleges to provide any needed relevant
instruction, and a detailed implementation plan for all aspects of
the instructional program.
Certification Program
Job Certification is a performance-based procedure designed to
insure that all workers are able to successfully perform the tasks
comprising their job. The certification process, administered before
undertaking training, provides a performance baseline against
which all training skill gains can be measured. After training, the
administration of the certification process provides a basis for
measuring mastery of learned skills and any requirements for
remedial training.
Trainer Training Program
The Trainer Training Program is designed to be presented to non-
professional trainers who have extensive experience in their field
or craft but have little or no formal experience presenting training.
Participants must demonstrate competence at the end of the
workshop by developing and preparing a simple training program
utilizing all of the skills mastered. Trainees are evaluated and
certified as trainers at the completion of the program. The
consultant support time after the completion of training is used to
evaluate instructors on a periodic basis and to provide support and
assistance where needed to insure that a minimum standard is
being maintained.
PROGRAM BENEFITS
A formalized training curriculum prepared and used
as a guide in the administration
of job specific training.
A trained and certified training
team functioning from within the facility.
Company training and cross-
training needs satisfied
economically and effectively.
Training is performance-based
with a certification element to
insure individual success.
Job performance improved throughout the facility.
“Provide individuals with a fish and they will be able to eat for today, teach
those same individuals to fish and they will be able to eat for a lifetime.”
..…the only answer to the training of today's workforce is self-
sufficiency……
Copyright © 2013 C. H. Paul Consulting, Inc., Tobyhanna, PA - All Rights Reserved 23
C. H. Paul Consulting, Inc.
Management/Leadership Development
rganizations like people sometimes fall short of realizing
their full potential and achieving their goals. Obsolete ideas,
lack of proper focus, direction and trust, cumbersome management
structures, lack of effective performance management, inability to
retain key employees, and the lack of teamwork, all seriously
hinder forward progress and threaten the competitive edge.
Organizational development is defined as the planned,
organization-wide effort to increase an organization’s effectiveness
by improving the processes that define it.
Through the implementation of our approach our clients have been
able to:
To be effective, management training must be directly relevant to
the participant’s job, working environment, and corporate vision
and goals. Most management training programs fail because they
are simply too generic to have any real meaning for the participant.
After training, participants are expected to transfer the generic
skills and knowledge they have learned to their actual job. A very
difficult feat for even the most sophisticated!
Our approach is to develop management training that is specific to
the job, reflects the corporate culture and vision, and addresses the
problems and issues endemic to the organization.
O
Improve management communication and team effectiveness
Focus efforts and energy on the things that count – profit,
quality, customer service, competitive edge, growth, and
innovation.
Improve operational and administrative processes
Improve manager to manager and manager to labor
communication and trust
Build leaders that are capable of leading the organization to
greater market position and growth
MGT & LEADERSHIP
DEVELOPMENT
Our Management/Leadership
Development Process consists of the following components and services:
JOB/TASK ANALYSIS &
DESIGN
PERFORMANCE ANALYSIS
OPERATIONAL STUDIES
REENGINEERING
SKILLS ASSESSMENT
MANAGEMENT TRAINING
DYNAMICS OF LEADERSHIP
Level 1: Managing Your Relationships
Creating a Shared Vision
Communicating Effectively with
Production Team Members
Giving Clear and Unbiased Information on the Manufacturing
Floor
Working with Customers and Suppliers
Impacting the Manufacturing Process
Level 2: Managing Your Job
Maximizing Management Time
Identifying and Solving Manufacturing
Problems
Making Manufacturing Decisions and
Weighing Risk
Building a Continuous Improvement Program
Effective Equipment Operation in the
21st Century Plant
Level 3: Managing Others
Training the Production Team
Providing Coaching & Feedback to Production Team Members
Discipline & Counseling within the
Manufacturing Environment
Leading Effectively in a Chaotic
Environment
Copyright © 2013 C. H. Paul Consulting, Inc., Tobyhanna, PA - All Rights Reserved 24
C. H. Paul Consulting, Inc.
Another reason why management training fails is because it does
not have the support of senior management. Our approach
involves senior management at every level of the process – design,
development, and program implementation.
Our development process consists of five key phases.
Management Development Model
Research &
Design
Achieve
Buy-in
Develop Core
Modules
Modules
Self-
Study
Mentor
Meetings
Workshops Real
Deliverables
Phase I – Research and Design
Phase II – Achieve Buy-In
Phase III – Develop Core Modules
Phase IV – Implementation
Phase V – Transfer Skills
DEVELOPMENT PROCESS
Phase I – Research & Design
Understand core issues
Conduct assessment
Compile information
Determine job requirements
Design the curriculum
Gather relevant information
Phase II – Achieve Buy-in
Gain “buy-in” from stakeholders
Seek agreement – curriculum
and instructional approach
Advertise the program –
expectations, benefits, and
expected results
Phase III – Develop Modules
Create personalized core
modules that support completion of “real” deliverables
Determine delivery method(s)
Conduct pilot training and revise
the program
Develop Mentoring Program
and select mentors
Phase IV – Implementation
Train corporate trainers
Train mentors
Develop training plan
Support trainers
Phase V – Transfer Skills
Conduct post training
assessment
Monitor mentor meeting
activities
Consult with senior management
Monitor performance
Copyright © 2013 C. H. Paul Consulting, Inc., Tobyhanna, PA - All Rights Reserved 25
C. H. Paul Consulting, Inc.
What Are Some Specific Examples?
esigned a management leadership-training program for a major distributor of retail
foods. Trained over 200 instructors to administer the program throughout the
United States.
Developed system documentation and user training for a corporate-wide enterprise
management system. The $25,000,000.00 system addressed virtually all of the
corporation’s functional areas. The implementation required almost fourteen months of
material development and training preparation.
Designed a company-wide self-directed work team program and implementation plan for
a major pharmaceutical manufacturer. The five-year implementation plan addressed
issues of manpower, system optimization, training, and team responsibility.
Designed a leadership development curriculum for pharmaceutical operations consisting
of ten custom-designed and company specific workshops covering skill deficiencies
uncovered during a corporate-wide assessment. Trained corporate trainers to administer
the program at all plant locations.
Established an internal plant technical training function for a major manufacturer of
cosmetics and hair-care products. Performed a detailed job/task analysis to support their
pay-for-skills program, developed a plant-wide technical training curriculum, established
and trained a technical training work cell, and monitored operations until expectations
were met.
Assisted a major manufacturer of pharmaceuticals to consolidate the manufacturing
operations of three plants into a new fourth location. Developed and implemented
standardized manufacturing methods, technical worker training, and preventive
maintenance systems for all installed manufacturing equipment. The project also
consisted of analyzing manufacturing and training functions at four plants in three
European countries.
D
Copyright © 2013 C. H. Paul Consulting, Inc., Tobyhanna, PA - All Rights Reserved 26
C. H. Paul Consulting, Inc.
Assisted a major manufacturer of pharmaceuticals to consolidate the manufacturing
operations of three plants into a new fourth location. Developed and implemented
standardized manufacturing methods, technical worker training, and preventive
maintenance systems for all installed manufacturing equipment. The project also
consisted of analyzing manufacturing and training functions at four plants in three
European countries.
Contact Us!
ontact us and we will be happy to meet with you to discuss you issues, concerns,
and your needs.
Our partners manage all client contacts from initial client meeting to project completion.
C. H. Paul Consulting, Inc.
48 Thoreau Road
Hamilton Square, NJ 08690 609-587-8358
(F) 609-587-1423
cpaul19436@aol.com
C
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