ISO 14644 Toolkit

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Save time, empower your teams and effectively upgrade your processes with access to this practical ISO 14644 Toolkit and guide. Address common challenges with best-practice templates, step-by-step work plans and maturity diagnostics for any ISO 14644 related project.

Download the Toolkit and in Three Steps you will be guided from idea to implementation results.

The Toolkit contains the following practical and powerful enablers with new and updated ISO 14644 specific requirements:


STEP 1: Get your bearings

Start with...

  • The latest quick edition of the ISO 14644 Self Assessment book in PDF containing 49 requirements to perform a quickscan, get an overview and share with stakeholders.

Organized in a data driven improvement cycle RDMAICS (Recognize, Define, Measure, Analyze, Improve, Control and Sustain), check the…

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

Then find your goals...


STEP 2: Set concrete goals, tasks, dates and numbers you can track

Featuring 997 new and updated case-based questions, organized into seven core areas of process design, this Self-Assessment will help you identify areas in which ISO 14644 improvements can be made.

Examples; 10 of the 997 standard requirements:

  1. Does your organization have a procedure for handling, transport, storage, use and planned maintenance of equipment in order to ensure proper functioning and to prevent contamination or deterioration?

  2. Are previous uses of it known and are any of the already stated former uses associated with a high risk of potential contamination that will impact on cost and timelines for any planned development?

  3. Are spill prevention control and countermeasures plans required to reduce the likelihood of contaminants escaping from confined areas and to specify procedures for cleaning up contaminated soil?

  4. Is the lab designed with a ducted air ventilation system that provides sustained directional airflow by drawing air into your organization from clean areas toward potentially contaminated areas?

  5. 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?

  6. Has your organization established, implemented and maintained Pre-requisite Programs to assist in controlling cross-contamination risks by physical, chemical and microbiological hazards?

  7. Does your organization undertake a documented assessment of the security arrangements and potential risks to the products from any deliberate attempt to inflict contamination or damage?

  8. Are procedures and controls (firewalls) in place to avoid systemic collapse or contamination if one of the linked entities should experience business interruptions for whatever reason?

  9. Are ventilation systems designed and constructed so that air does not flow from contaminated areas to clean areas and, where necessary, they can be adequately maintained and cleaned?

  10. Are adequate means of natural or mechanical ventilation provided, in particular to minimize air-borne contamination of food, for example, from aerosols and condensation droplets?


Complete the self assessment, on your own or with a team in a workshop setting. Use the workbook together with the self assessment requirements spreadsheet:

  • The workbook is the latest in-depth complete edition of the ISO 14644 book in PDF containing 997 requirements, which criteria correspond to the criteria in...

Your ISO 14644 self-assessment dashboard which gives you your dynamically prioritized projects-ready tool and shows your organization exactly what to do next:

  • The Self-Assessment Excel Dashboard; with the ISO 14644 Self-Assessment and Scorecard you will develop a clear picture of which ISO 14644 areas need attention, which requirements you should focus on and who will be responsible for them:

    • Shows your organization instant insight in areas for improvement: Auto generates reports, radar chart for maturity assessment, insights per process and participant and bespoke, ready to use, RACI Matrix
    • Gives you a professional Dashboard to guide and perform a thorough ISO 14644 Self-Assessment
    • Is secure: Ensures offline data protection of your Self-Assessment results
    • Dynamically prioritized projects-ready RACI Matrix shows your organization exactly what to do next:

 

STEP 3: Implement, Track, follow up and revise strategy

The outcomes of STEP 2, the self assessment, are the inputs for STEP 3; Start and manage ISO 14644 projects with the 62 implementation resources:

  • 62 step-by-step ISO 14644 Project Management Form Templates covering over 1500 ISO 14644 project requirements and success criteria:

Examples; 10 of the check box criteria:

  1. Human Resource Management Plan: How can below standard performers be guided/developed to upgrade performance?

  2. Change Request: What should be regulated in a change control operating instruction?

  3. Schedule Management Plan: Is there a formal process for updating the ISO 14644 project baseline?

  4. Project Scope Statement: Relevant - ask yourself can you get there; why are you doing this ISO 14644 project?

  5. Roles and Responsibilities: Is there a training program in place for stakeholders covering expectations, roles and responsibilities and any addition knowledge others need to be good stakeholders?

  6. Cost Management Plan: Cost management Ð how will the cost of changes be estimated and controlled?

  7. Responsibility Assignment Matrix: Can the contractor substantiate work package and planning package budgets?

  8. Probability and Impact Matrix: How would you assess the risk management process in the ISO 14644 project?

  9. Project Schedule: Activity charts and bar charts are graphical representations of a ISO 14644 project schedule ...how do they differ?

  10. Responsibility Assignment Matrix: Does the contractors system identify work accomplishment against the schedule plan?

 
Step-by-step and complete ISO 14644 Project Management Forms and Templates including check box criteria and templates.

1.0 Initiating Process Group:

  • 1.1 ISO 14644 project Charter
  • 1.2 Stakeholder Register
  • 1.3 Stakeholder Analysis Matrix


2.0 Planning Process Group:

  • 2.1 ISO 14644 project Management Plan
  • 2.2 Scope Management Plan
  • 2.3 Requirements Management Plan
  • 2.4 Requirements Documentation
  • 2.5 Requirements Traceability Matrix
  • 2.6 ISO 14644 project Scope Statement
  • 2.7 Assumption and Constraint Log
  • 2.8 Work Breakdown Structure
  • 2.9 WBS Dictionary
  • 2.10 Schedule Management Plan
  • 2.11 Activity List
  • 2.12 Activity Attributes
  • 2.13 Milestone List
  • 2.14 Network Diagram
  • 2.15 Activity Resource Requirements
  • 2.16 Resource Breakdown Structure
  • 2.17 Activity Duration Estimates
  • 2.18 Duration Estimating Worksheet
  • 2.19 ISO 14644 project Schedule
  • 2.20 Cost Management Plan
  • 2.21 Activity Cost Estimates
  • 2.22 Cost Estimating Worksheet
  • 2.23 Cost Baseline
  • 2.24 Quality Management Plan
  • 2.25 Quality Metrics
  • 2.26 Process Improvement Plan
  • 2.27 Responsibility Assignment Matrix
  • 2.28 Roles and Responsibilities
  • 2.29 Human Resource Management Plan
  • 2.30 Communications Management Plan
  • 2.31 Risk Management Plan
  • 2.32 Risk Register
  • 2.33 Probability and Impact Assessment
  • 2.34 Probability and Impact Matrix
  • 2.35 Risk Data Sheet
  • 2.36 Procurement Management Plan
  • 2.37 Source Selection Criteria
  • 2.38 Stakeholder Management Plan
  • 2.39 Change Management Plan


3.0 Executing Process Group:

  • 3.1 Team Member Status Report
  • 3.2 Change Request
  • 3.3 Change Log
  • 3.4 Decision Log
  • 3.5 Quality Audit
  • 3.6 Team Directory
  • 3.7 Team Operating Agreement
  • 3.8 Team Performance Assessment
  • 3.9 Team Member Performance Assessment
  • 3.10 Issue Log


4.0 Monitoring and Controlling Process Group:

  • 4.1 ISO 14644 project Performance Report
  • 4.2 Variance Analysis
  • 4.3 Earned Value Status
  • 4.4 Risk Audit
  • 4.5 Contractor Status Report
  • 4.6 Formal Acceptance


5.0 Closing Process Group:

  • 5.1 Procurement Audit
  • 5.2 Contract Close-Out
  • 5.3 ISO 14644 project or Phase Close-Out
  • 5.4 Lessons Learned

 

Results

With this Three Step process you will have all the tools you need for any ISO 14644 project with this in-depth ISO 14644 Toolkit.

In using the Toolkit you will be better able to:

  • Diagnose ISO 14644 projects, initiatives, organizations, businesses and processes using accepted diagnostic standards and practices
  • Implement evidence-based best practice strategies aligned with overall goals
  • Integrate recent advances in ISO 14644 and put process design strategies into practice according to best practice guidelines

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

Unless you are talking a one-time, single-use project within a business, 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?'

This Toolkit empowers people to do just that - whether their title is entrepreneur, manager, consultant, (Vice-)President, CxO etc... - they are the people who rule the future. They are the person who asks the right questions to make ISO 14644 investments work better.

This ISO 14644 All-Inclusive Toolkit enables You to be that person.

 

Includes lifetime 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.