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Quality Management System - Process Variables


QMS Variable Controls Applicable To Variable
Materials - Raw materials, wip, & finished goods
- Inventory management
- Non production materials & supplies
- Inspections & Tests
- Standards & Specifications
- Supplier Management
- Identification & Traceability
- Turnover & Preservation
Machine - Production equipment & technology
- Engineering & support
- Inspection, measuring & test equipment
- Tools, dies & fixtures
- Maintenance & supplies
- Equipment layout
Manpower - Skills, knowledge & experience
- Training
- Responsibility & Authority
- Motivation & Morale
- Communication & Interpersonal skills
- Adequate staffing
- Health & Safety
Mileu/Environment - Building & facilities
- Environment controls
- HVAC and other utilities
- Housekeeping, health & safety
- Lighting, air quality & noise
- Contingency/emergency measures
Methods - Systems & Procedures
- Inspection & Tests
- Quality Plans & Checklists
- Work Instructions
- Bill of manufacture/assembly
- Technology/automation
- Process flowcharts
- FMEA’s & process controls
- Drawings & blueprints
Measurement - Objectives/tracking/review/improvement
- Standards/codes/regulations
- Specifications/tolerances/criteria/tolerances
- Operational data/statistics/SPC
- Efficiency & effectiveness
- Customer Satisfaction
- Bench-marking
Management - Leadership & Planning
- Policies & Objectives
- Commitment & involvement
- Organization & resources
- Follow-up & review
- Communication
Markets - Market share & penetration
- Customer base
- Channels of distribution
- Market analysis & trends
- Pricing & product positioning
- Product/service range
- Competition
- Opportunities/challenges
How To Use These QMS Process Variables:

- Determine which of these process variable in the left hand column apply for each process identified in your QMS.

- Determine which of the controls in the right hand column apply to that process variable (Reference the applicable QMS standard - ISO 9001; TS 16949: etc.)

- Implement the controls you have identified and verify their effectiveness

- This page is a good summary of any QMS standard!!

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QMS Process Variables


QMS Process Metrics