pharmaceutical/foods capability brochure

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

http://www.chpaulconsultinginc.com/

Copyright © 2013 C. H. Paul Consulting, Inc., Tobyhanna, PA - All Rights Reserved 2

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.



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!



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.



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.



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.



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:

T

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……



Where Our Services Apply

he techniques we utilize to implement change and improve

performance apply to a great many areas of critical work.

T

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……



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.



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.



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



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.

W

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……



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


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


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


Introduction to Standardization

Managing Change

Rational Troubleshooting


Overview

Introduction to 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



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


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……



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


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



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....



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



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.



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.



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



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.


training curriculum that

specifies courses for each

job position, training content,

training modules, training

materials, training times, and

training requirements.


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.



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……



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


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



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



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



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.


48 Thoreau Road

Hamilton Square, NJ 08690 609-587-8358

(F) 609-587-1423

[email protected]

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pharmaceutical/foods capability brochure

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