Understanding The ISO/TS 16949:2002 Standard 

6.3 Infrastructure  

Your organization shall 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)   

  6.3.1 Plant, facility & equipment planning 

Your organization shall use a multi-disciplinary approach to plan: 

Plant layouts that optimize material travel & handling 

Facilitate synchronous material flow 

Optimize value added use of floor space 

Develop methods to evaluate and monitor effectiveness of existing operations 

Note: Focus on lean manufacturing principles & link to QMS effectiveness 

6.3.2   Contingency plans 

Have contingency plans to satisfy customer requirements for - emergencies such as utility interruptions, labor shortages, key equipment failure and field returns.       

6.4 Work Environment 

Determine and manage the work environment needed to achieve conformity to product requirements 

6.4.1   Personal safety 

Minimize potential risks to employees  & achieve product safety through controls in the D&D and mfg processes 

6.4.2 Premise Cleanliness 

Keep premises in adequate state of order, cleanliness and repair consistent with product & mfg process needs  

Key Explanation Points and Tips: 

Þ      Planning 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. 

Þ      The 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.   

Þ      You must have a facilities plan for developing your infrastructure. This plan must address – plant layout; optimization of material travel and value-added use of floor space; synchronous material flow; waste reduction and lean manufacturing; facility and equipment maintenance; equipment capability and consistency; control of the work environment; employee and product safety; facility day to day housekeeping; and contingency planning. . Review specific requirements for facility planning at OEM customer or IATF websites. 

Þ      The productivity and effectiveness of existing operations must be evaluated through consideration of – ergonomic and human factors; operator and line balance; storage and buffer inventory levels; use of automation; value added content and use of a work plan. 

Þ      You 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. Also see notes under clause 7.5.1.4. 

Þ      You must have contingency plans that includes – availability of alternate remote production sites for multi-site situations; appointment of a responsible person to operate emergency procedures; key equipment/machinery list; maintenance operation records; and outputs of a risk analysis result (similar to a product or process FMEA, but on a more global – business and infrastructure scope). . Review specific requirements for contingency planning at OEM customer or IATF websites. 

Þ      Work 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 ergonomics include - (worker movement; fatigue; manual effort and loads, etc); workplace location; social interaction; heat; light; humidity; airflow; noise; vibration; etc). The applicability and degree to which applicable of these factors will vary from facility to facility. The focus should be employee safety, welfare and product conformity. Review specific requirements at OEM customer or IATF websites. 

Þ      Personnel safety – factors to consider may include – defined responsibility for safety; error-proofing in DFMEA and PFMEA; knowledge and application of regulations; lessons learned from internal/external audits and corrective actions; records of accidents; workplace risk analysis; safety procedures; and use of safety equipment. 

Þ      Facility conditions include - cleanliness of premises. Factors to consider may include – defined responsibilities for order and cleanliness; appropriate disposal conditions; appropriate space and storage conditions; clean intact transport and operating equipment; organized, clean and well lit workplaces and inspection stations; hygiene standards; availability of facilities for lockers; lunchroom; cafeteria; washrooms; etc. . Review specific requirements for cleanliness at OEM customer or IATF websites. 

Þ      Performance 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.