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6.3 Infrastructure
Determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable:
a)Buildings, workspace and associated utilities
b)Process equipment (hardware and software)
c)Supporting services (such as transport or communication)
6.4 Work Environment
Determine and manage the work environment needed to achieve conformity to product requirements
Key Explanation Points and Tips:
ÞPlanning for the types of infrastructure resources needed for your business may include - facility; production equipment; IT equipment and software; laboratory; packaging; dies; molds; tooling; jigs; fixtures; storage; transportation; communication; office; materials; labor; utilities and supplies, etc.
ÞThe key strategic business factors to be considered for infrastructure planning include: future needs; current availability and capacity; cushion for growth; contingency planning; linkage to current and future product programs. This planning may be done through business planning (clause 5.1); quality management planning (5.4) and planning for QMS processes Clause 4.1). The actual deployment of such resources may be determined by each process owner.
ÞYou are required to maintain your infrastructure. Your planned preventive maintenance program should include controls for - schedule and timing; availability and training of personnel; types and scope of maintenance; maintenance and competency/training records; tracking to maintenance objectives; use, storage and control of spare parts; control of any maintenance outsourcing; etc. There are many software programs available to help do this.
ÞWork environment include controls for ergonomics; personnel safety and facility conditions that are conducive to achieving product quality. Some of the factors to consider in determining and managing the work environment include - ergonomics (worker movement; fatigue; manual effort and loads, etc); workplace location; heat; light; humidity; airflow; noise; vibration; hygiene; cleanliness; pollution; adequate facilities (lockers; lunchroom; cafeteria; washrooms; etc); health and safety regulations; cleanliness of premises; etc.
ÞThe extent to which the above environmental factors may apply to any organization will vary based on size, risk and other considerations. The focus should be employee safety, welfare and product conformity.
ÞPerformance indicators to measure the effectiveness of processes (see first paragraph above) that determine and control the effective use of infrastructure may include - equipment maintenance - uptime/downtime; productivity - equipment and workforce; accident and safety incidents; non-value added use of floor space; excessive handling and storage; number of instances specific resources were not available or delayed; etc.
