Archive for the ‘Specific compliance issues Paradigm 3 can manage’ Category

Preventive action (PA, CAPA)

Tuesday, February 24th, 2009
  • Record preventive actions initiatives and track progress towards a solution.
  • Assign staff to roles for registering, investigation, implementation and verification stages.
  • Automatically issue Action Items to staff responsible as each stage of the cycle become due.
  • Link (Para-Link®) corrective actions to relevant documentation, reports and e-forms.
  • Use the progress tracker tool for instant status reporting.
  • Maintain activity history.
  • Track versions.
  • Build standard reports as monitoring tools and management reports.
  • Plus many more standard features with Paradigm 3.

To manage preventive action, you can purchase the Improvement Module.

Environmental aspects

Tuesday, February 24th, 2009
  • Document environmental plans or reviews using Microsoft Word and have the responsible person electronically approve. Once approved automatically send a notification with each version change (Action Item) to those who need to know.
  • Use completed Action Items as evidence that the item have been read.
  • Assign staff to roles as planners, writers, reviewers and approvers etc.
  • Insert roles into the document to automatically update when job title changes.
  • Use document control insert fields within the document to automatically update as changes occur:- item name changes, approver’s name, version, version date and many more.
  • Set review schedule and assign staff to a role for automatic review notifications.
  • Electronically manage aspect documentation amendments with the ability to collaborate with others.
  • Maintain versioning with history in accordance with international document control standards
  • Crosslink (Para-Link®) aspects to associated documentation like reports, test results, plans or folders etc. Links are maintained even when items are renamed or moved.
  • Automatically maintain all relevant history for audit traceability.
  • Plus many more standard features included in Paradigm 3.

To manage environmental management documentation, you can purchase the Document Module.

Internal and external audits

Tuesday, February 24th, 2009

Internal

  • Create templates, audit checklists and audit reports using Microsoft Word or Excel.
  • Develop audit programs by setting audit schedules linked to the checklist/reports formats. When schedules dates are reached, automatically notify auditors with an Action Item to conduct an audit.
  • Extract audit findings requiring action into Action Items and assign to responsible person.
  • Or raise major non conformances where multiple staff input is required in the Improvement module. Action Items are then raised to responsible staff as each stage of the corrective action process. Example, root cause analysis, planned corrective action, action taken and verification.
  • Use completed Action Items with actions as evidence of action taken.
  • Assign staff to roles as audit/checklist template writers, approvers and auditors etc.
  • Link (Para-Link®) audits to associated documentation such as procedures, plans or folders etc. Links are maintained even when items are renamed or moved.
  • Automatically maintain all relevant history for audit traceability.
  • Plus many more standard features included in Paradigm 3.

External

  • Import the external audit report into Paradigm 3 and lock as evidence.
  • Extract audit findings that require action into Action Items and assign staff to responsible person and completion date.
  • Use completed Action Items with actions as evidence of action taken.
  • Or raise major non conformances where multiple staff input is required in the Improvement module. Action Items are then raised to responsible staff as each stage of the corrective action process is completed. Example, root cause analysis, planned corrective action, action taken and verification.

To manage audit documentation and Action Items as the corrective action tool, you can purchase the Document Module only.

If more control is required for corrective action, you can also purchase the Improvement Module.

Electronic forms

Tuesday, February 24th, 2009
  • Design template forms using Microsoft Word or Excel and have the responsible person electronically approve. Once approved automatically send a notification with each version change (Action Item) to those who need to know.
  • You can use completed Action Items as evidence that the item has been read.

Non conformity

Tuesday, February 24th, 2009
  • Register each non conformity and track progress towards resolution
  • Assign staff to roles for registering, assessment and outcome stages
  • Automatically issue Action Items to staff responsible as each stage of the cycle is due
  • Attach photo’s, emails, reports, pdf’s to the non conformity
  • Use the Progress Tracker tool for instant status reporting
  • Maintain activity history
  • Track versions
  • Plus many more standard features with Paradigm 3.

To manage non conformity, you can purchase the Improvement Module.

Continual improvements

Tuesday, February 24th, 2009
  • Monitor staff work efficiency by analysing the Action Item activity.
  • Measure management compliance performance.
  • Since all information is retained, conduct comparisons of management system processing cycles. Examples: non conformity deducing rates, corrective action effectiveness, document processing to approval workloads.
  • Plus many more standard features with Paradigm 3.

Continual improvement is incorporated into all modules purchased.

 

Corrective action (CA, CAPA, NCR, CAR)

Tuesday, February 24th, 2009
  • Record issues that require corrective actions from audits, product failures, testing, validations, process control and track progress towards resolution.
  • Assign staff to roles for registering, investigation, implementation and verification stages.
  • Automatically issue Action Items to staff responsible as each stage of the cycle become due
  • Link (Para-Link®) corrective actions to relevant documentation, reports and eforms.
  • Use the Progress Tracker tool for instant status reporting.
  • Maintain activity history.
  • Track versions.
  • Plus many more standard features with Paradigm 3.

To manage corrective action, you can purchase the Improvement Module.

Management reviews

Monday, February 23rd, 2009
  • Set management review schedules to hold meeting or workshops and automatically notify recipients.
  • Document reviews using Microsoft Word and have the responsible person approve the reviews. Once approved send notification linked to the document to attendees.
  • Assign staff to roles for coordinators, attendees, chairperson.
  • Extract text from the review and convert them to notifications (Action Items) which must be completed by recipients. Assign staff to with responsibility and completion date.
  • Action Item recipients have a direct link to the review documentation and record action taken within the Action Item as evidence.
  • Track progress on open and completed Action Items.
  • Link (Para-Link®) review to supporting evidence.
  • Maintain activity history.
  • Track versions.
  • Plus many more standard features included in Paradigm 3.

To manage management reviews, you can purchase the Document Module.

 

 

 

 

Policies and manuals

Wednesday, February 18th, 2009
  • Document policies using Microsoft Word and have the responsible person electronically approve. Once approved, automatically send notification (Action Items) to those who need to know with each version change.
  • Use completed Action Items as evidence that the items have been read.
  • Assign staff to roles for policy writers, manual writers, reviewers, approvers.
  • Insert roles into the document to automatically update when job title changes.
  • Use document control insert fields within the document to automatically update as changes occur:- item name changes, approver’s name, version, version date and many more.
  • Set review schedule and assign staff to a role for automatic review notifications.
  • Electronically manage policy amendments with the ability to collaborate with others.
  • Maintain versioning with history in accordance with international document control standards.
  • Link (Para-Link®) policies to associated documentation like procedures, plans or folders, etc.  Links are maintained even when items are renamed or moved.
  • Automatically maintain all relevant history for audit traceability.
  • Plus many more standard features included in Paradigm 3.

To manage policies, you can purchase the Document Module.

Objectives and targets

Wednesday, February 18th, 2009
  • Categorise objective by discipline, personnel or position title.
  • Register each objective and monitor progress towards the targets and goals.
  • Set schedules to notify key personnel to review and or update.
  • Link (Para-Link®) objectives to corresponding plans, policies or relevant documentation.
  • Progressively sign off each stage.  Example: Objective definition, strategy to achieve and measurement techniques.
  • Use the Progress Tracker tool for instant status report.
  • Maintain activity history.
  • Assign staff to roles of who is accountable for each sign off section, writers and approvers, etc.
  • Track versions.
  • Plus many more standard features with Paradigm 3.

To manage objectives and targets, you can purchase the Improvement Module.

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