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6.2 Human Resources (HR)
6.2.1 General
Personnel performing work affecting product quality must be competent on basis of appropriate education, training, skills and experience
6.2.2 Competence, Awareness and Training
Your organization must:
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
Key Explanation Points and Tips:
ÞYou 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.
ÞPlanning for HR process controls must include determining - 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.
ÞAlthough training may end up being the best solution, don’t overlook other actions, such as, changing processes, improving procedures, rotating jobs, outsourcing, or recruiting fully training people.
ÞCriteria 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, skills, training and experience will depend upon the complexity of product, process, technology and customer and regulatory requirements.
ÞIt is up to your organization to determine the necessary criteria for the various functions and activities affecting product and QMS based on these factors. A “Skills Matrix” is a useful tool used by organizations to determine and manage the competency levels required by different activities and functions.
ÞOrganizations 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.
ÞQuality awareness must be focused on meeting customer and regulatory requirements. The process to promote quality awareness may include the use of methods such as - cross-functional teams; involvement in quality planning; quality circles; improvement suggestions; product workshops; zero defect programs, product review checklist; etc.
ÞQMS personnel must be motivated to achieve the organizations quality objectives. The process to motivate employees may include the use of methods such as - employee recognition awards; ongoing training programs; performance reviews, employee surveys; poster campaigns; etc,.
ÞYou 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).
ÞPerformance 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.
