ISO 9001 Consulting-What are process variables?

By | June 17, 2017

ISO 9001 Consulting

QMS Process Variables

QMS Variable  Variable Attributes
Materials – Raw materials, wip, & finished goods
– Inventory management
– Non production materials & supplies
– Inspections & Tests
– Standards & Specifications
– Supplier Management
– Identification & Traceability
– Handling & 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
– Adequate staffing
– Health & Safety
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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

ISO 9001 Consulting-What are process variables?

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 variable attributes in the right hand column apply to that process variable (Reference the applicable QMS standard – ISO 9001; TS
    16949: etc.)
  • Implement appropriate controls for each of the variable attributes you have selected and verify their
    effectiveness
    .

For more information on process variables and their controls, check out the eCourse “Understanding ISO 9001:2015

ISO 9001 Consulting-What are process variables?

ISO 9001 Consulting eCourse