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ISO 14644 A Complete Guide - 2020 Edition

ISO 14644 A Complete Guide - 2020 Edition

Автором Gerardus Blokdyk

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ISO 14644 A Complete Guide - 2020 Edition

Автором Gerardus Blokdyk

Длина:
317 pages
1 hour
Издатель:
Издано:
Sep 5, 2019
ISBN:
9780655963004
Формат:
Книге

Описание

Do you have an existing cleanroom? If required, how is pressure inside a room increased? Are bait stations robust, of tamper resistant construction, secured in place and appropriately located to prevent any contamination risk to product? What are the different models require for cleanroom software engineering certification? What is the Minimum / Maximum / Recommended Flow Rate specified in Cleanroom Standards?

This instant ISO 14644 self-assessment will make you the dependable ISO 14644 domain leader by revealing just what you need to know to be fluent and ready for any ISO 14644 challenge.

How do I reduce the effort in the ISO 14644 work to be done to get problems solved? How can I ensure that plans of action include every ISO 14644 task and that every ISO 14644 outcome is in place? How will I save time investigating strategic and tactical options and ensuring ISO 14644 costs are low? How can I deliver tailored ISO 14644 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 ISO 14644 essentials are covered, from every angle: the ISO 14644 self-assessment shows succinctly and clearly that what needs to be clarified to organize the required activities and processes so that ISO 14644 outcomes are achieved.

Contains extensive criteria grounded in past and current successful projects and activities by experienced ISO 14644 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 ISO 14644 are maximized with professional results.

Your purchase includes access details to the ISO 14644 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 ISO 14644 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.

Издатель:
Издано:
Sep 5, 2019
ISBN:
9780655963004
Формат:
Книге

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ISO 14644 A Complete Guide - 2020 Edition - Gerardus Blokdyk

ISO 14644

Complete Self-Assessment Guide

The guidance in this Self-Assessment is based on ISO 14644 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

service@theartofservice.com

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

service@theartofservice.com

Included Resources - how to access

Included with your purchase of the book is the ISO 14644 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

access@theartofservice.com

with this books’ title in the subject to get the ISO 14644 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 access@theartofservice.com with this books’ title in the subject to get the ISO 14644 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 ISO 14644, 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 ISO 14644 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 ISO 14644, 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 ISO 14644 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 ISO 14644 Scorecard on the second next page of the Self-Assessment.

Your completed ISO 14644 Scorecard will give you a clear presentation of which ISO 14644 areas need attention.

ISO 14644

Scorecard Example

Example of how the finalized Scorecard can look like:

ISO 14644

Scorecard

Your Scores:

BEGINNING OF THE

SELF-ASSESSMENT:

Table of Contents

About The Art of Service10

Included Resources - how to access10

Purpose of this Self-Assessment12

How to use the Self-Assessment13

ISO 14644

Scorecard Example15

ISO 14644

Scorecard16

BEGINNING OF THE

SELF-ASSESSMENT:17

CRITERION #1: RECOGNIZE18

CRITERION #2: DEFINE:30

CRITERION #3: MEASURE:44

CRITERION #4: ANALYZE:56

CRITERION #5: IMPROVE:67

CRITERION #6: CONTROL:83

CRITERION #7: SUSTAIN:96

ISO 14644 and Managing Projects, Criteria for Project Managers:137

1.0 Initiating Process Group: ISO 14644138

1.1 Project Charter: ISO 14644140

1.2 Stakeholder Register: ISO 14644142

1.3 Stakeholder Analysis Matrix: ISO 14644143

2.0 Planning Process Group: ISO 14644145

2.1 Project Management Plan: ISO 14644147

2.2 Scope Management Plan: ISO 14644149

2.3 Requirements Management Plan: ISO 14644151

2.4 Requirements Documentation: ISO 14644153

2.5 Requirements Traceability Matrix: ISO 14644155

2.6 Project Scope Statement: ISO 14644157

2.7 Assumption and Constraint Log: ISO 14644159

2.8 Work Breakdown Structure: ISO 14644161

2.9 WBS Dictionary: ISO 14644163

2.10 Schedule Management Plan: ISO 14644165

2.11 Activity List: ISO 14644167

2.12 Activity Attributes: ISO 14644169

2.13 Milestone List: ISO 14644171

2.14 Network Diagram: ISO 14644173

2.15 Activity Resource Requirements: ISO 14644175

2.16 Resource Breakdown Structure: ISO 14644176

2.17 Activity Duration Estimates: ISO 14644178

2.18 Duration Estimating Worksheet: ISO 14644180

2.19 Project Schedule: ISO 14644182

2.20 Cost Management Plan: ISO 14644184

2.21 Activity Cost Estimates: ISO 14644186

2.22 Cost Estimating Worksheet: ISO 14644188

2.23 Cost Baseline: ISO 14644190

2.24 Quality Management Plan: ISO 14644192

2.25 Quality Metrics: ISO 14644194

2.26 Process Improvement Plan: ISO 14644196

2.27 Responsibility Assignment Matrix: ISO 14644198

2.28 Roles and Responsibilities: ISO 14644200

2.29 Human Resource Management Plan: ISO 14644202

2.30 Communications Management Plan: ISO 14644204

2.31 Risk Management Plan: ISO 14644206

2.32 Risk Register: ISO 14644208

2.33 Probability and Impact Assessment: ISO 14644210

2.34 Probability and Impact Matrix: ISO 14644212

2.35 Risk Data Sheet: ISO 14644214

2.36 Procurement Management Plan: ISO 14644216

2.37 Source Selection Criteria: ISO 14644218

2.38 Stakeholder Management Plan: ISO 14644220

2.39 Change Management Plan: ISO 14644222

3.0 Executing Process Group: ISO 14644224

3.1 Team Member Status Report: ISO 14644226

3.2 Change Request: ISO 14644228

3.3 Change Log: ISO 14644230

3.4 Decision Log: ISO 14644232

3.5 Quality Audit: ISO 14644234

3.6 Team Directory: ISO 14644236

3.7 Team Operating Agreement: ISO 14644238

3.8 Team Performance Assessment: ISO 14644240

3.9 Team Member Performance Assessment: ISO 14644242

3.10 Issue Log: ISO 14644244

4.0 Monitoring and Controlling Process Group: ISO 14644246

4.1 Project Performance Report: ISO 14644248

4.2 Variance Analysis: ISO 14644250

4.3 Earned Value Status: ISO 14644252

4.4 Risk Audit: ISO 14644254

4.5 Contractor Status Report: ISO 14644256

4.6 Formal Acceptance: ISO 14644258

5.0 Closing Process Group: ISO 14644260

5.1 Procurement Audit: ISO 14644262

5.2 Contract Close-Out: ISO 14644264

5.3 Project or Phase Close-Out: ISO 14644266

5.4 Lessons Learned: ISO 14644268

ISO 14644 and Managing Projects, Criteria for Project Managers:270

1.0 Initiating Process Group: ISO 14644271

1.1 Project Charter: ISO 14644273

1.2 Stakeholder Register: ISO 14644275

1.3 Stakeholder Analysis Matrix: ISO 14644276

2.0 Planning Process Group: ISO 14644278

2.1 Project Management Plan: ISO 14644280

2.2 Scope Management Plan: ISO 14644282

2.3 Requirements Management Plan: ISO 14644284

2.4 Requirements Documentation: ISO 14644286

2.5 Requirements Traceability Matrix: ISO 14644288

2.6 Project Scope Statement: ISO 14644290

2.7 Assumption and Constraint Log: ISO 14644292

2.8 Work Breakdown Structure: ISO 14644294

2.9 WBS Dictionary: ISO 14644296

2.10 Schedule Management Plan: ISO 14644298

2.11 Activity List: ISO 14644300

2.12 Activity Attributes: ISO 14644302

2.13 Milestone List: ISO 14644304

2.14 Network Diagram: ISO 14644306

2.15 Activity Resource Requirements: ISO 14644308

2.16 Resource Breakdown Structure: ISO 14644310

2.17 Activity Duration Estimates: ISO 14644312

2.18 Duration Estimating Worksheet: ISO 14644314

2.19 Project Schedule: ISO 14644316

2.20 Cost Management Plan: ISO 14644318

2.21 Activity Cost Estimates: ISO 14644320

2.22 Cost Estimating Worksheet: ISO 14644322

2.23 Cost Baseline: ISO 14644324

2.24 Quality Management Plan: ISO 14644326

2.25 Quality Metrics: ISO 14644328

2.26 Process Improvement Plan: ISO 14644330

2.27 Responsibility Assignment Matrix: ISO 14644332

2.28 Roles and Responsibilities: ISO 14644334

2.29 Human Resource Management Plan: ISO 14644336

2.30 Communications Management Plan: ISO 14644338

2.31 Risk Management Plan: ISO 14644340

2.32 Risk Register: ISO 14644342

2.33 Probability and Impact Assessment: ISO 14644344

2.34 Probability and Impact Matrix: ISO 14644346

2.35 Risk Data Sheet: ISO 14644348

2.36 Procurement Management Plan: ISO 14644350

2.37 Source Selection Criteria: ISO 14644352

2.38 Stakeholder Management Plan: ISO 14644354

2.39 Change Management Plan: ISO 14644356

3.0 Executing Process Group: ISO 14644358

3.1 Team Member Status Report: ISO 14644360

3.2 Change Request: ISO 14644362

3.3 Change Log: ISO 14644364

3.4 Decision Log: ISO 14644366

3.5 Quality Audit: ISO 14644368

3.6 Team Directory: ISO 14644370

3.7 Team Operating Agreement: ISO 14644372

3.8 Team Performance Assessment: ISO 14644374

3.9 Team Member Performance Assessment: ISO 14644376

3.10 Issue Log: ISO 14644378

4.0 Monitoring and Controlling Process Group: ISO 14644380

4.1 Project Performance Report: ISO 14644382

4.2 Variance Analysis: ISO 14644384

4.3 Earned Value Status: ISO 14644386

4.4 Risk Audit: ISO 14644388

4.5 Contractor Status Report: ISO 14644390

4.6 Formal Acceptance: ISO 14644392

5.0 Closing Process Group: ISO 14644394

5.1 Procurement Audit: ISO 14644395

5.2 Contract Close-Out: ISO 14644397

5.3 Project or Phase Close-Out: ISO 14644399

5.4 Lessons Learned: ISO 14644401

Index403

CRITERION #1: RECOGNIZE

INTENT: Be aware of the need for change. Recognize that there is an unfavorable variation, problem or symptom.

In my belief, the answer to this question is clearly defined:

5 Strongly Agree

4 Agree

3 Neutral

2 Disagree

1 Strongly Disagree

1. Are product contact liners (or raw material work-in-progress contact liners) purchased by your organization, appropriately coloured and resistant to tearing to prevent accidental contamination?

<--- Score

2. How does cleanroom meet owners needs and mission?

<--- Score

3. What procedure will be used to prevent the Cathodic Protection Well (CPW) from providing an avenue to contamination during construction (if applicable)?

<--- Score

4. What air exchange rate is needed?

<--- Score

5. What situation(s) led to this ISO 14644 Self Assessment?

<--- Score

6. Are there any specific expectations or concerns

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