ISO 14644 Toolkit

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Confirm your organization develops direct reports and builds a high performance team through utilization of a Performance Management process that sets expectations, ensures ongoing coaching/mentoring and assesses employee performance.

More Uses of the ISO 14644 Toolkit:

  • Establish that your organization fosters Team Environment to improve efficiency of the maintenance program and develop depth in technical excellence.

  • Guide: direct and manage the daily activities and workflow of packaging engineers.

  • Be accountable for generating and executing validation protocols to demonstrate compliance to a standard suitable for review by internal and External Auditors.

  • Provide drive, leadership, and communication skills to support your mission of living a Continuous Improvement culture.

  • Confirm your organization assures completion of all phases a project in a timely and efficient manner.

  • Develop, revise and review SOPs, qualification/validation protocols and reports.

  • Arrange that your organization Operations Management, manufacturing and packaging engineering.

  • Identify: champion proactive Quality Assurance activities throughout operations and with suppliers.

  • Identify: in close cooperation with engineering, performs repair and troubleshooting of process based instrumentation.

  • Manage the calibration schedule in order to optimize resources and minimize impact to manufacturing scheduling.

  • Ensure you introduce; lead Configuration Management in a joint effort with Automation Engineering.

  • Serve as a liaison between employees, other organizational organizations, and outside contractors to troubleshoot and address issues.

  • Establish that your organization employees are empowered to stop production and notify supervisor/management if an unsafe act or Product Quality concern is occurring.

  • Develop packaging Process Controls to achieve consistent and predictable outcomes.

  • Interact with New Product Development and operations Engineering teams creating and implementing plans for evaluation and testing related to microbiology/clean rooms for new/ modified products and processes.

  • Develop meaningful validation metrics/trending to enable continued drive for reliability and efficiency.

  • Direct: positive coaching to teams during periods of business change/growth.

  • Drive a Continuous Improvement culture based on data trends/Customer Feedback.

  • Secure that your organization supports development of site and departmental metrics to gauge ongoing performance of organization and identification of opportunities for continual Process Improvement.

  • Drive: conduct investigations regarding out of specifications (oos) results and address and manage deviations related to micro procedures.

  • Ensure you accrue; Computerized Maintenance Management System (cmms) principals.

  • Evaluate product and/or process changes for impact on quality.

  • Lead the collection and analysis of validation data.

  • Control: effectively execute projects that improve quality, safety, product cost, risk reduction and plant capabilities.

  • Confirm your organization leads staff to ensure completion of all routine and non routine work and projects in compliance with applicable Standard Operating Procedures.


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 993 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 993 standard requirements:

  1. Have specific points in primary food production activities where a high probability of contamination exists been identified and have specific measures been implemented to minimise the probability?

  2. Have you faced any liability issues with respect to environmental contamination, e.g., at a redevelopment site where some contamination remains after completion of the project?

  3. Are any part-used packaging materials, suitable for use, effectively protected from contamination and clearly identified before being returned to an appropriate storage area?

  4. Is there a written testing program designated to assess the stability characteristics of each product to determine the appropriate storage conditions and expiration dates?

  5. Where staples or other items are present as packaging materials or closures, are appropriate precautions taken to minimise the risk of product contamination?

  6. Are the accuracy, sensitivity, specificity and reproducibility of Test Methods established, documented, validated and subject to regular review and updating?

  7. Is there a program in place to ensure the timely identification and segregation of all products involved in the event of deliberate product contamination?

  8. Is it likely that contamination with the identified hazard could occur in excess of the acceptable level or could increase to an unacceptable level?

  9. Will the need to perform work off-hours present increased risks or additional hazards that would necessitate implementation of additional controls?

  10. Do you assure your customers that all incoming raw materials have been secured during transit and have been inspected for signs of contamination?

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 993 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. Risk Audit: Can analytical tests provide evidence that is as strong as evidence from traditional substantive tests?

  2. Responsibility Assignment Matrix: Is every signing-off responsibility and every communicating responsibility critically necessary?

  3. Network Diagram: If a current contract exists, can you provide the vendor name, contract start, and contract expiration date?

  4. Human Resource Management Plan: Are enough systems & user personnel assigned to the ISO 14644 project?

  5. Human Resource Management Plan: Is a payment system in place with proper reviews and approvals?

  6. Activity Cost Estimates: What is the last item a ISO 14644 Project Manager must do to finalize ISO 14644 project close-out?

  7. Activity Duration Estimates: Is a standard form used to obtain bids and proposals from prospective sellers?

  8. Risk Management Plan: Is the customer willing to commit significant time to the Requirements Gathering process?

  9. Quality Management Plan: How effectively was the Quality Management Plan applied during ISO 14644 project Execution?

  10. Probability and Impact Assessment: Can the risk be avoided by choosing a different alternative?

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

1.0 Initiating Process Group:

2.0 Planning Process Group:

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



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.