Pharmaceutical/Foods Capability Brochure

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Pharmaceutical/Foods Capability Brochure

  1. 1. ForRegulated Industrial OperationsLet us help you achieve aQuick Response to theproblems facing yourcompany!Introducing Quick Response……The unique consulting approach thatwill change your company forever!Let us help you achieve world-class compliance, quality, andmanufacturing excellence!C. H. Paul Consulting, Inc.7370 Ventnor DriveTobyhanna, PA 19466570-216-4571www.chpaulconsultinginc.com
  2. 2. Copyright © 2013 C. H. Paul Consulting, Inc., Tobyhanna, PA - All Rights Reserved 2C. H. Paul Consulting, Inc.C. H. Paul Consulting, Inc.t C. H. Paul Consulting, Inc. we provide our regulatedclients (pharmaceutical, medical devices, consumerproducts, cosmetics, foods, etc.) with a wide range of consultinginterventions designed to improve the efficiency and effectivenessof their workers in technology-driven regulated workenvironments, meet world-class compliance requirements, andachieve manufacturing excellence!We have been serving our corporate clients for over 25 years witha practice dedicated to dramatically affecting client performanceand profitability through improved competence.The Challengeusiness has changed radically over the last 20 years. Theemergence of new technologies, intense competition,shortage of trained workers, and heightened regulatory scrutiny hascreated an environment where companies must respond quickly tothe problems facing them with a measured response that minimizesrisk and maximizes results. Our answer to helping you meet thesechallenges is our Quick Response approach.Quick Response is not a product but a methodology for deliveringconsulting services that quickly address the “real” problemsholding you back from achieving your goals.A Quick Response solution will help you to:ABOUR QUICK RESPONSESERVICES ANDSOLUTIONS PLANT FLOOR TRAINING &NEW PLANT START-UPSUPPORT – Job training foroperators, mechanicstechnicians, and first-linesupervisors. DOCUMENTATION ANDTRAINING – Training anddocumentation solutions thatfocus exactly on the skills andknowledge needed to do the job. COMPLIANCE SUPPORTFOR REGULATEDINDUSTRIES – SOP/GMPevaluation, development, andtraining. ENTERPRISE SYSTEMPERFORMANCE SUPPORT –Preparing workers to performtheir jobs using integratedenterprise-wide softwaresystems. PERFORMANCEMANUFACTURING – LeanManufacturing ConsultingServices for our industrialclients. TRAINING CAPABILITYBUILDING – Helping ourclients to build trainingcapability within theirorganizations. MANAGEMENT/LEADERSHIPDEVELOPMENT – Helpingmanagers to meet the leadershipchallenges of the new century. Quickly identify where performance discrepancies exist. Quickly build project teams to address those discrepancies. Formulate and implement approaches to the problemsidentified. Transform the company into a learning organization that isarmed with the knowledge to achieve excellence.
  3. 3. Copyright © 2013 C. H. Paul Consulting, Inc., Tobyhanna, PA - All Rights Reserved 3C. H. Paul Consulting, Inc.Regulation Issueshere are five key regulatory issues concerning personnel,training, and task performance that must be carefullyaddressed in order to be in compliance.These issues include:Failing to address any or all of these points opens a significantwindow of vulnerability for any regulated operation.Our Quick Response process is designed to meet and address eachof these issues.T Requirements that all personnel must be “trained in theparticular operations the employee performs and in currentgood manufacturing practice (CFR regulations and the writtenprocedures required by the CFR regulations)” in order to bequalified to perform those job. Implied requirements that there be a system in place thatdocuments training performed by employees on an “on-going”basis. Requirements that written procedures be prepared in the formof SOPs. Requirements that all tasks performed for which SOPs exist beperformed in accordance with those SOPs. Implied requirements that SOPs be specific and complete fullydescribing the tasks to be performed to include all metrics, tools,cleaning materials, replacement parts, etc.SOPS REQUIRED AS AMINIMUM Cleaning and maintenance ofequipment including utensils Calibration of automatic,mechanical, and/or electronicequipment Production and processcontrol Identifying strength, quality,and purity of products In-process controls, tests orexaminations of batchsamples Preventing objectionablemicroorganisms fromentering products notrequired to be sterile Preventing contamination ofsterile products Prescribing a system forreprocessing batches Receipt, identification,storage, handling, sampling,examination, and/or testing oflabeling and packagingmaterial Warehousing of products Distribution of drug products Calibration of instruments,apparatus, gauges, andrecording devices Sampling and testing Stability testing program Testing sterile or pyrogen-free drug products Testing controlled-releasedrug products Evaluation of drug products Preparation of masterproduction and controlrecords TrainingCompliance is not a paper exercise designedto meet the requirements of regulatoryagencies. Rather, it establishes the rules ofwork and guarantees the efficacy of theproducts produced for the consuming public!
  4. 4. Copyright © 2013 C. H. Paul Consulting, Inc., Tobyhanna, PA - All Rights Reserved 4C. H. Paul Consulting, Inc.Regulatory Scrutiny is Realn a search of past warning letters it is clear that the FDA isplacing particular emphasis on the five key regulatory issues.Requirements that all personnel be trained:“Failure to ensure that all personnel are trained to adequately performtheir assigned responsibilities and to document the training, as required by21 CFR 820.25 (b). For example:The QA Technician was releasing finished goods into finished goodsinventory without documented training or authorization. The onlypersonnel authorized to release finished devices into finished goodsinventory are the Directors of QA and Regulatory Affairs (RA), and theSupervisors of QA and RA.”Implied requirements that there be a system in place thatdocuments training and that training be on-going:“The QA Inspector responsible for testing and acceptance activities doesnot have any documented training prior to xx/xx/xxxx although theinspector has been employed since xxxx.”Requirements that procedures be prepared as SOPs:“Failure to establish and maintain procedures to prevent contamination ofequipment or product by substances that could reasonably be expected tohave an adverse effect on product quality 21 CFR 820.70 (e) in that there isno SOP describing the proper technique to be employed for handlingstoppers used for lyophilized products during weighing procedures.Stoppers used for lyophilized products were observed being weighed in anopen warehouse on a dirty cart; the operator weighing the stoppers wasobserved handling the stoppers with bare hands. Stoppers are not washedprior to use.”Requirements that all tasks must be performed in accordancewith SOPs:“During the manufacture of Pulmozyme bulk lot #XXXXX, manufacturingpersonnel reduced the agitation rate from the specified ________ after thebulk began to foam. No justification was provided for choosing thealternate mixing speed or explanation of why foaming occurred.”IFIVE REGULATORYISSUES All personnel must be trainedin the particular operationsthe employee performs and incurrent Good ManufacturingPractice. System must be in place thatdocuments on-goingemployee training. Written SOPs must beprepared that address allfacets of operations. SOPs must be specific andcompletely describe the tasksto be performed.
  5. 5. Copyright © 2013 C. H. Paul Consulting, Inc., Tobyhanna, PA - All Rights Reserved 5C. H. Paul Consulting, Inc.SOPs must be specific and complete:“The SOP entitled “QA Release Department Review of Batch ProductionRecords and Test Results” is inadequate in that it allows manufacturingsupervisors to make changes to batch records without the knowledge orconsultation of the manufacturing employees that were involved in thediscrepancies.”“SOPs do not describe the requirements for mixing of the sample ofabsorbed Pertussis Toxoid intermediates, bulk product, or final filledcontainer prior to removing an aliquot for pH testing. Percentadsorption, thimerosal, and aluminum testing is also performed on thealiquot, for which lack of mixing could affect the test results”“Media fill procedures do not describe required activities in response toa failure.”“SOP 21T69 does not specify a holding time limit for a sample prior totesting.”Achieving Compliance & Operations Excellencehere are four basic areas other than chemistry and biologythat contribute to compliance failures within any regulatedoperation.Training – When workers do not know what to do or how to do it,they cannot be expected to perform tasks in compliance with SOPsand applicable regulations. “Training” for the industry in generalis varied ranging from having employees read SOPs on a frequentbasis as “training” to the conduct of an actual formal trainingprocess that includes a combination of classroom and “hands-on”job practice, and formal knowledge and skill testing supported bycomprehensive reference documentation. The small group withinthe industry that suffers the misconception that reading SOPs istraining, place their organizations at great risk from a compliance,safety and environmental standpoint.Documentation (SOP’s) – The work instructions prepared in theform of SOPs that form the rules of work in any regulatedorganization should be built to serve three basic functions – astraining documents, as on-the-job reference documents, and tosatisfy compliance requirements. As a training document, SOPsform the basis of instruction focusing on those skills andknowledge that are critical to the performance of the job. As on-the-job reference documents, SOPs eliminate the requirement thatthe trainee remember multi-step complex tasks and ensureTCOMPLIANCE FAILURESTRAINING Workers don’t know what todo. Training is poor. Training is infrequent. Training is not relevant tospecific job tasks andprocedures. There are no objectivestandards for determiningcompetence. Training conducted is notdocumented.DOCUMENTATION Documentation notsufficiently detailed. Documentation notmaintained. Documentation not readilyaccessible. Documentation punishing touse. Tasks not performedaccording to documentation.ACCOUNTABILITY No consequences associatedwith non-performance.SUPERVISION Supervisors/managers do notenforce compliantperformance.
  6. 6. Copyright © 2013 C. H. Paul Consulting, Inc., Tobyhanna, PA - All Rights Reserved 6C. H. Paul Consulting, Inc.performance to 100% of the specified standard in terms of thesequence of events, tools, parts, and materials used,administrative/reporting requirements, the safety precautions thatmust be taken, and any environmental considerations. Ascompliance documents SOPs should be sufficiently detailed so thatan individual with minimal training would be able to perform thetask using the document as a reference. Previously, there was aschool of thought in the pharmaceutical industry that generalizingthe content of SOP’s would provide manufactures with sufficientlatitude to explain discrepancies when questioned by FDA or otherregulatory inspectors. This is no longer the case. A review ofwarning letters will show time after time the attention andimportance attached to this documentation and the level of scrutinythat they attract.Accountability – All of the training and documentation in theworld will not ensure compliance. There must be consequencesassociated with non-performance or incorrect performance.Personnel must be held accountable when they short-cut or ignoreregulated procedures, work methods, or other specified jobrequirements. Without accountability there can be no “comfort-level” as to the work performed and if that work is in compliancewith all SOPs and regulations.Supervision – Supervision must never ignore or avoid theirresponsibilities in terms of work performance. Supervision mustbe knowledgeable of the SOPs that dictate how the work withintheir area of responsibility must be performed, demand fullcompliance to those SOPs, monitor how work is performed, andadminister counseling and discipline when deviations occur.In order to be cost effective, develop your compliancedocuments once!!! Documentation should meetregulatory requirements, should support technical jobtraining, and should be available as user-support jobtools!WELL-DESIGNED ANDDEVELOPEDCOMPLIANCEDOCUMENTATION Documentation is sufficientlydetailed so that a noviceperformer can follow thelisted instructions andperform the task perfectly. Documentation is highlyillustrated to eliminateconfusion and enhance utility. Documentation is producedas a minimum to addresseach task and operation asspecified by regulations. Documentation designed tosupport technical jobtraining. Documentation is easilymaintained. Documentation forms thebasis of a comprehensiveperformance improvementprocess.
  7. 7. Copyright © 2013 C. H. Paul Consulting, Inc., Tobyhanna, PA - All Rights Reserved 7C. H. Paul Consulting, Inc.Achieve Results With Quick Response!oday, competitive advantage can be lost in the blink of aneye and changes in the global economy can place yourbusiness at risk virtually every day at market close. Companiesthat are not ready to respond quickly, that do not have the supportsystems in place, and have not harnessed the collective power ofthe workforce… will fail!If you have asked yourself these questions, you need QuickResponse:T Do we have the standardized systems in place to supportperformance at all levels of the organization? Have we built a learning organization to achieve long-termcompetitive advantage? Do we have the tools to gather, maintain, and process theknowledge of our company? Is our corporate behavior aligned with our strategic goals andour vision? Do we consistently measure and manage performance? Does our corporate culture inspire personal and professionalgrowth, loyalty, dedication, and trust?OUR PHILOSOPHY!We believe that our client’sprimary business objectives mustaddress: PROFIT MAXIMIZATIONAND GROWTH – now andinto the future! PROFITABILITY,EFFICIENCY, ANDEFFECTIVENESS – increaseonly as a result of engineering,improving, measuring, andmanaging work performance! JOB ABILITY – in the form ofskills and knowledge, isacquired through on-goingtraining, performance support,and work experience! WILLINGNESS TO WORK --is maintained, enhanced, andstrengthened by satisfying theworker’s economic,psychological, and socialneeds and by building anorganization based uponmutual trust, fairness, andbasic human dignity! EXCELLENTPERFORMANCE –organizational, individual, andgroup – can be structured,improved, and sustained byapplying a systems engineeringapproach to the design,execution, and management ofwork!Our mission is to provide our clients with themeans to solve their own problems, to becometotally self-sufficient, and to maximize theutilization of their most critical resources……people, systems, and processes……
  8. 8. Copyright © 2013 C. H. Paul Consulting, Inc., Tobyhanna, PA - All Rights Reserved 8C. H. Paul Consulting, Inc.Where Our Services Applyhe techniques we utilize to implement change and improveperformance apply to a great many areas of critical work.TWHERE OUR SERVICESAPPLY Manufacturing Training and HumanResources Marketing General and AdministrativeManufacturingQuality, Maintenance, Manufacturing Operations, Production, Planning,Warehouse, and Inventory ControlTraining and Human ResourcesInstructional Systems/Curriculum Development, Training MaterialsDevelopment, and Trainer TrainingMarketingField Sales & Service, Sales Management, Installation, Repair, OrderHandling, Customer Service, and DistributionGeneral & AdministrativeInformation Technology, Customer Service, Credit & Collections, ClericalOffice, Financial Office, and PersonnelThe key to effective learning is in the process employed todevelop, present, and assess training. Effective trainingmust be:……performance based, job relevant, and include onlythe information needed to perform the tasks to bemastered……
  9. 9. Copyright © 2013 C. H. Paul Consulting, Inc., Tobyhanna, PA - All Rights Reserved 9C. H. Paul Consulting, Inc.The Quick Response ApproachPlanningPrior to beginning any Quick Response implementation, itis vital that we explore your group’s purpose, vision,strategy, and objectives to insure complete linkage andunderstand of your corporate environment and regulatorychallenges facing your associates. This step enables us toformulate a program that directly and completely meetsyour needs.AnalysisA critical analysis of the issues under investigation is nextconducted. The very last thing that anyone needs from aconsulting 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, cannotbe easily implemented, does not facilitate growth andimprovement, and does not achieve measurablequantifiable results.Approach DesignThe development of a detailed Approach Design is asfundamental to any consulting initiative as it is to thebuilding of a bridge or a high-rise building. The ApproachDesign specifies the actions, requirements, interactions,and results of each project phase.
  10. 10. Copyright © 2013 C. H. Paul Consulting, Inc., Tobyhanna, PA - All Rights Reserved 10C. H. Paul Consulting, Inc.Process DevelopmentDuring this step, the project structure for change is createdand the building blocks are set in place. Our staff works inpartnership with your associates to create the projectmaterials, activities, actions, and strategies that meet theproject requirements specified during the Approach DesignPhase.Training and ImplementationTraining is one of the vehicles used to implement theresults of any Quick Response project. Training is tailoredto meet the particular needs of each audience. Theuniversal complaint about most training is that it lackslong-term effectiveness. In far too many cases, participantssimply forget what they learned and lapse into old ways.This is because the content is not job relevant, does notsupport organizational goals and objectives, is notsupported by middle and senior management, and is not acomponent of the performance management system. Thisdoes not happen with Quick Response!Reinforcement and Systems SupportBased on your needs and environment, we will provide arange of follow-up services, including performanceassessments and studies, one-on-one coaching, focus groupactivities, and refresher training.
  11. 11. Copyright © 2013 C. H. Paul Consulting, Inc., Tobyhanna, PA - All Rights Reserved 11C. H. Paul Consulting, Inc.Our Clientsur clients are represented by many of the largest Fortune 1000 companies in theUnited States.Imclone Systems Medco, Inc. Shared Medical SystemsJohnson & Johnson SiteMicrosurgicalJohnson & Johnson Cordis Johnson & Johnson PersonalProducts CompanySanofi-Aventis Sanofi-Pasteur Frito-LayJohnson & Johnson Iolab Norwich-Eaton Pharmaceuticals SmithKline Animal HealthBlock Drug Clairol, Inc. Pepsi ColaJohnson & Johnson JanssenPharmaceuticaSmithKline Pharmaceuticals Johnson & Johnson OrthoPharmaceuticalsBristol-Myers Products Pfizer Pharmaceuticals Nitta CasingsMcCormick & Company Church & Dwight Ciba Geigy PharmaceuticalsNabisco Foods Bristol-Myers Convatec Pilot Chemical – Fine ChemicalsThe Great Atlantic & PacificTea CompanyJohnson & Johnson SiteMicrosurgicalBristol-Myers U. S.Pharmaceutical GroupBeiersdorf, Inc. Merck & Company Novartis PharmaceuticalsLederle Laboratories American Cyanamid Quaker OatsSchien Pharmaceuticals Solvay Pharmaceuticals Miles LaboratoriesAlpharma (Purepac) Nabisco Biscuit Nice PakJohnson & Johnson ConsumerProducts -- LiquidsJohnson & Johnson BabyProducts CompanyJohnson & Johnson ConsumerProducts – Wound CareMcNeil Consumer Healthcare Pfizer Animal Health ColgateHills Pet Foods Aventis DendreonSandoz Johnson & Johnson Ortho-Clinical DiagnosticsJohnson & Johnson NeutrogenaO
  12. 12. Copyright © 2013 C. H. Paul Consulting, Inc., Tobyhanna, PA - All Rights Reserved 12C. H. Paul Consulting, Inc.Plant Floor Trainingorkers will excel only when they are comfortable in doingthe work assigned and they have a reasonable expectationof success. The key to achieving this functioning state is jobcompetency!We have been developing plant floor training for over 25 years!Our process has stood the test of time and has only been enhancedby the application of new learning and documentationtechnologies.We are dedicated to providing workers with the tools and trainingthey need to be successful on the job and companies with theresults they need to minimize costs, improve product quality,improve customer service, and maximize production effectiveness.Generic manufacturing technology training does not produce thetransference of skills to actual situations that is critical to sustainedefficient plant operations. To be effective, plant floor training mustbe specific and custom-designed to the workers jobs and theequipment and processes they operate. Our training minimizestraining times by only training those skills that are required toperform 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 basiswith client representatives and are designed and implemented to bepresented and maintained by in-plant personnel to ensure self-sufficiency and ownership.Most importantly, the technical training component is aCertification Training Approach. This means workers areperformance tested and certified as able to perform learnedtasks...BEFORE...being released to the production environment.WPLANT FLOOR TRAININGOur performance-based plantfloor training includes: JOB ANALYSIS AND DESIGN –Used to develop staffing plansthat assure efficient teamoperations and serve as the basisfor job training and skill-basedpay system implementation. CURRICULUMDEVELOPMENT – Custom-designed technical trainingcurriculums developed tosupport performance-basedincentive systems, leanmanufacturing staffingstrategies, training deliveryconstraints and requirements,and job enhancement andenrichment requirements. PERFORMANCE SUPPORTTOOLS – Job aids to supportthe performance of criticaltasks – electronic or paper-based. TRAINING TOOLS –Instructortools to streamline the learningprocess and guaranteemastery. TRAINING DELIVERYSUPPORT – Development ofstrategies to maximize theeffectiveness of trainingdelivery across the workforce. IMPLEMENTATIONSUPPORT – Training ofcorporate assets to administerand maintain the trainingsystem produced. CERTIFICATION –Development of performance-based certification instrumentsthat 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……
  13. 13. Copyright © 2013 C. H. Paul Consulting, Inc., Tobyhanna, PA - All Rights Reserved 13C. H. Paul Consulting, Inc.Documentation Servicesffective documentation is the key to creating a learningorganization. Without it, there is no basis for improvement,no basis for “lessons learned,” and no basis for solving currentproblems.The technical documentation that we produce is user-friendlymeets ISO, regulatory, and other documentation requirements andcan easily be used for both instructional and performance support.Training Servicess a full service performance consulting firm, we are able todesign curriculum and prepare training materials to meet avariety of training needs for many job categories and functionalareas.Our instructional designers are experienced in every aspect ofdeveloping quality performance-based training. Depending uponyour specific needs, our training solutions can be delivered asleader-led plant floor training or as workshops, electronicpresentation, performance support tools, or operating andprocedure manuals – fully integrating into your LearningManagement System. We also have a full array of workshops andseminars covering a variety of technical and soft skill subjects thatwe are able to present to meet your immediate training needs.Generally, we are capable of providing the following trainingservices:EADocumentation ServicesWe are able to provide thefollowing documentationdevelopment services. DOCUMENTATIONASSESSMENT – Analysis ofyour current documentation –provide recommendations forimprovement DOCUMENTATIONPREPARATION DOCUMENTATION REVIEW SCIENTIFIC AND TECHNICALWRITING TRAININGWorkshops and SeminarsWe are able to custom-tailor thefollowing workshops and seminarsat your location: Effective Communications Delegation Coaching and Feedback Developing Associates Setting Performance Standardsand Expectations Effective Meetings Creating a Shared Vision Introduction to Standardization Managing Change Rational Troubleshooting Total Productive MaintenanceOverview Introduction to Total ProductiveMaintenance Total Productive Maintenancein Process Industries Building a ContinuousImprovement Program Building an Effective WorkTeam Conducting PerformanceEvaluations and ReviewsWe believe that people are the key to competition in today’s marketplaceand that training and performance management are the tools that keep thatcompetitive edge sharp.......competence is the prerequisite to competition.......DOCUMENTATIONSERVICESWe are able to provide thefollowing documentationdevelopment services. DOCUMENTATIONASSESSMENT – Analysis ofyour current documentation –provide recommendations forimprovement DOCUMENTATIONPREPARATION DOCUMENTATION REVIEW SCIENTIFIC AND TECHNICALWRITING TRAININGWORKSHOPS ANDSEMINARSWe are able to custom-tailor thefollowing workshops and seminarsat your location: Effective Communications Delegation Coaching and Feedback Developing Associates Setting Performance Standardsand Expectations Effective Meetings Creating a Shared Vision Introduction to Standardization Managing Change Rational Troubleshooting Total Productive MaintenanceOverview Introduction to Total ProductiveMaintenance Total Productive Maintenancein Process Industries Building a ContinuousImprovement Program Building Effective Work Teams Conducting PerformanceEvaluations and Reviews Competency Modeling Performance Analysis Curriculum Design Training Material Development Training Presentation
  14. 14. Copyright © 2013 C. H. Paul Consulting, Inc., Tobyhanna, PA - All Rights Reserved 14C. H. Paul Consulting, Inc.Compliance Supporteeting the requirements of the FDA and other regulatoryagencies is becoming one of the most difficult tasksregulated industries have to face today. Regulatory pressure isincreasing and the penalties for non-compliance have becomemore severe than ever before. At the heart of this issue areStandard Operating Procedures – the most neglected but mostcritical regulatory aspect of running any plant.Our technical writers and analysts are intimately familiar withGood Manufacturing Practices and their requirements for sound,usable, and technically accurate process and operatingdocumentation.We are able to provide a variety of services in this regard fromproducing isolated procedures and fielding teams of technicalwriters to your location to complete significant numbers of theseprocedures, to training your staff to write, evaluate, and approvethese documents.We have also designed a process that effectively enables SOP’s tobe multi-use for regulatory compliance, training, andprocess/production control saving considerable resources andsignificantly reducing the document maintenance burden.MCOMPLIANCE SUPPORTSERVICESWe are able to provide thefollowing compliance supportservices: SOP REVIEW – Review of SOPdocumentation to determinelevel of compliance, technicalaccuracy and completeness, andapplicability for other uses. SOP WRITING WORKSHOPS AND SEMINARS- Standard OperatingProcedures – An overview- Writing Standard OperatingProcedures- Reviewing and ApprovingStandard OperatingProcedures“Current Good Manufacturing Practices have taken onnew significance in this era of multinational suppliers ofpharmaceuticals and foods. Cross-licensing, jointventures, strategic alliances, mergers, acquisitions, anddivestitures underscore the necessity of maintainingstandards of manufacturing and quality control across thegeographical boundary of suppliers and distributors!”……SOP’s that are effectively prepared and applied,bring GMP requirements to the reality of every aspect ofthe production process……
  15. 15. Copyright © 2013 C. H. Paul Consulting, Inc., Tobyhanna, PA - All Rights Reserved 15C. H. Paul Consulting, Inc.Enterprise System Performance Supportt has been our experience that most enterprise system userdocumentation and training fails to achieve its fundamentalpurpose...to make life easy for the user! Failure usually occursafter several million dollars have been spent for the system andmost of the available time before “go-live” has been expended inthe development and customization of the software leaving no timefor substantive end-user training or the preparation of effectiveuser support tools.Failures occur for several reasons:Companies that successfully implement enterprise resourcesystems have realized significant benefits by properly preparingusers to effectively perform their jobs using these integratedsoftware systems as job tools.I Technical writers rather than human performance engineersusually write training and documentation. Technical writers have no idea of how adults learn, how work isperformed, or how the human brain controls the performance ofcomplex tasks. The end products produced consists ofinformation that is not easily accessed, assumes a level of systemknowledge that simply does not exist, and that is organizedaround the command architecture of the software rather thanaround the specific job tasks performed by the user. Documentation is punishing to use, not easily accessed whenneeded, and not easily updated when system changes are made. Training does not properly prepare the user to fully utilize thesystem and the user support tools available.ENTERPRISE SYSTEMSUPPORTWe are able to provide thefollowing enterprise systemperformance support services: BUSINESS PROCESSANALYSIS AND MAPPING –Enterprise systems should onlybe implemented after thebusiness system has beenoptimized. INFORMATIONREQUIREMENTS ANALYSIS –The information needs of eachjob category should drive ERPsystem content and function notsimply what is available fromthe vendor. CHANGE MANAGEMENTSTRATEGIES – The impact ofan ERP system implementationon the workforce can slowforward progress to a crawl ifchange management is notcarefully handled. END-USER TRAINING ANDSUPPORT STRATEGIES –effectively produced ERPdocumentation and training iscritical to a successfulimplementation. TRAINING DELIVERY EXECUTIIVE EDUCATION
  16. 16. Copyright © 2013 C. H. Paul Consulting, Inc., Tobyhanna, PA - All Rights Reserved 16C. H. Paul Consulting, Inc.Our consulting interventions start with senior management as webegin to understand your business strategies and goals. Next, wehelp to redefine your business strategies to optimize all businessprocesses. There is nothing worse than implementing a newsystem to automate a bad process.We basically serve as advocates for your users – the people whowill be using the new ERP system to complete their daily work –from your senior executives to your plant floor workers. Oursolutions transform your business by linking user requirements,your business strategies, priorities and goals, and the new systemtogether into a single cohesive functioning entity.ENTERPRISE END-USERMATERIALS ANDTRAININGThe enterprise end-user materialsand training systems we developare designed to meet the followingrequirements and objectives: Procedures are organizedby job task in a format thatis easy to update as systemchanges occur. Users are able to interactwith the system with littleor no difficulty. The training systemenables users to becomeproficient in system use ina very short period of time Users are able to quicklyaccess infrequently usedinformation in support ofrelevant job tasks User support tools are easilyaccessed through a variety ofmedia.To compete in today’s fast-paced technological society it hasbecome imperative to provide managers and staff with thetools to perform their job functions efficiently and effectively.The time simply is not available to learn .....on-the-job...... Ifpeople are our competitive edge and technology is the toolpeople use in order to compete, then major systems providethe direction and control for the entire process.....people, training, and information.....seed for the future....
  17. 17. Copyright © 2013 C. H. Paul Consulting, Inc., Tobyhanna, PA - All Rights Reserved 17C. H. Paul Consulting, Inc.Performance Manufacturingerformance Manufacturing is a modified lean manufacturingapproach to maximizing the effectiveness of your productionprocesses. It is an interlocking combination of carefully designedprocesses built on a foundation of solid equipment maintenanceachieved through the implementation of Total ProductiveMaintenance Programs.Performance Manufacturing generates “real” processimprovements substantially improving the operationalmeasurements for customer service and quality, equipment andmanpower utilization, downtime, throughput, inventory,changeover time, parts utilization, waste, and rework.We have been implementing Performance Manufacturing systemswithin the fortune 500 since the late 1970’s, long before the terms“Lean Manufacturing” and “Total Productive Maintenance” wereever 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 employeesPERFORMANCEMANUFACTURINGCOMPONENTSOur Performance ManufacturingProcess consists of the followingcomponents and services: REENGINEERING ANDSTANDARDIZATION OFPROCESSES ANDOPERATIONS JOB INSTRUCTIONTRAINING INSPECTION-BASEDTOTAL PRODUCTIVEMAINTENANCESYSTEMS CONTINUOUSIMPROVEMENT CHANGEOVERREDUCTION LOSS ELIMINATION CONTINUOUS FLOWAND WASTEELIMINATION KAIZEN – QUICKIMPROVEMENTS CUSTOM-TAILOREDLEAN MANUFACTURINGTRAINING
  18. 18. Copyright © 2013 C. H. Paul Consulting, Inc., Tobyhanna, PA - All Rights Reserved 18C. H. Paul Consulting, Inc.The Quick Response Performance ManufacturingImprovement ModelTasks Typically Documented Start-up and shutdown procedures Loading materials Operational adjustments Clearing jams Removing, replacing, rebuilding, andadjusting key components Monitoring production Changeover and setup Cleaning Quality checks Preventive maintenance GMPs and SafetyREENGINEER &STANDARDIZEOPERATIONSStandardizing what each worker does is critical toensuring that tasks are performed consistently fromworker to worker across all shifts.Without consistency there is no control. Muchdowntime and waste throughout any manufacturingplant is due to the variation introduced by individualworkers.Without standardization, workers evolve their ownmethods of performing critical tasks, which may ormay not be effective and may even contribute to poorutilization, unscheduled downtime, and catastrophicfailure.JOBPROCEDURETRAININGJob Procedure Training is provided for bothoperators and mechanics.Workers are trained and certified in the use of thechecklists and procedures that are prepared during thestandardization phase of the project. The trainingprogram is customized to each specific job and itemof equipment. The training provides workers withgeneral technical knowledge and specific skills thatare essential to achieving competence in the operationand maintenance of any system.Certification insures that trainees are able to performlearned tasks after training.
  19. 19. Copyright © 2013 C. H. Paul Consulting, Inc., Tobyhanna, PA - All Rights Reserved 19C. H. Paul Consulting, Inc.DIAGNOSTICSTRAININGThe most time critical event in machine maintenanceis troubleshooting equipment problems. To minimizedowntime, it is essential to first rapidly identify majortrouble symptoms and then eliminate them in aprioritized and systematic way.The basic elements of our approach include thefollowing:Task Analysis: “Master Performers” are observed asthey correct malfunctions in order to analyze andcatalog the processes they follow.Prioritizing Tasks: 20% of the problems cause 80%of the downtime. Our approach concentrates on themost frequent and critical malfunctions.Designing Job Aids: Job aids are prepared for eachitem of equipment. They guide mechanics to thelocation of the trouble, indicate the corrective actionto be taken, and specify the parts to be replacedand/or the adjustments to be made.Designing Training: A training program isdeveloped to transfer the skills and techniquesidentified during the task analysis portion of thisphase.Designing Job Certification: Job certification is anon-the-job demonstration of the mechanic’s ability toaccomplish a troubleshooting task.
  20. 20. Copyright © 2013 C. H. Paul Consulting, Inc., Tobyhanna, PA - All Rights Reserved 20C. H. Paul Consulting, Inc.For technology to be effective, it requires a blend of man and machineworking in concert to achieve maximum output. Our firm viewsimproving performance effectiveness by implementing programs thatmaximize the blend of machine, labor, materials, and management.Let our experienced professionals put you on the leading edge oftechnology.........Man and Machine Working Together.........INSPECTION-BASEDMAINTENANCEMost approaches to equipment maintenance arereactive at best with workers responding to failureonly after equipment has ceased functioning – “fix itwhen it breaks.” Production equipment is the heartof the manufacturing process. If it doesn’t run youdon’t make product. If it doesn’t run well, you can’tmeet your commitments and productionrequirements.The answer is to implement an inspection-basedmaintenance system in which everyone in the plantparticipates from custodian to equipment mechanic –“maintain it so it never breaks.”The three major causes of malfunction in anymachine system are dirt/contamination, loose ormissing fasteners that create vibration, misalignment,catastrophic failure, and lack of lubrication. Theprocess empowers workers with the responsibility ofmaximizing equipment operation, effectiveness, andmaintainability by: Inspecting equipment on a periodic basisthroughout 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 toimprove maintainabilityA detailed Machine Analysis is conducted todetermine the specific inspection, lubrication,cleaning, and preventive maintenance requirementsthat must be met in order to assure maximumeffectiveness. A training program is designed andpresented that provides the skills workers need toutilize all facets and components of the system.Key Components Determining equipmenteffectiveness Six losses elimination Establish basicequipment conditions Prepare daily inspections Standardize maintenanceactivities Maintenance planning Lubrication control Maintenance prevention Kaizen
  21. 21. Copyright © 2013 C. H. Paul Consulting, Inc., Tobyhanna, PA - All Rights Reserved 21C. H. Paul Consulting, Inc.Training Capability Buildinghe highly technical and fast-paced world of todays workerrequires that complex tasks and job activities be masteredquickly and be performed with great accuracy. To compound theserequirements, workers are increasingly being organized into workteams or work groups with the responsibility of training/cross-training their peers in new job activities and tasks. Traditionalclassroom training methods that were sufficient to train the workerof yesterday simply cant guarantee consistent standardizedperformance to meet todays needs. Using outside trainingresources may no longer be a viable alternative to meeting internaltraining requirements. Companies are operating "lean and mean"without the staffing flexibility to hire permanent trainingprofessionals.Our Building Training Capability Program is a combination ofconsulting interventions, consulting projects, and trainingworkshops that creates an internal training function within thefacility, specifies the training that needs to be accomplished, andforms and trains a training team.Job/Task AnalysisThe Job/Task Analysis is a three-step process. During the first step,Develop and Validate Task Listing, a valid list of tasks isdeveloped for each job function. This step defines the scope orboundary conditions of the task analysis and focuses and controlsactual analysis activities such as scheduling interviews, and thereview of relevant supporting information.During the second step, Analyze Each Individual Task, each task isanalyzed to determine those characteristics that influence trainingdesign and planning.During the third step of this process, Develop PerformanceObjectives, behavioral objectives are developed for each taskanalyzed. Performance objectives specify what the learner willaccomplish as a result of having received the instruction.TTRAINING CAPABILITYBUILDINGOur Training Capability BuildingProcess consists of the followingcomponents and services: The development of adetailed job analysis for eachfunction and job position toserve as a basis for a plant-wide training plan, trainingcurriculum, and certificationprogram. The development of a jobspecific training design andtraining plan that details thetraining each job incumbentmust complete in order to bequalified and certified in theposition. The development of atraining curriculum thatspecifies courses for eachjob position, training content,training modules, trainingmaterials, training times, andtraining requirements. The development of aperformance-based jobcertification program thatobjectively assesses aworkers level of jobcompetency before and aftertraining. The establishment of atraining team. Teammembers are trained intraining development, needsassessment, training analysis,preparation and presentationskills, coaching for improvedwork performance, and theskills required to conduct acertification program. Three consultant audits oftraining conducted everythree months for one yearafter the completion of theproject.
  22. 22. Copyright © 2013 C. H. Paul Consulting, Inc., Tobyhanna, PA - All Rights Reserved 22C. H. Paul Consulting, Inc.Training Design, Training Plan and Training CurriculumOnce the Job/Task Analysis has been completed, it is then possibleto begin curriculum planning for each of the learner’s jobfunctions. The task data generated for the Job/Task Analysisprovides the supporting information for the preparationcomponent. The curriculum specifies the training sequence, thecommercially available training materials that should bepurchased, a detailed design of all custom-designed materials thatshould be prepared to enhance and integrate the various materialsinto a cohesive training program, coordination with vocationalschools and community colleges to provide any needed relevantinstruction, and a detailed implementation plan for all aspects ofthe instructional program.Certification ProgramJob Certification is a performance-based procedure designed toinsure that all workers are able to successfully perform the taskscomprising their job. The certification process, administered beforeundertaking training, provides a performance baseline againstwhich all training skill gains can be measured. After training, theadministration of the certification process provides a basis formeasuring mastery of learned skills and any requirements forremedial training.Trainer Training ProgramThe Trainer Training Program is designed to be presented to non-professional trainers who have extensive experience in their fieldor craft but have little or no formal experience presenting training.Participants must demonstrate competence at the end of theworkshop by developing and preparing a simple training programutilizing all of the skills mastered. Trainees are evaluated andcertified as trainers at the completion of the program. Theconsultant support time after the completion of training is used toevaluate instructors on a periodic basis and to provide support andassistance where needed to insure that a minimum standard isbeing maintained.PROGRAM BENEFITS A formalized trainingcurriculum prepared and usedas a guide in the administrationof job specific training. A trained and certified trainingteam functioning from within thefacility. Company training and cross-training needs satisfiedeconomically and effectively. Training is performance-basedwith a certification element toinsure individual success. Job performance improvedthroughout the facility.“Provide individuals with a fish and they will be able to eat for today, teachthose same individuals to fish and they will be able to eat for a lifetime.”..…the only answer to the training of todays workforce is self-sufficiency……
  23. 23. Copyright © 2013 C. H. Paul Consulting, Inc., Tobyhanna, PA - All Rights Reserved 23C. H. Paul Consulting, Inc.Management/Leadership Developmentrganizations like people sometimes fall short of realizingtheir full potential and achieving their goals. Obsolete ideas,lack of proper focus, direction and trust, cumbersome managementstructures, lack of effective performance management, inability toretain key employees, and the lack of teamwork, all seriouslyhinder forward progress and threaten the competitive edge.Organizational development is defined as the planned,organization-wide effort to increase an organization’s effectivenessby improving the processes that define it.Through the implementation of our approach our clients have beenable to:To be effective, management training must be directly relevant tothe participant’s job, working environment, and corporate visionand goals. Most management training programs fail because theyare simply too generic to have any real meaning for the participant.After training, participants are expected to transfer the genericskills and knowledge they have learned to their actual job. A verydifficult feat for even the most sophisticated!Our approach is to develop management training that is specific tothe job, reflects the corporate culture and vision, and addresses theproblems 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, andinnovation. Improve operational and administrative processes Improve manager to manager and manager to laborcommunication and trust Build leaders that are capable of leading the organization togreater market position and growthMGT & LEADERSHIPDEVELOPMENTOur Management/LeadershipDevelopment Process consists of thefollowing components and services: JOB/TASK ANALYSIS &DESIGN PERFORMANCE ANALYSIS OPERATIONAL STUDIES REENGINEERING SKILLS ASSESSMENT MANAGEMENT TRAININGDYNAMICS OF LEADERSHIPLevel 1: Managing Your RelationshipsCreating a Shared VisionCommunicating Effectively withProduction Team MembersGiving Clear and UnbiasedInformation on the ManufacturingFloorWorking with Customers and SuppliersImpacting the Manufacturing ProcessLevel 2: Managing Your JobMaximizing Management TimeIdentifying and Solving ManufacturingProblemsMaking Manufacturing Decisions andWeighing RiskBuilding a Continuous ImprovementProgramEffective Equipment Operation in the21stCentury PlantLevel 3: Managing OthersTraining the Production TeamProviding Coaching & Feedback toProduction Team MembersDiscipline & Counseling within theManufacturing EnvironmentLeading Effectively in a ChaoticEnvironment
  24. 24. Copyright © 2013 C. H. Paul Consulting, Inc., Tobyhanna, PA - All Rights Reserved 24C. H. Paul Consulting, Inc.Another reason why management training fails is because it doesnot have the support of senior management. Our approachinvolves senior management at every level of the process – design,development, and program implementation.Our development process consists of five key phases.Management Development ModelResearch&DesignAchieveBuy-inDevelopCoreModulesModulesSelf-StudyMentorMeetingsWorkshops RealDeliverables Phase I – Research and Design Phase II – Achieve Buy-In Phase III – Develop Core Modules Phase IV – Implementation Phase V – Transfer SkillsDEVELOPMENT PROCESS Phase I – Research & DesignUnderstand core issuesConduct assessmentCompile informationDetermine job requirementsDesign the curriculumGather relevant information Phase II – Achieve Buy-inGain “buy-in” from stakeholdersSeek agreement – curriculumand instructional approachAdvertise the program –expectations, benefits, andexpected results Phase III – Develop ModulesCreate personalized coremodules that support completionof “real” deliverablesDetermine delivery method(s)Conduct pilot training and revisethe programDevelop Mentoring Programand select mentors Phase IV – ImplementationTrain corporate trainersTrain mentorsDevelop training planSupport trainers Phase V – Transfer SkillsConduct post trainingassessmentMonitor mentor meetingactivitiesConsult with senior managementMonitor performance
  25. 25. Copyright © 2013 C. H. Paul Consulting, Inc., Tobyhanna, PA - All Rights Reserved 25C. H. Paul Consulting, Inc.What Are Some Specific Examples?esigned a management leadership-training program for a major distributor of retailfoods. Trained over 200 instructors to administer the program throughout theUnited States.Developed system documentation and user training for a corporate-wide enterprisemanagement system. The $25,000,000.00 system addressed virtually all of thecorporation’s functional areas. The implementation required almost fourteen months ofmaterial development and training preparation.Designed a company-wide self-directed work team program and implementation plan fora major pharmaceutical manufacturer. The five-year implementation plan addressedissues of manpower, system optimization, training, and team responsibility.Designed a leadership development curriculum for pharmaceutical operations consistingof ten custom-designed and company specific workshops covering skill deficienciesuncovered during a corporate-wide assessment. Trained corporate trainers to administerthe program at all plant locations.Established an internal plant technical training function for a major manufacturer ofcosmetics and hair-care products. Performed a detailed job/task analysis to support theirpay-for-skills program, developed a plant-wide technical training curriculum, establishedand trained a technical training work cell, and monitored operations until expectationswere met.Assisted a major manufacturer of pharmaceuticals to consolidate the manufacturingoperations of three plants into a new fourth location. Developed and implementedstandardized manufacturing methods, technical worker training, and preventivemaintenance systems for all installed manufacturing equipment. The project alsoconsisted of analyzing manufacturing and training functions at four plants in threeEuropean countries.D
  26. 26. Copyright © 2013 C. H. Paul Consulting, Inc., Tobyhanna, PA - All Rights Reserved 26C. H. Paul Consulting, Inc.Assisted a major manufacturer of pharmaceuticals to consolidate the manufacturingoperations of three plants into a new fourth location. Developed and implementedstandardized manufacturing methods, technical worker training, and preventivemaintenance systems for all installed manufacturing equipment. The project alsoconsisted of analyzing manufacturing and training functions at four plants in threeEuropean 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 RoadHamilton Square, NJ 08690609-587-8358(F) 609-587-1423cpaul19436@aol.comC

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