Quality Systems Toolkit

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Monitor key Quality System metrics, process indicators, and overall health of the cGMP Quality Management System (QMS) to proactively identify and address Quality Systems or product issues and ensure its continuing stability, effectiveness, and improvement.

More Uses of the Quality Systems Toolkit:

  • Make sure that your business applies system engineering principles to develop cost effective, reliable, high Quality Systems that satisfy customer needs and drive business strategies.

  • Identify and record any problems relating to the product, process, or Quality Systems; Control further processing and delivery of nonconforming product until the deficiency is corrected.

  • Lead the development and implementation of innovative and beneficial programs/projects aimed at improving Customer Satisfaction, Quality Systems, and Operational Efficiency.

  • Take responsibility for all aspects of your Supply Chain, working with suppliers to ensure complete compliance with your Quality Systems, and ethical policies while optimizing your costs and overall efficiencies.

  • Be accountable for providing internal and external technical training in statistical Process Control, quality specifications, Quality Systems, and customer expectations.

  • Lead Internal Audits for Quality Systems, processes, and products to ensure compliance with regulations and internal specifications.

  • Be accountable for coaching and mentoring of employees through technical instruction around your organizations Quality Systems through monthly training sessions.

  • Warrant that your organization keeps informed of all existing and new Regulatory Requirements and helps maintain compliance in your organizations Quality Systems.

  • Organize: strategic agility gains perspective and balances the pressure between daily tasks and strategic actions that impact the long term viability of your organization.

  • Provide direction, leadership, and training for the identification, implementation, and use of effective and efficient Quality Systems and procedures.

  • Be certain that your operation assess engine components and tools, supplier Quality Systems, supplier selection, and Strategic Sourcing process development with the objective of overall Quality Improvement and resolution of Supplier Quality issues.

  • Devise: plan, lead, manage, Process Control and activities related to Quality Systems management, to assure customer standards and regulations compliance, and Continuous Improvement.

  • Be certain that your enterprise contributes to the development of high Quality Systems and products by ensuring adoption of standards, best practices, Processes And Procedures at every phase of the Software Development lifecycle; requirements to release.

  • Be accountable for working closely with the Quality Management (owner of Quality Systems and associated audits) to identify critical Audit Process and/or compliance gaps and take appropriate actions.

  • Develop training in quality, Problem Solving and Continuous Improvement activities to raise the level of Quality Systems competence in Manufacturing Operations.

  • Develop, implement, communicate and maintain a quality plan to bring your organizations Quality Systems and Policies into compliance with Quality System requirements.

  • Provide Quality Systems technical expertise and/or support to facilities, suppliers, and other functional teams in large complex facilities or where highly regulated products are produced.

  • Methodize: partner with stakeholders and business partners to assess risk and establish proactive Risk Mitigation strategies and enable innovation in emerging areas.

  • Establish that your enterprise complies; conducts Root Cause Analysis, develops action plans and coordinates with team members, so that issues are communicated and resolved quickly and effectively.

  • Ensure quality through adherence to the Quality Systems Manual, applicable Standard Work Instructions and other standards invoked internally or contractually.

  • Perform periodic audits of Supplier Quality Systems for the purpose of assuring continued Supplier conformance to the Quality System requirements.

  • Confirm your group provides support for New Product Development and guides team through the development process to ensure compliance to Quality Systems.

  • Confirm your operation supports the design, implementation and maintenance of the Quality Systems, procedures, and policies to ensure compliance with the current regulations and all applicable Regulatory Requirements.

  • Manage work with Enterprise Architecture/information technology and software owners to establish validation needs and drive validation activities.

  • Take the lead on incident/accident investigations while documenting all encompassing causative factors and identifying preventive and corrective measures.

  • Ensure your organization complies; implements and maintains Quality Systems to capture, monitor, and manage product and process quality to support organization tactical and strategic business goals and objectives.

  • Devise: actively lead corporate/cross facility teams to develop and implement new and improved systems as best practices and Quality Systems as need.

  • Evaluate and verify supplier Process Controls and supplier Quality Systems, analyze product failures, facilitate writing and/or approve results of Corrective Actions of suppliers.

  • Ensure your venture determines and implements best Strategic Direction for Quality Systems function with regard to organization, competencies, human and fiscal Resource Planning, quality planning and Quality Systems best practices.

  • Secure that your organization supports and coordinates software and potential hardware modifications using Software Development Life Cycle (SDLC) best practices in conjunction with established Change Control policies.


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

STEP 1: Get your bearings

Start with...

  • The latest quick edition of the Quality Systems 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 Quality Systems improvements can be made.

Examples; 10 of the 999 standard requirements:

  1. What are the business goals Quality Systems is aiming to achieve?

  2. In the case of a Quality Systems project, the criteria for the audit derive from implementation objectives, an audit of a Quality Systems project involves assessing whether the recommendations outlined for implementation have been met, can you track that any Quality Systems project is implemented as planned, and is it working?

  3. How do you catch Quality Systems definition inconsistencies?

  4. What counts that you are not counting?

  5. How do you use Quality Systems data and information to support organizational Decision Making and innovation?

  6. What gets examined?

  7. What causes investor action?

  8. The approach of traditional Quality Systems works for detail complexity but is focused on a systematic approach rather than an understanding of the nature of systems themselves, what approach will permit your organization to deal with the kind of unpredictable emergent behaviors that dynamic complexity can introduce?

  9. How do you measure variability?

  10. Why do you expend time and effort to implement measurement, for whom?

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 Quality Systems book in PDF containing 994 requirements, which criteria correspond to the criteria in...

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

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 Quality Systems project issues be unconditionally tracked through the Issue Resolution process?

  4. Closing Process Group: Did the Quality Systems project team have enough people to execute the Quality Systems 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 Quality Systems 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 Quality Systems 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 Quality Systems 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 Quality Systems project or Phase Close-Out
  • 5.4 Lessons Learned



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

In using the Toolkit you will be better able to:

  • Diagnose Quality Systems 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 Quality Systems 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 Quality Systems investments work better.

This Quality Systems 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.