CAPAs Toolkit

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Collaborate with management in creating and/or reviewing metrics and trend analyses on audits/inspection findings and related CAPAs, for escalation to management and stakeholder.

More Uses of the CAPAs Toolkit:

  • Support Quality Systems activities as ownership of CAPAs, customer complaints, audit finding, etc.

  • Oversee: Technical Support to deviation investigations, Corrective Action prevention plans (CAPAs), and Change Controls is also expected.

  • Follow up on audit observations ensuring timely completion of responses, development of CAPAs and completion of CAPAs.

  • Lead CAPAs to solve manufacturing problems, account for process deviations, and Change Control processes.

  • Be certain that your planning tracks and monitors internal process nonconformities, deviations, complaints, and CAPAs to drive closure.

  • Manage CAPAs in electronic system (document due dates, activities, and promote through workflows and approvals).

  • Formulate: own quality records as Change Controls, evaluation actions, implementation actions, and CAPAs.

  • Provide support to Manufacturing, Quality, Maintenance, and Validation for deviation investigations, Change Controls and CAPAs through participation on Cross Functional Teams.

  • Make sure that your organization provides administrative support through creation of Corrective and preventive action (CAPAs), tracking of finding resolution, and reporting audit metrics.

  • Support technical direction for process related deviations, CAPAs and Change Controls.

  • Steer: review and tracks investigations, deviations, Risk Assessments, Change Controls and CAPAs.

  • Ensure the Quality System/personnel is efficient for the business while maintaining compliance Quality Issues, Change Controls, CAPAs.

  • Secure that your organization supports processes as Document Control, nonconformances, CAPAs, and developing Quality Metrics.

  • Confirm your operation complies; effectiveness checks are performed to ensure ongoing compliance with the implemented CAPAs.

  • Take the lead in ensuring that deviations, CAPAs, and Change Controls issued to your organization are properly tracked, closed on time, or extended if necessary.

  • Verify the timely completion of CAPAs by means of routine contact with the supplier.

  • Devise: own or support identified internal CAPAs and manage to timely Root Cause investigation, implementation and closure.

  • Ensure you administer; lead/lead post Market Risk Management Review with Cross Functional Teams to assure risks are minimized and potential CAPAs are initiated.

  • Confirm your business complies; deviations, CAPAs, documents, audits, approved vendors to ensure compliance with internal and external requirements.

  • Resolve manufacturing issues along with Daily Review of manufacturing investigations, Change Controls, complaints, and CAPAs.

  • Warrant that your business complies; projects stemming from CAPAs, training deficiencies, and general procedural improvements.

  • Confirm your organization complies; deviations, CAPAs, Change Control, documents, audits, approved vendors to ensure compliance with internal and external requirements.

  • Lead mastery of multiple Quality Systems as Deviations, CAPAs, Change Controls, Training and Inspection Readiness.

  • Support Quality Assurance with audits, CAPAs, Change Control, deviations, Root Cause analysis, and complaint handling.

  • Ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs, Change Controls and complaints.

  • Drive: monitor and track and trend deviations, CAPAs, Change Controls to ensure proper documentation, timely closure, and suitable steps identified to prevent recurrence.

  • Confirm your corporation complies; completes audit reports and ensures appropriate CAPAs are identified by the supplier when necessary.

  • Investigate and resolve exceptions, nonconformances, deviations, CAPAs, and Change Controls related to Validation protocols.

  • Pilot: work as a member of a Cross Functional Team to drive Root Cause analysis and CAPAs.

  • Ensure your business acts as a system owner for the Quality Systems department for Change Controls, Deviations, CAPAs and Change Assessments.

 

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


STEP 1: Get your bearings

Start with...

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

Examples; 10 of the 999 standard requirements:

  1. Who pays the cost?

  2. Political -is anyone trying to undermine this project?

  3. What can be used to verify compliance?

  4. What do you need to start doing?

  5. How will CAPAs decisions be made and monitored?

  6. Do you think you know, or do you know you know?

  7. Which costs should be taken into account?

  8. How do you engage the workforce, in addition to satisfying them?

  9. Can you do CAPAs without complex (expensive) analysis?

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


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

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

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

  4. Closing Process Group: Did the CAPAs Project Team have enough people to execute the CAPAs 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 CAPAs 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 CAPAs 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 CAPAs 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 CAPAs 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 CAPAs project with this in-depth CAPAs Toolkit.

In using the Toolkit you will be better able to:

  • Diagnose CAPAs 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 CAPAs 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 CAPAs investments work better.

This CAPAs 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.