Equipment Qualification Toolkit

$495.00
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Develop and oversee Equipment Qualification and Process Validation plans and lead Continuous Improvement projects based on process/product trends, customer complaints, Industry Standards and government regulations.

More Uses of the Equipment Qualification Toolkit:

  • Audit: Equipment Qualification and computer systems validation.

  • Manage: Equipment Qualification, maintenance and calibration research new equipment, methods, and procedures to support ongoing product improvements and new product initiatives.

  • Become the expert in technical leadership or process/ Equipment Qualification and development methodologies.

  • Guide: preparation and review of Equipment Qualification reports.

  • Ensure you helm; lead process Equipment Qualification.

  • Lead cross functional teams to establish system requirements and to apply Risk Management techniques to Equipment Qualification/validation.

  • Control: monitor and troubleshoot pertinent equipment; ensure Equipment Qualification, preventive maintenance, and calibration are performed per requirement and by due date.

  • Be accountable for packaging Equipment Qualification.

  • Control: sterile process Equipment Qualification.

 

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


STEP 1: Get your bearings

Start with...

  • The latest quick edition of the Equipment Qualification 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 Equipment Qualification improvements can be made.

Examples; 10 of the 999 standard requirements:

  1. How do you foster innovation?

  2. How can you become the company that would put you out of business?

  3. What is a worst-case scenario for losses?

  4. What intelligence do you gather?

  5. In what way can you redefine the criteria of choice clients have in your category in your favor?

  6. What are the affordable Equipment Qualification risks?

  7. Are supply costs steady or fluctuating?

  8. How will you insure seamless interoperability of Equipment Qualification moving forward?

  9. What are the costs and benefits?

  10. Have all non-recommended alternatives been analyzed in sufficient detail?


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 Equipment Qualification book in PDF containing 994 requirements, which criteria correspond to the criteria in...

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

  • 62 step-by-step Equipment Qualification Project Management Form Templates covering over 1500 Equipment Qualification 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 Equipment Qualification project issues be unconditionally tracked through the Issue Resolution process?

  4. Closing Process Group: Did the Equipment Qualification project team have enough people to execute the Equipment Qualification 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 Equipment Qualification 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 Equipment Qualification Project Management Forms and Templates including check box criteria and templates.

1.0 Initiating Process Group:

  • 1.1 Equipment Qualification project Charter
  • 1.2 Stakeholder Register
  • 1.3 Stakeholder Analysis Matrix


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 Equipment Qualification 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 Equipment Qualification 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 Equipment Qualification project with this in-depth Equipment Qualification Toolkit.

In using the Toolkit you will be better able to:

  • Diagnose Equipment Qualification 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 Equipment Qualification 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 Equipment Qualification investments work better.

This Equipment Qualification 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.