Temporary changes of process controls refer to the intentional and planned modifications made to the existing production or service provision processes for a specific period or under unique circumstances. These changes are usually implemented to address short-term challenges or to accommodate special situations while ensuring that the overall quality and performance of the process remain within acceptable limits. Temporary changes may be necessary due to factors such as equipment maintenance, material shortages, workforce availability, or unforeseen events that temporarily impact the regular operations. During these temporary changes, organizations need to carefully assess the potential risks and impacts on product or service quality. Adequate control measures must be put in place to ensure that deviations from the standard process are limited and closely monitored. Additionally, any temporary changes should be well-documented and communicated to relevant stakeholders to maintain transparency and accountability. Once the temporary circumstances have passed or the specific period ends, the process should be reverted to its original state, and a post-change evaluation should be conducted to ensure that the intended objectives were achieved, and there were no adverse effects on product quality or customer requirements. Managing temporary changes effectively is crucial in maintaining process stability, meeting customer expectations, and preserving the organization’s reputation for delivering high-quality products or services, even in challenging or exceptional circumstances. The organization must identify, document, and maintain a list of process controls
that includes both the primary process control (example: robotic welding) and the approved back-up or alternate methods (example: manual welding). It’s NOT mandatory to have alternate process control method for each process. In the automotive industry, temporary changes of process controls can occur due to various reasons and situations. Here are some examples:
- Supplier Shortages: If a specific component or material from a critical supplier becomes temporarily unavailable due to production issues or supply chain disruptions, the automotive manufacturer may need to source alternative suppliers or substitute materials to keep the production line running. Temporary changes in the supply chain may necessitate adjustments in the manufacturing process to accommodate the new components or materials.
- Equipment Maintenance: During scheduled maintenance or unexpected breakdowns of essential production machinery, automotive manufacturers may need to use alternative equipment or production lines temporarily. This may require modifications to the manufacturing process to adapt to the capabilities and specifications of the temporary equipment.
- Seasonal Demand: Some automotive manufacturers experience seasonal variations in demand for certain vehicle models. During peak production periods, temporary changes in process controls may be implemented to increase production rates or streamline specific assembly steps to meet the higher demand.
- Prototype Development: In the development of new vehicle models or components, temporary changes in process controls are common during prototype testing and validation. Adjustments to production methods and testing procedures may be necessary to assess the performance and reliability of the prototypes before full-scale production.
- Regulatory Changes or Recalls: In response to regulatory changes or product recalls, automotive manufacturers may need to implement temporary changes in the production process to address safety or compliance concerns. These changes aim to rectify the identified issues and prevent further occurrences until a permanent solution is implemented.
- Employee Training and Skill Development: During training periods for new employees or skill development programs for existing personnel, temporary changes in process controls may be needed to ensure smooth operations while employees learn and adapt to new techniques or technologies.
- Production Line Balancing: To optimize production efficiency or address bottlenecks in the assembly line, temporary changes in process controls may be introduced to redistribute workloads and enhance overall production flow.
It is important to note that while temporary changes in process controls are sometimes necessary, careful planning, risk assessment, and monitoring are essential to ensure that the quality and safety of the final products are not compromised. Proper documentation, communication with relevant stakeholders, and post-change evaluations help maintain control and transparency throughout the temporary change process. Once the temporary situation is resolved, the processes should be reverted to their original state, and any lessons learned can be incorporated into future improvements.
Clause 8.5.6.1.1 Temporary change of process controls
The organization must identify, document, and maintain a list of process controls, including inspection, measuring, test, and error-proofing devices. The list of process control shall include the primary process controls and the approved backup or alternate methods, if back-up or alternate methods exist. The organization shall document the process that manages the use of alternate control methods. The organization shall include in this process, based on risk analysis (such as FMEA), severity, and the internal approvals to be obtained prior to production implantation of the alternate control method. Before shipping product that was inspected or tested using the alternate method, if required, the organization shall obtain approval from the customer(s). The organization shall maintain and periodically review a list of approved alternate process control methods that are referenced in the control plan. Standard work instructions shall be available for each alternate process control method. The organization shall review the operation of alternate process controls on a daily basis, at a minimum, to verify implementation of standard work with the goal to return to the standard process as defined by the control plan as soon as possible
The requirement pertains to the identification, documentation, and maintenance of a comprehensive list of process controls, including inspection, measuring, testing, and error-proofing devices used throughout the organization’s manufacturing or service provision processes. The organization must identify all process controls that are critical for ensuring product or service quality and conformity with customer requirements. This includes controls applied at different stages of production or service provision. The identified process controls must be documented, detailing their specific purposes, methods, and acceptance criteria. This documentation serves as a reference for employees involved in process execution and quality management. The organization should include in the list the inspection, measuring, and testing devices used to verify product or service characteristics. This ensures that measurements and tests are conducted accurately and consistently. Error-proofing devices, also known as poka-yoke, are mechanisms or systems designed to prevent or detect errors and defects in the production or service provision process. These devices should be identified, documented, and maintained in the list of process controls. The list should highlight the primary process controls that are routinely used in day-to-day operations to ensure product or service quality.In cases where backup or alternate methods exist for specific process controls, such as alternative inspection methods or testing procedures, the approved backups should be included in the list. The organization must ensure that the list of process controls is up-to-date, reflecting any changes or improvements to the processes and controls. Regular review and update of the list are essential to maintain accuracy and effectiveness. By maintaining a comprehensive list of process controls, the organization can improve process consistency, ensure adherence to customer requirements, and effectively manage quality throughout the production or service provision lifecycle. The organization is required to document the process based on risk analysis, such as Failure Mode and Effects Analysis (FMEA), to evaluate the severity of potential risks. This documentation includes internal approvals that must be obtained before implementing alternate control methods that manage the identified risks. Here are the key aspects of this requirement:
- Risk Analysis (FMEA): The organization should conduct a risk analysis, typically using FMEA or other appropriate risk assessment methods, to identify potential failure modes, their effects, and the severity of those effects. FMEA helps prioritize risks based on their severity and likelihood of occurrence.
- Alternate Control Methods: Based on the risk analysis, the organization may identify alternate control methods to manage or mitigate the identified risks effectively. These alternate methods could involve changes to processes, procedures, or the use of different technologies or tools.
- Severity Assessment: The severity of each identified risk is assessed, considering the potential impact on product or service quality, safety, compliance, and customer satisfaction.
- Documentation of the Process: The process for managing alternate control methods should be documented in detail. This documentation should outline the steps involved in identifying risks, evaluating severity, and selecting appropriate alternate control methods.
- Internal Approvals: Before implementing any alternate control method, the organization should obtain internal approvals from relevant stakeholders, including management, quality, engineering, and other applicable departments. These approvals ensure that the selected methods are well-considered and aligned with the organization’s objectives.
- Implementation Plan: The documentation should include an implementation plan that outlines the timeline, responsibilities, and resources required to implement the alternate control methods effectively.
- Monitoring and Verification: Once the alternate control methods are in place, the organization should monitor their effectiveness and verify their ability to manage the identified risks. This includes ongoing evaluation and measurement to ensure the desired outcomes are achieved.
- Continuous Improvement: The organization should use the feedback and data gathered from the implementation of alternate control methods to drive continuous improvement. Lessons learned can be used to enhance processes and further reduce risks.
By documenting the process based on risk analysis, severity assessment, and obtaining internal approvals for alternate control methods, the organization can make informed decisions to manage risks effectively. This systematic approach helps ensure that potential risks are adequately addressed and that product or service quality is maintained at the desired level. Additionally, the documentation serves as valuable evidence during audits and reviews, demonstrating compliance with quality management requirements.
Obtaining customer approval before shipping products that were inspected or tested using an alternate method is a critical step in the quality management process, particularly in the automotive industry. This requirement ensures that any deviations from the standard inspection or testing procedures, which might occur due to the use of alternate control methods, are communicated to the customer, and their consent is obtained before the products are delivered. By seeking customer approval, the organization demonstrates transparency and openness in its quality management process. It informs the customer about any changes in inspection or testing methods that could affect product quality or characteristics. Customers often have specific requirements and expectations for product inspection and testing. Obtaining approval ensures that the alternate method aligns with these requirements and meets the customer’s expectations. Involving the customer in the decision-making process fosters a positive relationship and increases customer satisfaction. Customers appreciate being informed about any changes that could impact the products they receive. In situations where alternate control methods are implemented due to specific circumstances or risks, customer approval provides a level of risk mitigation. The customer can assess the potential impact of the alternate method on product quality and make informed decisions accordingly. Some contracts or agreements may require prior customer approval for any changes in the inspection or testing process. Obtaining approval ensures compliance with such contractual obligations. Seeking customer approval encourages feedback and dialogue. Customers may provide valuable insights or recommendations, contributing to continuous improvement efforts. Engaging customers in the approval process fosters trust and confidence in the organization’s commitment to providing high-quality products and services. Documenting customer approvals provides traceability and serves as evidence of compliance with customer requirements during audits or reviews. Before implementing any alternate control method for inspection or testing, the organization should communicate the proposed changes to the customer, clearly explaining the reasons, potential benefits, and any implications for product quality. The customer’s response, in the form of documented approval, should be obtained and retained as part of the quality records. This process ensures that the organization and the customer are aligned in the decision-making process and ensures that products shipped using the alternate method are accepted and meet customer expectations.
Maintaining and periodically reviewing a list of approved alternate process control methods is a critical component of an effective quality management system, particularly in the automotive industry. This list ensures that the organization has a documented reference of the accepted alternate methods for process control, which are utilized when necessary and in accordance with predefined criteria. The approved list of alternate process control methods promotes consistency and standardization across the organization. It ensures that all relevant personnel are aware of the accepted methods and can apply them uniformly when required. The list helps manage potential risks associated with the use of alternate methods. By maintaining an approved list, the organization can ensure that alternate methods have been thoroughly evaluated and validated, reducing the risk of using unproven or inappropriate methods. Having an established list of approved alternate methods streamlines decision-making when facing process challenges or unexpected situations. It saves time by providing readily available options that have been vetted and accepted. The list serves as a reference for the control plan, ensuring that the plan includes the relevant and approved alternate process control methods. Periodically reviewing the list ensures that the approved alternate methods remain relevant, up-to-date, and aligned with the organization’s current processes and objectives. This review process allows for continuous improvement and the inclusion of any new, validated methods. In regulated industries like the automotive sector, maintaining an approved list of alternate methods can facilitate compliance with relevant standards and regulations. The list provides documented evidence to auditors or regulatory authorities that the organization has a structured approach to managing alternate process control methods. The list can be shared with suppliers to ensure they are aware of the approved alternate methods and can implement them when necessary. The organization should establish clear criteria and a systematic approach for approving and adding new alternate process control methods to the list. This may involve conducting risk assessments, validation trials, and obtaining internal approvals before including the methods in the list. Periodic reviews should be scheduled to assess the effectiveness and appropriateness of the approved methods. If any changes or improvements are identified during the review, they should be properly documented, and the list should be updated accordingly. By maintaining and reviewing an approved list of alternate process control methods, the organization can enhance its process management, increase agility in responding to challenges, and ensure that alternate methods are effectively integrated into the quality management system.
Standard work instructions shall be available for each alternate process control method to ensure consistency, accuracy, and uniformity in their implementation. By having detailed and well-documented instructions, employees can understand the correct steps and procedures to follow when utilizing alternate process control methods. This minimizes the risk of errors, reduces variability in outcomes, and maintains the desired level of product or service quality. Standard work instructions also serve as a reference for training new employees and provide a basis for continuous improvement efforts, as any deviations or issues can be identified, addressed, and incorporated into the instructions to enhance process effectiveness over time.
the organization’s regular review of the operation of alternate process controls is essential for maintaining process stability and returning to the standard process defined by the control plan as soon as possible. Daily reviews allow the organization to promptly detect any deviations from the standard work instructions while using alternate process controls. Early detection enables quick corrective actions to be taken before issues escalate and impact product or service quality. Verification of Implementation: Regular reviews verify that the standard work instructions for each alternate process control method are correctly implemented. This ensures that employees are adhering to the prescribed procedures, contributing to consistent and predictable outcomes. Daily reviews foster a culture of discipline and process adherence, promoting consistency in operations across different shifts and teams. This consistency is vital to maintaining product or service quality and customer satisfaction. The frequent review of alternate process controls provides opportunities for continuous improvement. Identifying recurring issues or inefficiencies allows the organization to refine the standard work instructions and optimize the use of alternate methods. Regular monitoring helps manage potential risks associated with using alternate process controls. By reviewing operations daily, the organization can mitigate the risks and prevent them from developing into larger problems. The ultimate goal of daily reviews is to return to the standard process as defined by the control plan as soon as possible. Timely identification and resolution of issues facilitate a smooth transition back to the standard process, ensuring stability and consistency in the long run. Regular reviews contribute to process stability and control, reducing the likelihood of process disruptions or non-conformances. By reviewing the operation of alternate process controls daily, the organization can proactively manage risks, maintain quality standards, and continuously improve its processes. This disciplined approach ensures that any deviations from the standard work instructions are promptly addressed, and the organization can quickly return to the established standard process to achieve optimal performance and meet customer requirements effectively.
