Understanding TS 16949

                                   Chapter 8
                    Understanding TS 16949:2002

6   RESOURCE MANAGEMENT

6.1 Provision of Resources
Your organization shall determine and provide the needed resources to:
• Implement and maintain the QMS & continually improve its effectiveness
• Enhance customer satisfaction by meeting their requirements

Key Explanation Points and Tips:
ÞIn clause 5.1e we saw that top management has the responsibility to ensure the availability of resources to develop and maintain your QMS.

Þ Clause 6.1 requires you to determine the nature and availability of such resources. This is typically done through business and quality planning.

Þ Use business planning (clause 5.1); quality management planning (clause 5.4) and planning for QMS processes (clause 4.1), to identify and determine the nature of resource needs of QMS each process and plan for its availability. The actual amount of resources needed may vary day to day and over time. This is one reason why top management must review QMS performance (see clause 5.6.2) regularly.

Þ Having adequate resources is vital (as many organizations run into QMS nonconformities as a result of insufficient or improper use of resources) to ensure product conformity or satisfy customer requirements - e.g. having adequate personnel, materials and equipment to ensure timely production and delivery of product. Review specific requirements for provision of resources at OEM customer or IATF websites.

Þ onsider developing performance indicators for each major category of resources used, (e.g. machinery and equipment; human resources; facility and environment; transport; communication systems; etc.) to determine the effective use of such resources.

Þ Where the resource planning process is performed off-site (e.g. at head-office), your QMS must include the off-site processes within your QMS and ensure that such processes comply with TS 16949 requirements. Evidence of the off-site facility’s compliance may include - a copy of their TS 16949 certification; results of their internal audits to TS 16949; auditing the outsourced facility; etc. The expectation is to flow down to the off-site facility, the relevant TS 16949 requirements that you would have to implement, had you carried out the process at your own facility.

6.2 Human Resources (HR)
6.2.1 General
Personnel performing work affecting product quality shall be competent on basis of appropriate education, training, skills and experience

6.2.2 Competence, Awareness and Training
Your organization shall:
a) Determine the necessary competence for personnel performing work affecting product
    quality
b) Provide training (or take other actions) to satisfy these competency needs
c) Evaluate the effectiveness of the actions taken
d) Ensure employees are aware of the relevance & importance of their activities & how they
    contribute to achieving quality objectives
e) Maintain appropriate records of education, training, skills, and experience

6.2.2.1 Product Design Skills
• Design and development personnel with product design responsibility shall be competent
   to achieve design requirements and are skilled in applicable tools & techniques.
• Your organization shall identify these tools and techniques.

6.2.2.2 Training
• You shall establish and maintain documented procedures for identifying training needs
   and achieving competence of all personnel performing work affecting product quality.
• Personnel performing specific assigned tasks shall be qualified and focused on satisfying
   customer requirements.

Note 1 This applies to employees at all levels of the organization having an effect on quality.

Note 2 An example of customer specific requirements is the application of digitized mathematically based data.

6.2.2.3 Training on the job
• You shall provide on the job training for personnel in any new or modified job.
• You shall provide on the job training for contract or agency personnel.
• Inform personnel whose work can affect quality, the consequences to the customer of
   nonconformity to quality requirements

6.2.2.4 Motivation & empowerment - your organization shall have processes that:
• Motivate employees to achieve quality objectives
• Make continual improvements
• Create an environment that promotes innovation
• Promote quality & technological awareness throughout the whole organization
• Measure the extent to which its personnel are aware of the relevance and importance of
   their work and their contribution to achieving quality objectives (see 6.2.2.d)

Key Explanation Points and Tips:
Þ You will recall under clause 5.1e top management is responsible for ensuring the availability of resources which includes HR. Clause 5.5.1 requires top management to define the organization and its responsibilities and authorities. Clause 6.1 required that adequate resources (e.g. HR) be determined and provided. And here in clause 6.2 the specific requirements for controlling HR are defined.

Þ Planning for HR process controls requires having a documented procedure that defines or references - competency criteria; skills evaluation; identification of training needs; types of training; provision of training; how training effectiveness is evaluated; methods to communicate awareness of the importance of quality requirements and meeting quality objectives, to all employees.

Þ Criteria for competency must be developed based on appropriate education, skills, training and experience for activities, tasks, functions and processes. The level and detail of such qualifications will depend upon the complexity of product, process, technology and customer and regulatory requirements.

Þ It is up to your organization to determine the necessary criteria for the various functions and activities affecting product and QMS. A “Skills Matrix” is a useful tool used by organizations to determine and manage the competency levels required by different activities and functions.

Þ The competency criteria for personnel with responsibility for design and development must be defined as well as the specific tools and techniques they need to use. These may include - computer-aided design (CAD); design for manufacturing (DFM); design for assembly (DFA); design of experiments (DOE); etc. For a full list of these tools, refer to the IATF TS 16949:2002 guidance document.

Þ Organizations undergo significant changes through growth or decline, acquisitions, new technology and new products and processes, Also, many organizations are now outsourcing their production labor to save on payroll costs and benefits. Labor related nonconformities can easily arise in such cases. Planning for your HR process must ensure that contract and agency personnel performing work affecting product quality have adequate competency and training. Appropriate records must be kept of such training.

Þ You must determine the scope and duration for effective on the job training for product related work. This training must be provided to all full-time as well as contract and agency personnel performing such work. They must also be informed of what nonconformities may arise and the consequence to the (internal and external) customer. Appropriate records must be kept of such training as well as training effectiveness. Review specific requirements for training at OEM customer or IATF websites.

Þ Quality awareness must be focused on meeting customer and regulatory requirements. The process to measure employee awareness of the importance of their work in meeting customer requirements and quality objectives may include the use of - department or process quality metrics; involvement in quality planning; ongoing training programs; zero defect programs; product workshops; use of cross-functional teams; etc.

Þ QMS personnel must be motivated to achieve the organizations quality objective. The process to motivate employees and promote quality awareness and innovation may include the use of - cross-functional teams; employee surveys; employee recognition awards; improvement suggestions; poster campaigns; quality circles; workshops; etc.

Þ You must determine and keep appropriate records of education; training; skills and experience. These records must demonstrate the effective operation of HR process controls (see first sentence of clause 4.2.4 quality records).

Þ Performance indicators to measure the effectiveness of the HR process in determining competency and training needs of the workforce, could include - employee turnover; employee complaints; number of instances unqualified personnel were found performing QMS activity; number of instances competency criteria were not met; and number of instances no training or competency records maintained; etc.

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

6.4.1Personal 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.