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:

  • Make sure that your group supports design assurance quality engineers with product improvement through implementation of Quality Management policies, procedures, specifications, Test Methods and measurement systems.

  • Drive partnership between hardware engineering, Electrical Engineering, Software Engineering, marketing, and testing using a Systems Engineering approach throughout the Product Development lifecycle.

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

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

  • Participate as key Quality Leader in organizational activities as Product Design review, Phase Gate review, Quality Review Board, CAPA Review Board, and other related activities.

  • Warrant that your project
  • Contribute to technical requirements, architecture, specifications, and design documentation compliant with your established Quality System and Design Controls.

  • Establish: conduct exploratory research, evaluate Ideation concepts, translate User Needs into requirements and specifications, iteratively evaluate device user interface, perform Risk Assessments, and Usability Testing.

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

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

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

  • Collaborate closely with cross functional team members mechanical, electronic, software, clinical, regulatory, and Quality engineering disciplines to design iterations to quickly and effectively develop effective User Interfaces.

  • Support new product introduction projects through development and execution of Process Validation and verification Test Plans, protocols, and reports.

  • Arrange that your group 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.

  • Provide technical guidance and support based on overall project plans with the development of products in compliance with Design Controls, processes in compliance with Good Manufacturing Practices (cGMP).

  • 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.

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

  • Control: actively lead the interactions with the contract manufacturer and suppliers as IT related to quality and provide support in the resolution of quality problems.

  • 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.

  • Ensure your enterprise adheres to stated Policies and Procedures relating to Health And Safety, and Quality Management in support of your organizations SOPs and best practices.

  • Coordinate: creative and innovative thinking to resolve issues and overcome obstacles, using sound judgment and structured methods to effectively analyze options, risks and implications.

  • Formulate: work is expected to result in significant contributions to the development of new or refined equipment, materials, processes, products, and/or methods.

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

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

  • Determine feasibility of designing equipment or modifying existing equipment considering costs, time limitations, organization planning, and other technical and economic factors.

  • 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.

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

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

  • Ensure you consult; lead system level root cause investigations, coordinate design improvements with development partners, Strategic Planning and execution of design changes and improvements.

  • 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).


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. What is the smallest subset of the problem you can usefully solve?

  2. How do you gather requirements?

  3. What system do you use for gathering Design Controls information?

  4. How has the Design Controls data been gathered?

  5. What are the concrete Design Controls results?

  6. What is the scope of Design Controls?

  7. What vendors make products that address the Design Controls needs?

  8. Can you do Design Controls without complex (expensive) analysis?

  9. What are allowable costs?

  10. How do you link measurement and risk?

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:

  • 2.1 Design Controls Project Management Plan
  • 2.2 Scope Management Plan
  • 2.3 Requirements Management Plan
  • 2.4 Requirements Documentation
  • 2.5 Requirements Traceability Matrix
  • 2.6 Design Controls 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 Design Controls 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 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.