Design Controls Toolkit

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Create high quality deliverables using appropriatE Business and technical language, especially developing and reviewing Audit Programs or testing steps, adapting an audit program to suit a clients specific environment, and/or Design Controls evaluations and testing Work Plans.

More Uses of the Design Controls Toolkit:

  • Collaborate with cross disciplinary teams developing design strategies, System Architectures, functional diagrams and lead the generation of concepts.

  • Confirm your team ensures security design, controls, and procedures are aligned with Information security Standards and are appropriate to Mitigate Risk of exposure.

  • Pilot: actively lead the interactions with the Contract Manufacturer and suppliers as IT related to quality and provide support in the resolution of quality problems.

  • Ensure you direct; lead system level Root Cause investigations, coordinate design improvements with development partners, Strategic Planning and execution of Design Changes and improvements.

  • Orchestrate: complete planning and execution of Design Controls, Risk Management, test method development and validation, design verification/validation for new and existing products.

  • Formulate the medium term regulatory policy into a regulatory Strategic Plan, while also being involved in developing, modifying and executing organization regulatory strategies and policies that affect immediate operations.

  • Support post Market Surveillance processes through the analysis of field performance, identification of trends and risks, and actions to eliminate or mitigate adverse post market issues.

  • Support New Product Introduction projects through development and execution of process Validation And Verification Test Plans, protocols, and reports.

  • Provide guidance and decisions on Product Development activities to ensure continued compliance with internal procedures, and applicable regulatory and international standards.

  • Arrange that your team supports design assurance quality engineers with product improvement through implementation of Quality Management policies, procedures, specifications, Test Methods and Measurement Systems.

  • Secure that your business acts an ambassador for and demands adherence to Program Management, Design Controls, Technical Documentation, and Quality Assurance discipline.

  • Lead the Risk Management Process ensuring that the essential performance aspects are correctly mitigated in the Product Quality plans.

  • Contribute to Technical Requirements, architecture, specifications, and design documentation compliant with your established Quality System and Design Controls.

  • Warrant that your planning contributes to defining the direction for new products, processes, standards, or operational plans based on Business Strategy with a significant impact on work group results.

  • Execute packaging development activities in alignment with the elements of Design Controls, and ensure that all packaging materials/systems comply with departmental and applicable Regulatory Requirements.

  • Ensure your group adheres to stated Policies and Procedures relating to Health And Safety, and Quality Management in support of your organizations SOPs and Best Practices.

  • Drive improvement in regulatory aspects of the Quality System, developing processes and documenting procedures to ensure an effective Quality System.

  • Control: confident when interacting with various levels of management, stays focused and on point, and can raise problems or challenges in a productive manner.

  • Perform Requirements Engineering management, ensuring requirements are structured, organized, maintained, and communicated across multi disciplined and multi site teams.

  • Manage work with Systems Engineering and other cross disciplinary engineering functions to support development of Test Cases and protocols for design verification.

  • Formulate: actively engage and support the device development engineering core team to ensure the combination product and engineering execution against the established requirements.

  • Ensure you challenge; build relationships with technical and compliance teams to deliver Privacy by Design Controls that are incorporated into Security Architecture, infrastructure, and code.

  • Confirm your venture complies; directs quality Engineering Support activities for Product Development programs and ensures appropriate quality representation across all teams.

  • Handle projects of various product and subsystem types (System, Software, Hardware, Mechanical, Vision, new products, Product Improvements, etc).

  • Ensure you advance; lead with extensive knowledge in the areas of Design Controls, Design Validation And Verification, Risk Management, Process Validation, manufacturing practices/principles, and Statistical Techniques.

  • Facilitate Project Team meetings, cross functional communication and Decision Making, ensuring alignment with internal and External Stakeholders.

  • Confirm your project represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels.

  • Provide Technical Support based on overall Project Plans with the development of products in compliance with Design Controls and processes in compliance with Good Manufacturing Practices (GMP).

  • Generate test protocols, manage test execution, investigate test issues, analyze data, and create reports for design Verification And Validation testing.


Save time, empower your teams and effectively upgrade your processes with access to this practical Design Controls Toolkit and guide. Address common challenges with best-practice templates, step-by-step Work Plans and maturity diagnostics for any Design Controls 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 Design Controls specific requirements:

STEP 1: Get your bearings

Start with...

  • The latest quick edition of the Design Controls 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 999 new and updated case-based questions, organized into seven core areas of Process Design, this Self-Assessment will help you identify areas in which Design Controls improvements can be made.

Examples; 10 of the 999 standard requirements:

  1. How do you focus on what is right -not who is right?

  2. Who is responsible for errors?

  3. How can a Design Controls test verify your ideas or assumptions?

  4. Has implementation been effective in reaching specified objectives so far?

  5. What are the Strategic Priorities for this year?

  6. How will success or failure be measured?

  7. How do senior leaders deploy your organizations vision and values through your leadership system, to the workforce, to key suppliers and partners, and to customers and other stakeholders, as appropriate?

  8. How do you identify the kinds of information that you will need?

  9. How do you keep the momentum going?

  10. Whose voice (department, ethnic group, women, older workers, etc) might you have missed hearing from in your company, and how might you amplify this voice to create positive momentum for your business?

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 Design Controls book in PDF containing 994 requirements, which criteria correspond to the criteria in...

Your Design Controls 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 Design Controls Self-Assessment and Scorecard you will develop a clear picture of which Design Controls 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 Design Controls 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 Design Controls projects with the 62 implementation resources:

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

Examples; 10 of the check box criteria:

  1. Cost Management Plan: Eac -estimate at completion, what is the total job expected to cost?

  2. Activity Cost Estimates: In which phase of the Acquisition Process cycle does source qualifications reside?

  3. Project Scope Statement: Will all Design Controls project issues be unconditionally tracked through the Issue Resolution process?

  4. Closing Process Group: Did the Design Controls Project Team have enough people to execute the Design Controls Project Plan?

  5. Source Selection Criteria: What are the guidelines regarding award without considerations?

  6. Scope Management Plan: Are Corrective Actions taken when actual results are substantially different from detailed Design Controls Project Plan (variances)?

  7. Initiating Process Group: During which stage of Risk planning are risks prioritized based on probability and impact?

  8. Cost Management Plan: Is your organization certified as a supplier, wholesaler, regular dealer, or manufacturer of corresponding products/supplies?

  9. Procurement Audit: Was a formal review of tenders received undertaken?

  10. Activity Cost Estimates: What procedures are put in place regarding bidding and cost comparisons, if any?

Step-by-step and complete Design Controls 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 Design Controls 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 Design Controls project or Phase Close-Out
  • 5.4 Lessons Learned



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

In using the Toolkit you will be better able to:

  • Diagnose Design Controls 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 Design Controls 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 Design Controls investments work better.

This Design Controls 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.