QIA recommends the following modules for medium size manufacturing entities to manage their Quality Management System.  All modules share a common theme of initiating tasks, follow Best Practice workflow and help manage it through alerts, escalations. As tasks are done, records are generated and stored automatically, allowing for powerful analysis and reporting. Advanced searches are also available. Apart from the best practice fields already programmed in, custom forms with workflows can be created by you with ease. All modules are integrated with the others. Use of QISS assures water-tight compliance with standards, and auditors will be impressed.

 The bundle shown below can cost as low as $290 per month

 Document Management

– Key Features/Benefits

  • Configurable workflow for review, approval and release of documents
  • Ability to revise documents
  • Ability to add custom fields
  • Auto generated document control numbers to reflect document’s type, department, and section of the standard with a watermark that can display/print document control number and the revision number of a document
  • An automatic reminder will be sent to the document owner when the document is scheduled for review
  • The document owner has the option to review and make changes, assign the work to others, or to leave the document in its current revision and schedule another review later as required

 Records Management

– Key Features/Benefits

  • Can add records with/without link to a document in document management module
  • Categorize records by record type
  • Ability to edit or obsolete already uploaded record
  • Advanced search feature to filter out records by specifying filtering criteria

 Non-conformance

– Key Features/Benefits

  • Ability to initiate internal, supplier, or customer NCRs
  • Ability to add custom fields
  • Ability for customer representative to initiate NCRs
  • Ability to send to MRB members
  • Ability to setup Failure modes, Categories and Disposition types
  • Ability to make Disposition Actions
  • Dashboard to view pending assignments
  • Analytics – Configurable charts and reports
  • Ability to undo last action
  • Charts & Reports

 Corrective Actions

– Key Features Benefits

  • Ability to initiate CAR from existing NCR, or from an identified risk
  • Ability to initiate internal, supplier, or customer CARs
  • Ability to add custom fields
  • Ability to save current work so that it can be completed later
  • Ability to assign supplier representative to complete activities for a supplier CAR
  • Ability for customer representative to initiate CARs
  • Ability to assign a responsible person for each CAR
  • Ability to control approvers for each CAR step
  • Advanced search feature to filter out records by specifying multiple match criteria
  • Ability to undo last action
  • Ability to edit CAR
  • Dashboard to view pending assignments
  • Ability to initiate CAR from “Audit” and “HSE” reports
  • Ability to manage “Risk Management” using FMEA or ERM method
  • Ability to configure RPN matrix or Risk score
  • Ability to record revised RPN with contingency plan
  • Charts & Reports

 Training

– Key Features/Benefits

  • Ability to setup competence categories
  • Ability to complete training as self-acceptance or class-room training
  • Automatic training notification about the training
  • Ability to trigger repetitive training requests
  • Evaluation for completed trainings
  • Ability to attach certificate during evaluation
  • Automatic training needs assessment reminders
  • Automatic training need assignments when job title and/or department is/are changed
  • Ability to upload already completed training records
  • Ability to attach “Sign In” sheet with schedule training
  • Prompt for training needed on document latest revision as soon as document released
  • Ability to view “Upcoming Trainings”
  • Charts & Reports

 Risk Management

– Key Features/Benefits

  • Configure RPN/Risk Score
  • Select FMEA/ERM method
  • Initiate a Risk Assessment
  • Search Risk Database (Risk Register) to minimize same type of Risk to record in the risk register. This can automatically alert initiator of similar risks in the past.
  • Initiate internal, supplier, or customer Risks
  • Add custom fields
  • Assign a responsible person for each Risk assessment
  • Add to a consequence with RPN number
  • Charts & Reports
  • Advanced search feature to filter out records by specifying multiple match criteria
  • Initiate a local prevention for a risk that has already been assessed
  • Add custom fields
  • Assign a responsible person for each Risk Prevention (RP)
  • Complete RP steps (Developing Solution, Implementing Solution and verifying effectiveness)
  • Control approvers for each RP step.
  • Record new revised RPN/Risk Score.
  • Formulate a contingency plan
  • Charts & Reports
  • Advance email notification about due dates
  • Advanced search feature to filter out records by specifying multiple match criteria
  • Undo last action
  • Edit last completed action
  • Dashboard to view pending assignments

 Auditing

– Key Features/Benefits

  • Ability to schedule an internal audit for a single department or for an entire organization
  • Ability to setup auditors
  • Ability to setup checklist
  • Ability to add an audit report and close it out
  • Ability to initiate an NCR or a CAR

 Management Review

– Key Features/Benefits

  • Allows you to setup management committee
  • Send out notification for scheduled management review
  • Allows you to schedule the meeting
  • Allows you to attach Agenda for each meeting
  • Automatically builds the organization chart

 Calibration

– Key Features/Benefits

  • Ability to import equipment records from external excel source
  • Ability to setup advanced tolerance feature so that deviations from acceptable tolerance limits can be automatically flagged on
  • Ability to add custom fields
  • Ability to filter out calibration records according to specified search criteria
  • Inventory of measurement equipment
  • Calibration schedules with auto reminders based on equipment frequencies
  • Ability to record results of calibrated equipment

 Maintenance

– Key Features/Benefits

  • Ability to perform scheduled maintenance and breakdown maintenance
  • Ability to add custom fields
  • Ability to filter out maintenance records according to specified search criteria
  • Ability to see upcoming maintenance schedule for all equipment
  • Ability to provide Total Downtime and Cost during the maintenance period
  • Maintenance schedules with auto reminders based on equipment frequencies
  • Ability to record results of equipment
  • Ability to perform breakdown maintenance

 Engineering Change Management

– Key Features/Benefits

  • Engineering Change Request (ECR) for Drawing, BOM etc.
  • Approval process for ECR before proceeding to ECN
  • Workflow with delegation until ECN implementation
  • Ability to associate impacted items
  • Determination of inventory quantity & location of impacted items
  • Determine Disposition of impacted items & associated cost
  • Review process for determined disposition & cost estimation
  • Approval for ECN & Notification for Implementation
  • Confirmation for Implementation from involved parties
  • Review ECN and ensure all necessary actions have been completed