Introduction
Manufacturing businesses often undergo rigorous audits to ensure their compliance with quality management standards and regulations. These audits are conducted by lead auditors who meticulously evaluate various processes, systems, and documentation to identify any non-conformances. Non-conformances are deviations from established standards or procedures that can affect product quality, safety, and overall business performance. In this blog post, we will explore some of the most common non-conformances raised during manufacturing audits, provide examples, and suggest ways to handle them while offering guidance on presenting evidence to address these issues.
Inadequate Documentation
One of the most frequently encountered non-conformances in manufacturing audits is inadequate documentation. This includes missing or incomplete records related to quality control, production processes, and equipment maintenance. For instance, a manufacturer might lack updated procedures for handling critical materials, leading to potential risks.
How to Address:
Audit teams should request missing documentation and provide a clear timeline for submission.
The auditee should update and maintain comprehensive records of all critical processes, equipment maintenance, and quality control procedures.
Evidence to Present:
Revised and updated documentation that addresses the identified gaps.
A record of training and awareness programs to ensure staff understand the importance of accurate documentation.
When an auditor identifies inadequate documentation as a non-conformance during a manufacturing audit, they typically provide evidence to support their findings. Here are some examples of non-conformance evidence that an auditor might present to the auditee:
Missing Standard Operating Procedures (SOPs):
Auditor identifies a critical manufacturing process with missing or outdated SOPs.
Evidence: A list of processes without corresponding SOPs, highlighting the gaps in documentation.
2. Incomplete Recordkeeping:
Auditor finds incomplete batch records for a production run, missing critical data such as batch numbers, production dates, or material traceability.
Evidence: Copies of incomplete batch records with specific sections highlighted as missing or incomplete.
3. Outdated Work Instructions:
Auditor observes that work instructions for operating machinery have not been updated in several years, potentially leading to unsafe practices or product defects.
Evidence: A comparison between the last updated date on work instructions and the current date of the audit.
4. Lack of Document Control:
Auditor discovers that documents lack proper version control or approval signatures, raising concerns about the integrity of the documentation system.
Evidence: Documentation with missing or inconsistent version control, along with unsigned or unauthorized revisions.
5. Unclear Document Retrieval:
Auditor notices that employees struggle to locate critical documents in a timely manner, hindering efficient operations.
Evidence: Interviews with employees highlighting difficulties in finding necessary documents and records.
6. Missing Training Records:
Auditor identifies that there are no records indicating which employees have received training on specific procedures, raising concerns about staff competence.
Evidence: A list of procedures with no corresponding training records or a lack of training matrices for critical processes.
7. Inconsistent Documentation Practices:
Auditor observes variations in how employees document similar processes, which can lead to confusion and errors.
Evidence: Examples of inconsistent documentation practices, such as variations in format, terminology, or content.
8. Lack of Document Review and Approval:
Auditor finds documents that have not undergone the required review and approval process before implementation, potentially leading to unauthorized changes or errors.
Evidence: Documentation with no evidence of review and approval signatures or dates.
9. Unavailability of Regulatory Documents:
Auditor notes that the auditee is unable to provide necessary regulatory documents, such as safety data sheets (SDS) for chemicals used in production.
Evidence: A list of missing regulatory documents and communication logs showing requests for these documents.
10. Inadequate Change Control Records:
Auditor identifies instances where changes to critical processes or procedures have been made without proper change control documentation.
Evidence: A record of process changes without corresponding change control documentation or approval records.
When presenting such evidence to the auditee, the auditor's goal is to clearly demonstrate the discrepancies and gaps in documentation that constitute non-conformances. This evidence is crucial for the auditee to understand the deficiencies and take corrective actions to address them effectively.
Lack of Employee Training
Auditors often find non-conformances related to employee training. This includes employees not adequately trained to perform their tasks, particularly in roles that involve critical quality control measures. An example could be an employee operating complex machinery without proper training, risking product defects.
How to Address:
The auditee should establish a comprehensive training program.
Conduct regular assessments and evaluations to ensure employees have the necessary skills and knowledge for their roles.
Evidence to Present:
Training records, including the dates of training, content covered, and the employees who participated.
Documentation of assessments to demonstrate employees' competency.
When an auditor identifies non-conformances related to employee training during a manufacturing audit, they provide evidence to support their findings. Here are some examples of evidence that an auditor might present to the auditee:
1. Training Records:
Auditor requests training records for specific employees or job roles.
Evidence: Copies of training records that demonstrate which employees received training, when it was conducted, and what topics were covered.
2. Training Schedules:
Auditor examines training schedules to ensure that training sessions are planned and conducted regularly.
Evidence: Training schedules showing the dates and times of training sessions and the employees scheduled to attend.
3. Training Evaluation Forms:
Auditor reviews employee evaluations after training to assess their comprehension and competence.
Evidence: Completed training evaluation forms with ratings and comments from both trainers and trainees.
4. Competency Assessments:
Auditor checks if competency assessments are conducted to verify that employees can perform their tasks effectively.
Evidence: Records of competency assessments with documented results and any corrective actions taken if deficiencies were identified.
5. Training Materials:
Auditor examines training materials to ensure they are up-to-date and aligned with the organization's procedures and standards.
Evidence: Copies of training materials, including presentations, manuals, and handouts, along with dates of the last updates.
6. Training Attendance Logs:
Auditor reviews attendance logs for training sessions to confirm that all relevant employees attended required training.
Evidence: Attendance logs or sign-in sheets for training sessions, showing which employees were present.
7. Certification Records:
Auditor checks if employees have the necessary certifications for specific job roles.
Evidence: Copies of certification records or licenses, indicating that employees meet the qualifications for their roles.
8. Training Needs Analysis:
Auditor assesses whether a training needs analysis has been conducted to identify gaps in employee skills and knowledge.
Evidence: Documentation of a training needs analysis, including identified gaps and a plan to address them.
9. Training Records for New Hires:
Auditor verifies that new employees receive adequate training during onboarding.
Evidence: Onboarding training records for new hires, demonstrating that they received orientation and job-specific training.
10. Training Effectiveness Metrics:
Auditor examines metrics related to training effectiveness, such as reduced error rates or improved employee performance.
Evidence: Metrics and reports showing the impact of training on employee performance and product quality.
When presenting this evidence to the auditee, the auditor aims to show whether the organization's training processes are effective, well-documented, and compliant with regulatory requirements and industry standards. This evidence serves as the basis for discussions and recommendations for improving the training program to ensure that employees have the necessary skills and knowledge to perform their roles effectively.
Non-Conforming Products
The production of non-conforming products is a significant concern during manufacturing audits. This occurs when products fail to meet specified quality standards, leading to potential customer complaints and recalls. For example, a manufacturer may produce goods that do not meet size or weight specifications.
How to Address:
Implement a robust quality control system to identify and segregate non-conforming products.
Establish procedures for investigating and addressing the root causes of non-conformance to prevent recurrence.
Evidence to Present:
Records of quality control checks and inspections.
Documentation of investigations into non-conforming products and corrective actions taken.
When an auditor identifies non-conforming products during a manufacturing audit, they provide evidence to support their findings. Here are some examples of evidence that an auditor might present to the auditee:
Non-Conforming Product Reports (NCRs):
Auditor reviews NCRs generated during the audit or from previous production runs.
Evidence: Copies of NCRs detailing the non-conforming product, including product identification, the reason for non-conformance, and any corrective actions taken.
2. Production Records:
Auditor examines production records to identify instances where products deviate from specified quality standards.
Evidence: Production records indicating deviations from quality standards, such as measurements outside acceptable tolerances or deviations in product specifications.
3. Inspection and Testing Results:
Auditor checks results of quality inspections and product testing.
Evidence: Inspection and testing reports showing failed or out-of-specification results for specific products or batches.
4. Scrap and Rework Records:
Auditor assesses records of scrapped products or products requiring rework.
Evidence: Records of scrapped or reworked products, including the reasons for scrap or rework and actions taken to address the issues.
5. Material Traceability:
Auditor reviews material traceability records to identify non-conforming materials used in production.
Evidence: Material traceability records showing the source of materials and any discrepancies in material quality.
6. Customer Complaints:
Auditor investigates customer complaints related to product quality.
Evidence: Copies of customer complaint reports, including details of the complaints, investigations, and resolutions.
7. Corrective and Preventive Actions (CAPAs):
Auditor examines CAPAs related to non-conforming products.
Evidence: Records of CAPAs initiated in response to non-conforming products, including action plans, implementation status, and effectiveness assessments.
8. Non-Conforming Product Review Meetings:
Auditor assesses the minutes and records of non-conforming product review meetings.
Evidence: Minutes of meetings where non-conforming products were discussed, including decisions made and actions assigned.
9. Root Cause Analysis Reports:
Auditor checks for root cause analysis reports conducted to determine the underlying causes of non-conforming products.
Evidence: Root cause analysis reports with identified root causes, contributing factors, and corrective actions.
10. Disposition Records:
Auditor reviews records detailing how non-conforming products were dispositioned (e.g., scrapped, reworked, or released).
Evidence: Disposition records indicating the final disposition of non-conforming products and the responsible parties.
When presenting this evidence to the auditee, the auditor aims to demonstrate the existence of non-conforming products, the processes in place to address them, and the effectiveness of corrective and preventive actions. The evidence serves as the basis for discussions and recommendations to improve product quality and reduce non-conforming products in the manufacturing process.
Inadequate supplier management
Manufacturers rely on suppliers for raw materials and components. Non-conformances related to supplier management can lead to issues in the manufacturing process. For instance, a supplier may consistently deliver subpar materials, affecting product quality.
How to Address:
Develop a comprehensive supplier management program that includes supplier evaluation and performance monitoring.
Establish clear communication channels with suppliers to address any issues promptly.
Evidence to Present:
Supplier evaluation reports, including performance metrics.
Records of communication with suppliers regarding quality concerns and corrective actions taken.
When an auditor identifies non-conformances related to inadequate supplier management during a manufacturing audit, they provide evidence to support their findings. Here are some examples of evidence that an auditor might present to the auditee:
Supplier Evaluation Records:
Auditor reviews supplier evaluation records to assess how suppliers are assessed and monitored.
Evidence: Supplier evaluation reports, including performance metrics, quality assessments, and any identified issues or concerns.
2. Supplier Audit Reports:
Auditor conducts supplier audits or reviews previous audit reports to identify deficiencies.
Evidence: Supplier audit reports highlighting findings, non-conformances, and recommendations for improvement.
3. Non-Conforming Material Reports from Suppliers:
Auditor identifies instances where suppliers have delivered non-conforming materials or products.
Evidence: Copies of non-conforming material reports received from suppliers, including details of the non-conformances and actions taken.
4. Supplier Communication Records:
Auditor examines records of communication with suppliers regarding quality concerns or changes in requirements.
Evidence: Records of emails, letters, or meeting minutes documenting communication with suppliers about quality issues and resolutions.
5. Supplier Qualification Documentation:
Auditor assesses whether suppliers have been properly qualified and approved before becoming part of the supply chain.
Evidence: Documentation demonstrating supplier qualification, including completed questionnaires, quality certifications, and approval records.
6. Supplier Performance Scorecards:
Auditor reviews supplier performance scorecards to evaluate supplier performance over time.
Evidence: Supplier performance scorecards showing ratings for key performance indicators (KPIs) and trends in supplier performance.
7. Supplier Corrective Action Requests (SCARs):
Auditor examines SCARs initiated in response to supplier-related issues.
Evidence: Records of SCARs, including the reasons for initiation, corrective actions requested from suppliers, and resolution status.
8. Inventory Management Records:
Auditor checks inventory management records for discrepancies related to supplier deliveries or stockouts.
Evidence: Inventory management records indicating fluctuations in inventory levels or delays in receiving materials from suppliers.
9. Supplier Contracts and Agreements:
Auditor assesses supplier contracts and agreements to ensure they contain clear quality and performance requirements.
Evidence: Copies of supplier contracts, purchase orders, or agreements specifying quality standards and expectations.
10. Supplier Training Records:
Auditor investigates whether suppliers receive training on the organization's quality and safety requirements.
Evidence: Records of supplier training sessions or certifications confirming supplier personnel have received required training.
When presenting this evidence to the auditee, the auditor aims to demonstrate deficiencies in supplier management processes, potential risks, and areas for improvement. The evidence serves as the basis for discussions and recommendations to enhance supplier management practices and ensure a more reliable and quality-assured supply chain.
Equipment Calibration and Maintenance
Auditors often identify non-conformances related to equipment calibration and maintenance. Equipment that is not properly calibrated or maintained can result in inaccuracies and production delays. For instance, a measurement instrument used in quality control may be out of calibration, leading to incorrect measurements.
How to Address:
Implement a regular equipment calibration and maintenance schedule.
Ensure that employees responsible for equipment maintenance are adequately trained.
Evidence to Present:
Records of equipment calibration and maintenance activities, including dates and results.
Training records for maintenance personnel.
When an auditor identifies non-conformances related to equipment calibration and maintenance during a manufacturing audit, they provide evidence to support their findings. Here are some examples of evidence that an auditor might present to the auditee:
Calibration Records:
Auditor examines calibration records for critical equipment and instruments to verify that they are up-to-date.
Evidence: Calibration certificates and records showing the date of the last calibration, calibration results, and any adjustments made.
2. Maintenance Logs:
Auditor reviews maintenance logs to ensure that equipment is being regularly inspected and maintained according to the schedule.
Evidence: Maintenance logs with entries for equipment inspections, maintenance tasks performed, and dates of maintenance activities.
3. Equipment Downtime Reports:
Auditor identifies instances where equipment downtime has caused production delays due to calibration or maintenance issues.
Evidence: Downtime reports indicating the reasons for equipment downtime, duration, and impact on production.
4. Out-of-Tolerance Reports:
Auditor finds records of equipment that has gone out of tolerance, potentially affecting product quality.
Evidence: Out-of-tolerance reports detailing which equipment exceeded acceptable tolerance limits, the impact on production, and corrective actions taken.
5. Calibration Certificates:
Auditor checks whether certificates of calibration for critical equipment are readily available and up-to-date.
Evidence: Copies of calibration certificates with information about the calibration provider, equipment details, and calibration results.
6. Equipment Calibration Labels:
Auditor observes equipment to confirm that calibration labels are affixed and up-to-date.
Evidence: Photographs or documented observations of equipment with calibration labels indicating the date of the last calibration.
7. Preventive Maintenance Records:
Auditor examines records of preventive maintenance tasks carried out to prevent equipment breakdowns.
Evidence: Preventive maintenance records outlining scheduled tasks, completion dates, and any identified issues or repairs.
8. Equipment Validation Reports:
Auditor assesses whether equipment used in critical processes has been properly validated.
Evidence: Equipment validation reports with documented validation protocols, results, and acceptance criteria.
9. Maintenance Training Records:
Auditor investigates whether maintenance personnel are adequately trained to perform equipment maintenance.
Evidence: Records of maintenance personnel training, including training content, dates, and certifications.
10. Equipment Failure Analysis:
Auditor reviews records of equipment failures and the subsequent analysis to identify root causes.
Evidence: Failure analysis reports showing the investigation process, identified root causes, and corrective actions taken to prevent recurrence.
When presenting this evidence to the auditee, the auditor aims to highlight deficiencies in equipment calibration and maintenance processes, potential risks to product quality and production efficiency, and opportunities for improvement. The evidence serves as the basis for discussions and recommendations to enhance equipment management practices and ensure equipment reliability and accuracy.
Conclusion
Manufacturing audits play a vital role in ensuring product quality and regulatory compliance. Identifying and addressing non-conformances is essential for the long-term success of any manufacturing business. By addressing common non-conformances effectively and providing evidence to support corrective actions, manufacturers can improve their processes, enhance product quality, and maintain a positive reputation in the market. Remember that a proactive approach to addressing non-conformances is key to preventing them from recurring in the future.
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