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    Process Validation A Complete Guide - 2020 Edition
    Process Validation A Complete Guide - 2020 Edition
    Process Validation A Complete Guide - 2020 Edition
    Ebook213 pages1 hour

    Process Validation A Complete Guide - 2020 Edition

    By Gerardus Blokdyk

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    About this ebook

    When you perform a process validation, should the equipment instruments be calibrated immediately after the completion of the validation runs? How are process validation and qms addressed? Will the quality agreement cover one or multiple projects? Why do you apply a risk-based approach to process validation? Is the data properly tabulated and summarized?

    This valuable Process Validation self-assessment will make you the credible Process Validation domain authority by revealing just what you need to know to be fluent and ready for any Process Validation challenge.

    How do I reduce the effort in the Process Validation work to be done to get problems solved? How can I ensure that plans of action include every Process Validation task and that every Process Validation outcome is in place? How will I save time investigating strategic and tactical options and ensuring Process Validation costs are low? How can I deliver tailored Process Validation advice instantly with structured going-forward plans?

    There’s no better guide through these mind-expanding questions than acclaimed best-selling author Gerard Blokdyk. Blokdyk ensures all Process Validation essentials are covered, from every angle: the Process Validation self-assessment shows succinctly and clearly that what needs to be clarified to organize the required activities and processes so that Process Validation outcomes are achieved.

    Contains extensive criteria grounded in past and current successful projects and activities by experienced Process Validation practitioners. Their mastery, combined with the easy elegance of the self-assessment, provides its superior value to you in knowing how to ensure the outcome of any efforts in Process Validation are maximized with professional results.

    Your purchase includes access details to the Process Validation self-assessment dashboard download which gives you your dynamically prioritized projects-ready tool and shows you exactly what to do next. Your exclusive instant access details can be found in your book. You will receive the following contents with New and Updated specific criteria:

    - The latest quick edition of the book in PDF

    - The latest complete edition of the book in PDF, which criteria correspond to the criteria in...

    - The Self-Assessment Excel Dashboard

    - Example pre-filled Self-Assessment Excel Dashboard to get familiar with results generation

    - In-depth and specific Process Validation Checklists

    - Project management checklists and templates to assist with implementation

    INCLUDES LIFETIME SELF ASSESSMENT UPDATES

    Every self assessment comes with Lifetime Updates and Lifetime Free Updated Books. Lifetime Updates is an industry-first feature which allows you to receive verified self assessment updates, ensuring you always have the most accurate information at your fingertips.

    LanguageEnglish
    Publisher5STARCooks
    Release dateMar 1, 2020
    ISBN9781867386964
    Process Validation A Complete Guide - 2020 Edition

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      Book preview

      Process Validation A Complete Guide - 2020 Edition - Gerardus Blokdyk

      Process Validation

      Complete Self-Assessment Guide

      The guidance in this Self-Assessment is based on Process Validation best practices and standards in business process architecture, design and quality management. The guidance is also based on the professional judgment of the individual collaborators listed in the Acknowledgments.

      Notice of rights

      You are licensed to use the Self-Assessment contents in your presentations and materials for internal use and customers without asking us - we are here to help.

      All rights reserved for the book itself: this book may not be reproduced or transmitted in any form by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written permission of the publisher.

      The information in this book is distributed on an As Is basis without warranty. While every precaution has been taken in the preparation of he book, neither the author nor the publisher shall have any liability to any person or entity with respect to any loss or damage caused or alleged to be caused directly or indirectly by the instructions contained in this book or by the products described in it.

      Trademarks

      Many of the designations used by manufacturers and sellers to distinguish their products are claimed as trademarks. Where those designations appear in this book, and the publisher was aware of a trademark claim, the designations appear as requested by the owner of the trademark. All other product names and services identified throughout this book are used in editorial fashion only and for the benefit of such companies with no intention of infringement of the trademark. No such use, or the use of any trade name, is intended to convey endorsement or other affiliation with this book.

      Copyright © by The Art of Service

      http://theartofservice.com

      [email protected]

      About The Art of Service

      The Art of Service, Business Process Architects since 2000, is dedicated to helping stakeholders achieve excellence.

      Defining, designing, creating, and implementing a process to solve a stakeholders challenge or meet an objective is the most valuable role… In EVERY group, company, organization and department.

      Unless you’re talking a one-time, single-use project, there should be a process. Whether that process is managed and implemented by humans, AI, or a combination of the two, it needs to be designed by someone with a complex enough perspective to ask the right questions.

      Someone capable of asking the right questions and step back and say, ‘What are we really trying to accomplish here? And is there a different way to look at it?’

      With The Art of Service’s Standard Requirements Self-Assessments, we empower people who can do just that — whether their title is marketer, entrepreneur, manager, salesperson, consultant, Business Process Manager, executive assistant, IT Manager, CIO etc... —they are the people who rule the future. They are people who watch the process as it happens, and ask the right questions to make the process work better.

      Contact us when you need any support with this Self-Assessment and any help with templates, blue-prints and examples of standard documents you might need:

      http://theartofservice.com

      [email protected]

      Included Resources - how to access

      Included with your purchase of the book is the Process Validation Self-Assessment Spreadsheet Dashboard which contains all questions and Self-Assessment areas and auto-generates insights, graphs, and project RACI planning - all with examples to get you started right away.

      How? Simply send an email to

      [email protected]

      with this books’ title in the subject to get the Process Validation Self Assessment Tool right away.

      You will receive the following contents with New and Updated specific criteria:

      •The latest quick edition of the book in PDF

      •The latest complete edition of the book in PDF, which criteria correspond to the criteria in...

      •The Self-Assessment Excel Dashboard, and...

      •Example pre-filled Self-Assessment Excel Dashboard to get familiar with results generation

      •In-depth specific Checklists covering the topic

      •Project management checklists and templates to assist with implementation

      INCLUDES LIFETIME SELF ASSESSMENT UPDATES

      Every self assessment comes with Lifetime Updates and Lifetime Free Updated Books. Lifetime Updates is an industry-first feature which allows you to receive verified self assessment updates, ensuring you always have the most accurate information at your fingertips.

      Get it now- you will be glad you did - do it now, before you forget.

      Send an email to [email protected] with this books’ title in the subject to get the Process Validation Self Assessment Tool right away.

      Purpose of this Self-Assessment

      This Self-Assessment has been developed to improve understanding of the requirements and elements of Process Validation, based on best practices and standards in business process architecture, design and quality management.

      It is designed to allow for a rapid Self-Assessment to determine how closely existing management practices and procedures correspond to the elements of the Self-Assessment.

      The criteria of requirements and elements of Process Validation have been rephrased in the format of a Self-Assessment questionnaire, with a seven-criterion scoring system, as explained in this document.

      In this format, even with limited background knowledge of Process Validation, a manager can quickly review existing operations to determine how they measure up to the standards. This in turn can serve as the starting point of a ‘gap analysis’ to identify management tools or system elements that might usefully be implemented in the organization to help improve overall performance.

      How to use the Self-Assessment

      On the following pages are a series of questions to identify to what extent your Process Validation initiative is complete in comparison to the requirements set in standards.

      To facilitate answering the questions, there is a space in front of each question to enter a score on a scale of ‘1’ to ‘5’.

      1 Strongly Disagree

      2 Disagree

      3 Neutral

      4 Agree

      5 Strongly Agree

      Read the question and rate it with the following in front of mind:

      ‘In my belief,

      the answer to this question is clearly defined’.

      There are two ways in which you can choose to interpret this statement;

      1.how aware are you that the answer to the question is clearly defined

      2.for more in-depth analysis you can choose to gather evidence and confirm the answer to the question. This obviously will take more time, most Self-Assessment users opt for the first way to interpret the question and dig deeper later on based on the outcome of the overall Self-Assessment.

      A score of ‘1’ would mean that the answer is not clear at all, where a ‘5’ would mean the answer is crystal clear and defined. Leave emtpy when the question is not applicable or you don’t want to answer it, you can skip it without affecting your score. Write your score in the space provided.

      After you have responded to all the appropriate statements in each section, compute your average score for that section, using the formula provided, and round to the nearest tenth. Then transfer to the corresponding spoke in the Process Validation Scorecard on the second next page of the Self-Assessment.

      Your completed Process Validation Scorecard will give you a clear presentation of which Process Validation areas need attention.

      Process Validation

      Scorecard Example

      Example of how the finalized Scorecard can look like:

      Process Validation

      Scorecard

      Your Scores:

      BEGINNING OF THE

      SELF-ASSESSMENT:

      Table of Contents

      About The Art of Service7

      Included Resources - how to access7

      Purpose of this Self-Assessment9

      How to use the Self-Assessment10

      Process Validation

      Scorecard Example12

      Process Validation

      Scorecard13

      BEGINNING OF THE

      SELF-ASSESSMENT:14

      CRITERION #1: RECOGNIZE15

      CRITERION #2: DEFINE:26

      CRITERION #3: MEASURE:41

      CRITERION #4: ANALYZE:55

      CRITERION #5: IMPROVE:72

      CRITERION #6: CONTROL:88

      CRITERION #7: SUSTAIN:100

      Process Validation and Managing Projects, Criteria for Project Managers:125

      1.0 Initiating Process Group: Process Validation126

      1.1 Project Charter: Process Validation128

      1.2 Stakeholder Register: Process Validation130

      1.3 Stakeholder Analysis Matrix: Process Validation131

      2.0 Planning Process Group: Process Validation133

      2.1 Project Management Plan: Process Validation135

      2.2 Scope Management Plan: Process Validation137

      2.3 Requirements Management Plan: Process Validation139

      2.4 Requirements Documentation: Process Validation142

      2.5 Requirements Traceability Matrix: Process Validation144

      2.6 Project Scope Statement: Process Validation146

      2.7 Assumption and Constraint Log: Process Validation148

      2.8 Work Breakdown Structure: Process Validation150

      2.9 WBS Dictionary: Process Validation152

      2.10 Schedule Management Plan: Process Validation155

      2.11 Activity List: Process Validation157

      2.12 Activity Attributes: Process Validation159

      2.13 Milestone List: Process Validation161

      2.14 Network Diagram: Process Validation163

      2.15 Activity Resource Requirements: Process Validation165

      2.16 Resource Breakdown Structure: Process Validation166

      2.17 Activity Duration Estimates: Process Validation168

      2.18 Duration Estimating Worksheet: Process Validation170

      2.19 Project Schedule: Process Validation172

      2.20 Cost Management Plan: Process Validation174

      2.21 Activity Cost Estimates: Process Validation176

      2.22 Cost Estimating Worksheet: Process Validation178

      2.23 Cost Baseline: Process

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