Environment for the operation of processes 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. 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. 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. Performance indicators to measure the effectiveness of processes 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.
Clause 184.108.40.206 Environment for the operation of processes
In addition the the requirements given in ISO 9001:2015 Clause 7.1.4 Environment for the operation of processes, in Clause 220.127.116.11 states that the organization must maintain its premises in a state of order, cleanliness, and repair that is consistent with the product and manufacturing process needs.
The environment for the operation of processes is an important aspect within the IATF 16949 standard, which is a quality management system requirement for automotive suppliers. The standard recognizes the significance of providing a suitable work environment for the effective operation of processes and the well-being of employees. Here are some key considerations related to the work environment within the context of IATF 16949:
- Health and Safety: The organization is required to establish and maintain a safe and healthy work environment. This includes identifying and addressing potential hazards, providing appropriate safety equipment, implementing safety procedures, and ensuring compliance with applicable health and safety regulations.
- Ergonomics: The standard emphasizes the importance of ergonomics to minimize the risk of work-related injuries and promote employee well-being. Organizations should consider ergonomic principles when designing workstations, tools, and equipment to optimize efficiency and reduce physical strain on employees.
- Cleanliness and Order: The work environment should be clean, organized, and well-maintained. This helps to prevent contamination, ensure efficient operations, and create a positive atmosphere for employees. Adequate measures should be taken to manage waste, cleanliness, and sanitation as required by the processes and regulatory requirements.
- Noise and Vibration Control: If the processes involve high levels of noise or vibration, the organization should implement appropriate control measures to mitigate their impact. This may include using noise-damping materials, providing hearing protection, or implementing vibration isolation techniques to protect the health and comfort of employees.
- Temperature and Humidity: Depending on the nature of the processes, maintaining suitable temperature and humidity levels may be necessary. Extreme variations in temperature or humidity can affect both product quality and employee comfort, so organizations should ensure that the work environment is appropriately controlled.
- Employee Well-being: The organization should promote employee well-being by addressing factors such as employee comfort, adequate lighting, ventilation, and access to amenities such as restrooms and break areas. This can contribute to employee satisfaction, productivity, and overall morale.
To maintain premises in a state of order, cleanliness, and repair consistent with the product and manufacturing process needs, consider the following practices:
- Regular Cleaning and Housekeeping: Implement a regular cleaning schedule to ensure that all areas of the premises are cleaned and maintained. This includes floors, walls, ceilings, equipment, storage areas, and common spaces. Assign responsibilities to specific individuals or teams to ensure accountability for cleanliness.
- Establish Cleaning Procedures: Develop and document clear cleaning procedures that outline the methods, frequency, and responsibilities for cleaning different areas and equipment. Ensure that employees are trained on these procedures and understand their roles in maintaining cleanliness.
- Implement 5S Methodology: Adopt the principles of 5S (Sort, Set in Order, Shine, Standardize, Sustain) to organize and maintain the work environment effectively. This methodology promotes a systematic approach to workplace organization, cleanliness, and visual management.
- Preventive Maintenance: Establish a preventive maintenance program to proactively address repair and maintenance needs. Regularly inspect equipment, machinery, utilities, and infrastructure to identify potential issues and address them promptly. This helps to prevent breakdowns, minimize downtime, and ensure a safe working environment.
- Equipment Calibration and Verification: Regularly calibrate and verify equipment to ensure accurate and reliable operation. This includes measuring devices, testing equipment, and any machinery that affects product quality or process control. Keep records of calibration activities to demonstrate compliance and traceability.
- Risk Assessment and Mitigation: Conduct periodic risk assessments to identify potential hazards or risks that may impact the premises or manufacturing processes. Implement appropriate measures to mitigate these risks, such as installing safety systems, using protective equipment, or implementing process controls.
- Training and Employee Engagement: Provide training to employees on the importance of maintaining a clean and organized work environment. Foster a culture of cleanliness and orderliness by encouraging employee involvement and ownership in maintaining the premises. Regularly communicate expectations and provide feedback to reinforce good practices.
- Continuous Improvement: Establish a culture of continuous improvement where employees are encouraged to identify opportunities for enhancing cleanliness, organization, and repair. Implement suggestions and monitor the effectiveness of any improvements made.