The standard requires that Verification of job set-ups and after shutdown whenever a set-up is performed and that job instructions be available for set-up personnel or there is a planned or unplanned shutdown. Job set-ups relate to changes in tooling, equipment, materials, shifts, personnel, etc. You must determine the importance of set-ups in terms of time taken and risks related to product quality, in determining the extent of set-up verification, methods used and details of work instructions made available to set-up personnel. Tooling FMEA’s provide very useful input to determine this. Verification of job set-ups may include – data on and comparison of the last series (quality records, corrective actions); completeness of equipment and documentation for production, inspection and testing; responsibilities for release after set-up; disposition of pre-launch or set-up scrap; comparisons of last piece with specified requirements and first piece of new run, etc. Include job set-up controls in your control plans. In setting up a job prior to commencing a production run, you need to verify that all the requirements for the part are being met. You will therefore need job set-up instructions so as to ensure each time the production of a particular part commences that the process is set up against the same criteria. In addition, process parameters may change whenever there is material changeover, a job change, or if significant time periods elapse between production runs. Documentation verifying job set-ups should include documentation to perform the setup and records that demonstrate that the set-up has been performed as required. This requires that you record the parameters set and the sample size and retain the control charts used which indicate performance to be within the central third of the control limits. These records should be retained. The organization should to use statistical methods of verification during job set-up. You will need to produce more than one part to verify that the process is stable. You need to form a sample large enough to take statistical measurement. If the measurements taken on the product fall within the central third of the control limits then the set-up can be approved – if not, then adjustments should be made and further samples produced until this condition is achieved.
In the automotive industry, a planned shutdown refers to a scheduled interruption of production or manufacturing operations within a facility. This planned downtime is often scheduled well in advance to carry out essential maintenance, upgrades, retooling, or other necessary tasks. During a planned shutdown, production lines are intentionally stopped to perform tasks that are difficult or impossible to execute during regular operation. The goal of a planned shutdown is to ensure the long-term efficiency, reliability, and safety of the manufacturing processes and equipment.Planned shutdowns offer several benefits to automotive manufacturers. They allow time for preventive maintenance, which helps prevent unexpected breakdowns and reduces the risk of costly production delays. Additionally, these scheduled breaks provide an opportunity to implement process improvements, upgrade machinery, or incorporate new technologies into the production line. By carrying out such activities during planned shutdowns, automotive manufacturers can optimize their operations and enhance overall productivity.On the other hand, an unplanned shutdown, also known as an unplanned outage or unexpected downtime, refers to an unscheduled interruption of production due to unforeseen events or issues. These events can include equipment failures, supply chain disruptions, power outages, natural disasters, or unforeseen emergencies. Unplanned shutdowns can lead to significant financial losses, reduced productivity, and delays in meeting customer demands.Automotive manufacturers strive to minimize the occurrence of unplanned shutdowns through proactive maintenance practices, robust contingency plans, and risk management strategies. Regular inspections, condition monitoring, and predictive maintenance techniques are employed to identify potential equipment failures or weaknesses before they escalate into major issues. Additionally, strong supplier relationships and well-structured logistics systems help mitigate supply chain disruptions that could lead to unexpected downtime.Both planned and unplanned shutdowns are crucial aspects of the automotive industry. Planned shutdowns allow manufacturers to maintain and improve their production facilities, while efforts to minimize and manage unplanned shutdowns are critical to ensure continuous and efficient operations. Striking the right balance between planned and unplanned downtime is vital for automotive manufacturers to optimize production, enhance quality, and remain competitive in the dynamic automotive market.
Clause 8.5.1.3 Verification of job set-ups
The organization must verify job set-ups after initial run of a job, material changeover, or job change that requires a new set-up. It must maintain documented information for set-up personnel. It must use statistical methods of verification, where applicable must perform first-off/last-off part validation, as applicable; where appropriate, first-off parts should be retained for comparison with the last-off parts; where appropriate, last-off-parts should be retained for comparison with first-off parts in subsequent runs; It must retain records of process and product approval following set-up and first- off/last-off part validations.
Verification of job set-ups after the initial run of a job, material changeover, or job change that requires a new set-up is a critical step in ensuring the accuracy, quality, and efficiency of the production process. This verification process involves checking and confirming that all equipment, tools, and parameters are correctly configured for the specific job or material being processed. Here are the key steps involved in the verification of job set-ups:
1. Visual Inspection: Perform a visual inspection of the equipment, tools, and materials to ensure they are in the correct positions and aligned according to the set-up specifications. Verify that all components are present and in good condition.
2. Calibration and Measurement: Calibrate measuring instruments and devices to ensure accurate readings during the set-up verification process. Measure critical dimensions and settings to confirm they align with the required values.
3. Material Confirmation: Verify that the correct material is loaded into the machine or production line. Cross-reference the material specifications with the job order or work instructions.
4. Tooling and Fixture Check: Ensure that the appropriate tooling and fixtures are in place for the specific job or material. Check for any signs of wear or damage that could affect product quality.
5. Machine Settings and Parameters: Review and validate machine settings and parameters, such as speed, pressure, temperature, and timing. Confirm that they match the requirements specified for the job.
6. Process Verification: Conduct test runs or pilot production to verify that the process is functioning correctly and producing parts that meet the required quality standards.
7. Sample Inspection: Inspect samples produced during the initial run or changeover to verify that they meet the specified quality criteria. Compare the samples against the quality standards and make adjustments if necessary.
8. Operator Training and Familiarization: Ensure that the operators responsible for the set-up are adequately trained and familiar with the new job requirements. This includes understanding any changes in processes, materials, or equipment.
9. Documentation Review: Cross-check all relevant documentation, such as work instructions, job orders, and set-up sheets, to confirm that they reflect the latest changes and accurately guide the set-up process.
10. Feedback and Continuous Improvement: Encourage feedback from operators and production staff regarding the set-up process. Use this feedback to identify potential areas for improvement and implement corrective actions.
11. Standardized Work: Develop and maintain standardized set-up procedures to ensure consistency and reduce the likelihood of errors during the verification process.
12. Approval and Sign-off: Once the verification process is completed successfully, obtain approval and sign-off from designated personnel to confirm that the set-up is ready for production.By following these steps, manufacturers can confidently verify job set-ups after initial runs, material changeovers, or job changes, ensuring that the production process operates smoothly, efficiently, and meets the required quality standards. Proper set-up verification is crucial for minimizing downtime, reducing waste, and maximizing productivity in manufacturing operations.Regenerate
Documented information for set-up personnel.
Documented information for set-up personnel plays a crucial role in ensuring consistency, accuracy, and efficiency during the set-up process. This information serves as a reference guide and provides step-by-step instructions for set-up personnel to follow. Here are some key elements that should be included in the documented information for set-up personnel:
1. Set-up Procedures: Detailed step-by-step procedures for setting up the equipment, machinery, or production line for a specific job or product. Include clear instructions on how to adjust settings, install tooling, and prepare the materials.
2. Equipment and Tooling Information: Provide information about the equipment and tools required for the set-up, including specifications, part numbers, and maintenance requirements. This ensures that set-up personnel have the necessary resources at their disposal.
3. Material Specifications: Document the specifications of the materials to be used in the set-up, including dimensions, tolerances, and any special handling or storage instructions.
4. Safety Guidelines: Include safety instructions and precautions specific to the set-up process. This ensures that set-up personnel are aware of potential hazards and follow safety protocols during the set-up.
5. Quality Standards: Specify the quality standards and requirements that the set-up should meet. This includes tolerances, visual inspection criteria, and other quality parameters.
6. Troubleshooting and Problem-Solving Tips: Provide troubleshooting guidelines for common issues that may arise during the set-up process. Include solutions and problem-solving tips to address these issues quickly and efficiently.
7. Visual Aids and Illustrations: Incorporate visual aids such as diagrams, photographs, and charts to supplement written instructions. Visuals can help set-up personnel better understand the process and identify critical components.
8. Checklists: Include checklists that set-up personnel can use to verify that all necessary tasks have been completed. Checklists help ensure that no steps are missed during the set-up.
9. Recordkeeping Requirements: Document any data or measurements that need to be recorded during the set-up process. This information may be essential for tracking production performance and identifying trends or improvements.
10. Pre-Set-up Inspections: Include pre-set-up inspection procedures to verify that the equipment and machinery are in good working condition before starting the set-up.
11. Post-Set-up Verification: Outline the steps for verifying the set-up after completion to ensure that everything is ready for production.
12. Revision Control: Maintain a version control system for the documented set-up information to track updates and ensure that set-up personnel are using the latest and most accurate instructions.
By providing comprehensive and well-structured documented information for set-up personnel, organizations can promote consistency, reduce errors, and optimize the set-up process. This documentation is a valuable resource that empowers set-up personnel to perform their tasks efficiently and effectively, contributing to overall operational success and product quality.
Statistical method for Verification
The statistical methods of verification, particularly for first-off/last-off part validation, aim to ensure that the manufacturing process is stable, consistent, and capable of producing parts within the specified tolerances. These methods involve comparing the first part produced (first-off) and the last part produced (last-off) in a production run to assess the process’s variation and consistency. Here’s how each step of the verification process works:
- First-off/Last-off Part Validation:
- First-Off Part: The first part produced during a production run is referred to as the “first-off” part. This part is usually inspected and verified to ensure that the production process is correctly set up and capable of producing parts within the required specifications.
- Last-Off Part: The last part produced during a production run is known as the “last-off” part. It is essential to inspect and verify the last-off part to assess whether the process remained stable throughout the production run.
- Comparison of First-Off and Last-Off Parts:
- First-off parts should be retained and compared with the last-off parts produced in the same production run. This comparison helps identify any variations that may have occurred during the production process.
- If the first-off and last-off parts show consistent dimensions and meet the required specifications, it indicates that the production process is stable and capable of maintaining the required quality throughout the run.
- Retaining Last-Off Parts for Subsequent Runs:
- The last-off parts from the current production run should be retained and used as references for subsequent runs of the same job or product. These parts can be compared with the first-off parts in the next run to assess process consistency over time.
- By comparing the last-off parts from different runs with the corresponding first-off parts, manufacturers can monitor any changes or trends in the production process’s performance.
Statistical Methods:
- Statistical Process Control (SPC): SPC involves using statistical techniques to monitor and control the production process. Control charts are commonly used to analyze data from first-off and last-off parts to identify variations and trends.
- Process Capability Analysis: This analysis assesses whether the production process is capable of meeting the specified tolerances. Process capability indices like Cp, Cpk, Pp, and Ppk can be calculated and compared for the first-off and last-off parts.
- Six Sigma: Six Sigma methodologies can be applied to measure and improve process performance, aiming to minimize variations and defects.
By following these statistical methods of verification for first-off/last-off part validation, manufacturers can ensure that their production processes are stable, consistent, and capable of meeting quality requirements. These practices help identify potential issues early on, leading to improved product quality and reduced variability in the manufacturing process.
Records of process and product approval
Records of process and product approval following set-up and first-off/last-off part validations are critical documentation that demonstrates the successful completion of these verification processes. These records provide evidence that the manufacturing process is capable of producing parts within the specified tolerances and meets the required quality standards. Here are the key components of these records:
- Set-Up Approval Record:
- Date and time of the set-up completion.
- Identification of the set-up personnel who performed the task.
- Description of the set-up procedures followed.
- Verification of equipment, tooling, and materials used during the set-up.
- Any adjustments made to machine settings or parameters during the set-up.
- Pre-set-up inspections and their outcomes.
- Records of any calibration or maintenance performed on equipment or tools.
- Any issues or deviations encountered during the set-up and their resolution.
- Signature or approval of a designated authority confirming the successful completion of the set-up.
- First-Off/Last-Off Part Validation Record:
- Identification of the first-off and last-off parts produced during the production run.
- Measurement data and inspection results for the first-off and last-off parts.
- Comparison of the dimensions and quality attributes of the first-off and last-off parts.
- Any observed variations or trends between the first-off and last-off parts.
- Conclusions drawn from the comparison, including process stability and consistency.
- Statistical analyses, such as control charts or process capability indices used in the validation.
- Any actions taken based on the validation results, such as process adjustments or improvements.
- Signature or approval of a designated authority confirming the successful completion of the first-off/last-off part validation.
- Product Approval Record:
- Confirmation that the first-off parts meet the specified quality requirements.
- Approval of the first-off parts for production, indicating that the process is ready to run.
- Record of any further inspections or verification performed during the production run.
- Verification of the last-off parts for consistency with the first-off parts.
- Approval of the last-off parts for compliance with the required quality standards.
- Any notes or remarks regarding the production process or product quality.
- Signature or approval of a designated authority confirming the product’s approval for release.
These records serve as a documented trail of the set-up and verification processes, ensuring traceability, accountability, and compliance with quality management standards and regulations. They also provide valuable data for continuous improvement efforts, as trends and patterns observed during these validations can be used to identify opportunities for process optimization and defect prevention. Maintaining detailed and accurate records of process and product approval is an essential practice in maintaining consistent quality and meeting customer expectations.
8.5.1.4 Verification after shutdown
The organization shall define and implement the necessary actions to ensure product compliance with requirements after a planned or unplanned production shutdown period.
After a planned or unplanned production shutdown period, it is essential for the organization to define and implement necessary actions to ensure product compliance with requirements when production resumes. This ensures that the manufacturing process is stable, and the products meet the specified quality standards. Here are the key steps in this process:
- Post-Shutdown Inspection and Verification: Conduct thorough inspections and verifications of the equipment, machinery, and production line after the shutdown. Check for any signs of damage, wear, or deviations from the required specifications.
- Calibration and Adjustment: Calibrate measuring instruments and devices to ensure accurate readings. Make any necessary adjustments to the equipment and machinery to bring them back to their optimal operating conditions.
- Material and Inventory Check: Verify the status of materials and inventory to ensure they are in good condition and suitable for use. Check for any expired materials or potential issues in the supply chain.
- Process Restart Protocol: Develop a clear and detailed protocol for restarting the production process after the shutdown. This protocol should outline the steps to be followed, safety checks, and verification procedures.
- Operator Training and Reorientation: Provide training and reorientation to the workforce to update them on any changes in processes, materials, or equipment. Ensure that the operators are familiar with the post-shutdown requirements.
- Quality Control Checks: Perform quality control checks on the first products produced after the shutdown. Verify that they meet the required quality standards and specifications.
- Process Capability Analysis: Conduct process capability analysis to assess whether the production process is capable of meeting the specified tolerances and quality requirements.
- Corrective Actions: If any deviations or non-conformities are identified during the post-shutdown inspections, take corrective actions to address the issues and prevent their recurrence.
- Documentation and Records: Maintain detailed documentation and records of all post-shutdown actions, inspections, verifications, and quality control checks. These records provide a history of the process and help with future improvements.
- Continuous Improvement: Encourage a culture of continuous improvement. Analyze the post-shutdown process and identify opportunities for improvement to enhance production efficiency and product quality.
- Verification of Product Compliance: Ensure that the products produced after the shutdown period comply with all specified requirements, standards, and customer expectations.
By following these steps, the organization can effectively ensure product compliance with requirements after a planned or unplanned production shutdown period. This proactive approach helps minimize risks, reduces downtime, and ensures a smooth and successful resumption of production operations.
