Get Excellent Performance. Good Engineering Practice Howard Sneider, CPIP Process, CRB. Agenda

Transcription

1 Get Excellent Performance from Good Engineering Practice Howard Sneider, CPIP Process, CRB Agenda Part 1: Engineering Practice good engineering practice Part 2: Good Engineering Practice Part 3: Getting Alignment 1

2 What is an Engineer? The scientist seeks to understand what is; the engineer seeks to create what never was Theodore von Kármán The Consultant s Job Understand the Client s Needs 2

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4 The Consultant s Job Understand the Client s Needs odesign Constraints odesign Assumptions odesign Loads 4

5 Modernity, Risk and Safety Risk Safety Factor Legacy State of the art Existing Modernity Novel 5

6 The Engineering Method Define the Problem Do Background Research Specify the Requirements Conceptual Design Detailed Design Bidding Construction Administration Consider Options Develop Solution Test Solution Meets All Requirements Repeat as Needed The Consultant s Job Communicate those needs by generating documents a contractor/fabricator can understand to design and construct the required equipment and facility. 6

7 The Engineering Product Conceptual Value Detailed Value 7

8 Product Knowledge Good Engineering Practice Process Knowledge Regulatory Requirements Company Quality Req s Risk Management Design Review Change Management Good Engineering Practice is defined as those established engineering methods and standards that are applied throughout the life cycle to deliver appropriate and effective solutions Examples of Good Engineering Practices include: Specification, design, and installation activities should take full account of all applicable requirements, including GxP, safety, health, environmental, ergonomic, operational, maintenance, recognized industry standards, and other statutory requirements Adequate provisions related to quality should be included in specification, design, procurement, and other contractual documents Life cycle documentation covering planning, specification, design, verification, installation, acceptance, and maintenance should be produced An appropriate degree of oversight and control should be achieved by suitable verification of execution, construction and installation activities. 8

9 deliver appropriate and Good Engineering Practice is defined as those established engineering methods and standards that are applied throughout the life cycle to deliver appropriate and effective solutions. effective solutions Examples of Good Engineering Practices include: take Specification, full design, account and installation of all activities should take full account of all applicable requirements, including applicable GxP, safety, requirements health, environmental, ergonomic, operational, maintenance, recognized industry standards, and other statutory requirements Adequate provisions related to quality should be included quality in specification, should design, procurement, be included and other contractual documents. Life cycle documentation covering planning, specification, design, verification, installation, acceptance, and maintenance should should be produced. be An appropriate degree of oversight and control should be verification achieved by suitable verification of activities. execution, construction and installation activities. User Requirement Brief Executive Summary o Automation Strategy o Purpose o Level of Automation o Project Rationale and Background o Conceptual System Architecture o Goals and Priorities Business Systems o Scope Overview o ERP Capacity o Batch Records o Capacity Requirements and Basis o DMS o Process Design Basis o LIMS o Flexibility o Maintenance Systems o Plant Capacity and Batch Sizes o EDMS o Expandability/Phasing Strategy o Other Systems o Capacity Utilization Targets Validation o Yield Targets o Validation Involvement and o Modeling Responsibilities Operational Strategies o General Approach o General o Validation of Automation o Manufacturing Plant Configuration Cost o Maintenance and Reliability o Capital Cost o Staffing o Cost of Production o Production Support Services Revision History Automation and Controls 9

10 Engineering Change Management Documentation Review Design Risk Assessment Work Flow Management Design Review Automation Reviews 10

11 Lessons Learned Should be Learned NOW Todd Siler 11