The organization shall implement production and service provision under controlled conditions.
Controlled conditions shall include, as applicable:
- the availability of documented information that defines:
- the characteristics of the products to be produced, the services to be provided, or the activities to be performed;
- the results to be achieved;
- the availability and use of suitable monitoring and measuring resources;
- the implementation of monitoring and measurement activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for products and services, have been met;
- the use of suitable infrastructure and environment for the operation of processes;
- the appointment of competent persons, including any required qualification;
- the validation, and periodic re-validation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement;
- the implementation of actions to prevent human error;
- the implementation of release, delivery and post-delivery activities.
1) The organization shall implement production and service provision under controlled conditions.
This clause requires an organization to design controlled conditions under which the production and service provision should take place. Businesses should develop, conduct, control and monitor production processes to ensure parts manufactured conform to specifications. This includes documented instructions that define the production activities, approval of processes and equipment and any changes to those processes and equipment, monitoring and control of process parameters, and component characteristics during production. Making use of documented procedures, work instructions, specifications, drawings, reference materials, suitable equipment and specific monitoring and measurement devices; where the absence of such could affect quality, your organization should employ process controls, which are consistent and appropriate for the operations being conducted. Your organization should ensure adequate equipment is available and adequate for the manufacture of products to meet specifications. This includes ensuring equipment is maintained periodically, documenting activities performed and by whom and when the activites are performed. To ensure that processes are consistently controlled, an organization can follow these key steps:
- Define and Document Processes: Identify and define all the processes involved in production and service provision. This includes subprocesses and related activities. Document these processes, including procedures, work instructions, and process maps, detailing the steps to be followed and the desired outcomes.
- Establish Clear Quality Objectives and Requirements: Clearly define quality objectives for each process, including product or service specifications, customer requirements, and any regulatory or legal requirements. Communicate these objectives and requirements to all relevant personnel.
- Implement Process Controls: Develop and implement controls and checkpoints at critical points in the processes to ensure that they are carried out as planned. Specify the methods, criteria, and standards to be used for monitoring and measuring process performance and product/service quality.
- Employee Training and Competence: Ensure that employees involved in production and service provision are adequately trained and possess the necessary skills and competence to perform their tasks effectively. Regularly assess and verify employee competence and provide additional training as needed.
- Equipment and Resource Management: Maintain equipment and resources (tools, machinery, software, etc.) in good working order to prevent unexpected failures or deviations from controlled conditions. Implement a schedule for equipment maintenance, calibration, and verification.
- Change Management: Establish a formal change control process to manage and document any changes to processes, materials, equipment, or personnel. Ensure that changes are assessed for potential impacts on controlled conditions and are implemented with proper authorization and oversight.
- Monitoring and Measurement: Continuously monitor and measure key process parameters and product/service characteristics to ensure they are within acceptable limits. Document and record the results of monitoring and measurement activities.
- Document Control: Establish a document control system to manage and maintain up-to-date process documentation, including procedures, work instructions, and records. Ensure that all relevant personnel have access to the latest versions of documents.
- Corrective and Preventive Actions: Implement processes for addressing non-conformities and deviations from controlled conditions promptly. Take corrective actions to eliminate the root causes of issues and prevent their recurrence.
- Management Review: Regularly review the effectiveness of controlled conditions during management review meetings. Use these reviews to identify opportunities for improvement and make necessary adjustments to processes.
- Risk Management: Identify and assess risks associated with production and service provision and implement risk mitigation strategies. Regularly review and update risk assessments as needed.
- Internal Auditing: Conduct regular internal audits to verify that controlled conditions are being followed and are effective. Use audit findings to drive improvements in the QMS.
- Customer Feedback and Satisfaction: Collect and analyze customer feedback to identify areas for improvement in controlled conditions. Use customer satisfaction data to measure the effectiveness of controlled conditions.
By systematically following these steps and continually monitoring and improving the processes, an organization can ensure that its production and service provision is carried out under controlled conditions as required by ISO 9001:2015. This approach helps maintain product/service quality, customer satisfaction, and overall organizational performance.
2) The availability of documented information that defines the characteristics of the products to be produced, the services to be provided, or the activities
to be performed;
It emphasizes the importance of having documented information that defines the characteristics of the products, services, or activities to be performed. This documentation is essential for maintaining consistency, meeting customer requirements, and ensuring effective quality management. Here’s how an organization can ensure the availability of this documented information:
- Product, Service, or Activity Specifications: Clearly define and document the specifications, characteristics, and requirements for each product, service, or activity that the organization provides. This documentation should include details such as design specifications, technical specifications, performance criteria, dimensions, materials, and any other relevant information.
- Quality Plans and Procedures: Develop quality plans and procedures that outline the steps and processes required to meet the defined characteristics and requirements. These documents should provide clear instructions for employees on how to perform their tasks in accordance with the specified standards.
- Product or Service Descriptions: Create descriptions or data sheets for each product or service, which can serve as reference documents for employees and customers. These descriptions should include information on the intended use, features, benefits, and any special considerations.
- Work Instructions: Develop detailed work instructions that provide step-by-step guidance for carrying out specific tasks or processes.These instructions should cover critical processes that have a direct impact on product or service quality.
- Regulatory and Legal Requirements: Ensure that the documented information also includes references to relevant regulatory and legal requirements that apply to the organization’s products, services, or activities. Stay up-to-date with changes in regulations and update the documented information accordingly.
- Change Control Process: Implement a change control process to manage updates and revisions to the documented information. Ensure that changes are properly reviewed, approved, and communicated to relevant personnel.
- Documented Information Storage: Store all documented information in a controlled and accessible manner, such as in a document management system or a centralized repository. Ensure that authorized personnel can easily access and retrieve the required documents when needed.
- Training and Awareness: Train employees on the importance of using and referencing the documented information in their daily work. Foster awareness of the significance of adhering to defined characteristics and requirements.
- Review and Validation: Periodically review and validate the documented information to ensure that it remains accurate, up-to-date, and aligned with customer expectations and organizational goals.
- Auditing and Compliance: Conduct internal audits to verify that employees are following the documented information and that products, services, or activities conform to the specified characteristics. Ensure that non-conformities are addressed through corrective actions.
- Customer Communication: Share relevant portions of the documented information with customers as needed to clarify product or service specifications and to manage their expectations.
By following these steps, an organization can ensure that the documented information defining the characteristics of its products, services, or activities is readily available, up-to-date, and effectively used throughout the organization, thereby promoting quality, consistency, and customer satisfaction. Documented information related to the activities that need to be undertaken to produce the product or deliver the service should be available. This documented information should specify the results that are to be achieved. These details may typically be available in your project programs or plans. These plans or programs should be made so that they should indicate how different units interact with each other. All activities that need to be performed starting from customer delivery requirements, raw material purchase, resources required, production, storage, packaging, delivery with clearly outlined plans outlining who, what, when and how a product is made or service is delivered. The plans can also define the sequence in which material or equipment is required, measurement and monitoring tools that would be used, verification that need to be carried out, stages at which verification is done, and how problems, if any arise, would be handled, etc. For a builder, an example of documented information can be Project programmes which are updated on a two-weekly basis to show progress with the project tasks. For service delivery, if you are selling software as a service, this can be preparing a roadmap for the product and managing the backlog of tasks, or setting up epics and stories within a tool like JIRA. The level of detail that would go into such documents is decided by the organization and can be just a brief description, a process flowchart, or a detailed project plan, etc. These should be readily available to the personnel responsible for carrying out these activities. The amount of documentation required should be decided based on the complexity, size and risk involved in the work being performed. However, if a job required a particular document, for example, work instructions, these should be available and relevant.
3) The organization must ensure availability of documented information that defines the results to be achieved
Ensuring the availability of documented information that defines the results to be achieved is an essential aspect of effective quality management, as required by ISO 9001:2015. This documentation helps organizations clarify their objectives, monitor progress, and demonstrate compliance with quality standards. Here’s how an organization can ensure the availability of such documented information:
- Define Clear Objectives and Goals:Start by defining clear and specific objectives and goals for the organization, departments, projects, or processes. These objectives should be measurable, achievable, relevant, and time-bound (SMART).
- Documented Quality Policy and Objectives: Document the organization’s quality policy, which should include a commitment to meeting customer requirements, complying with relevant standards, and continually improving. Document specific quality objectives that support the organization’s quality policy.
- Performance Indicators and Metrics: Identify and document key performance indicators (KPIs) and metrics that are relevant to your objectives. Define how these KPIs will be measured, monitored, and reported.
- Targets and Thresholds: Set specific targets and thresholds for each KPI to clearly define what constitutes successful achievement. These targets should align with your objectives and be realistic and achievable.
- Strategic Plans and Action Plans: Document strategic plans that outline the long-term strategies and initiatives needed to achieve your objectives. Develop action plans that detail the specific steps, responsibilities, and timelines for reaching your goals.
- Communication and Awareness: Ensure that the documented information related to objectives, goals, KPIs, and targets is communicated to all relevant employees. Foster awareness of the importance of achieving these results and how individual roles contribute to the organization’s success.
- Monitoring and Measurement: Establish processes for monitoring and measuring performance against the defined objectives and KPIs. Regularly collect and analyze data to assess progress.
- Performance Reviews: Conduct regular performance reviews and management reviews to assess the organization’s progress in achieving its objectives. Use these reviews to identify areas for improvement and make necessary adjustments.
- Documented Information Storage: Store all documented information related to objectives, goals, KPIs, and performance in a controlled and accessible manner. Ensure that authorized personnel can easily access and retrieve this information when needed.
- Auditing and Compliance: Conduct internal audits to verify that the organization is following its documented information related to objectives and performance. Address any non-conformities through corrective actions.
- Reporting: Develop reporting mechanisms to communicate performance results to relevant stakeholders, including management, employees, and, if applicable, customers and regulators.
- Continuous Improvement: Use the results of performance monitoring and reviews to drive continuous improvement efforts. Continually assess and update objectives, targets, and actions as needed.
By following these steps, an organization can ensure the availability of documented information that defines the results to be achieved, allowing for effective management of objectives, performance, and continual improvement. This aligns with the requirements of ISO 9001:2015 and contributes to the organization’s overall success and customer satisfaction.
4) The availability and use of suitable monitoring and measuring resources
Ensuring the availability and use of suitable monitoring and measuring resources during production and servicing is crucial for maintaining product and service quality, as well as for meeting the requirements of ISO 9001:2015. Properly calibrated and maintained monitoring and measuring devices help organizations achieve accurate and reliable results. Here are steps to ensure their availability and use:
- Identify Monitoring and Measuring Devices: Identify all monitoring and measuring devices used within your production and service provision processes. This includes instruments, equipment, tools, software, and any other devices used for measurement and monitoring.
- Calibration and Verification: Establish a calibration program to ensure that all devices are regularly calibrated and verified to maintain accuracy and reliability. Maintain records of calibration activities, including dates, results, and any adjustments made.
- Selection of Suitable Devices: Ensure that the selected monitoring and measuring devices are suitable for the specific tasks and measurements required in your processes. Consider factors such as measurement range, precision, and traceability to standards.
- Validation of Software Tools: If software tools are used for measurements or data analysis, validate their accuracy and suitability for the intended purpose. Keep records of software validation activities.
- Proper Storage and Handling: Store monitoring and measuring devices in controlled environments to prevent damage or degradation. Handle devices with care to avoid physical damage or contamination.
- Maintenance and Repairs: Establish procedures for routine maintenance and repairs of monitoring and measuring devices. Keep records of maintenance and repair activities, including any replacement parts used.
- Training and Competence: Ensure that personnel responsible for using monitoring and measuring devices are trained and competent in their proper use. Provide training on device handling, maintenance, and calibration procedures.
- Records and Documentation: Maintain records of device calibrations, verification, maintenance, and usage. Ensure that these records are easily accessible and well-organized.
- Monitoring and Measurement Procedures: Develop documented procedures that specify how monitoring and measurements will be conducted using the devices. Ensure that these procedures are followed consistently.
- Risk Assessment: Identify and assess risks associated with the use of monitoring and measuring devices, including the risk of incorrect measurements. Implement controls to mitigate these risks.
- Traceability and Documentation of Measurement Results: Ensure that measurement results are documented accurately, including units of measurement, date and time, and any relevant conditions. Maintain traceability of measurements to national or international standards, where applicable.
- Auditing and Review: Conduct internal audits to verify that monitoring and measuring devices are used and maintained as per established procedures. Include device-related activities in management reviews to assess their effectiveness.
- Continuous Improvement: Use data from monitoring and measuring devices to drive continuous improvement efforts in your processes. Address any issues or non-conformities identified during measurement and monitoring.
By following these steps and maintaining a robust system for the availability and use of suitable monitoring and measuring devices, organizations can ensure the accuracy and reliability of their measurements, thereby contributing to product and service quality and compliance with ISO 9001:2015 requirements.
5) Implementation of monitoring and measurement activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for products and services, have been met;
Ensuring the implementation of monitoring and measurement activities at appropriate stages is critical for verifying that criteria for the control of processes, outputs, and acceptance criteria for products and services have been met, as required by ISO 9001:2015. Here are the key steps to achieve this:
- Define Criteria and Acceptance Criteria:Clearly define the criteria for controlling processes, outputs, and acceptance criteria for products and services. Ensure that these criteria are based on customer requirements, regulatory standards, and your organization’s quality objectives.
- Identify Appropriate Stages: Determine at which stages of the processes or product/service lifecycle monitoring and measurement activities should be implemented. Consider critical points, key process steps, and potential points of failure or variability.
- Select Monitoring and Measurement Methods: Choose appropriate monitoring and measurement methods and tools that are capable of verifying the defined criteria. Ensure that these methods are suitable for the specific processes, outputs, and products or services.
- Develop Monitoring and Measurement Plans: Create documented monitoring and measurement plans that outline when, where, and how monitoring and measurement activities will be conducted. Specify responsibilities, frequency, and sampling procedures.
- Training and Competence: Ensure that personnel responsible for conducting monitoring and measurement activities are trained and competent in the use of measurement tools and techniques. Provide ongoing training and skill development as needed.
- Implementation of Monitoring and Measurement: Execute monitoring and measurement activities as per the documented plans and procedures. Record the results of these activities, including measurements, observations, and any deviations from criteria.
- Data Analysis: Analyze the data collected during monitoring and measurement to determine whether the defined criteria and acceptance criteria have been met. Use statistical methods and data analysis techniques where applicable.
- Non-Conformance Management: Establish procedures for addressing non-conformities or deviations from criteria that are identified during monitoring and measurement. Implement corrective actions to resolve issues and prevent recurrence.
- Documentation and Records: Maintain documentation and records of monitoring and measurement activities, including the results, actions taken, and any changes to criteria or acceptance criteria. Ensure that records are easily accessible and retained for the required duration.
- Review and Verification: Periodically review the results of monitoring and measurement activities to assess process and product/service performance. Verify that criteria are consistently met and that corrective actions are effective.
- Continuous Improvement: Use the data from monitoring and measurement activities to drive continuous improvement efforts in processes and products/services. Identify opportunities for optimization and efficiency.
- Communication: Communicate the results of monitoring and measurement activities to relevant stakeholders, including management, employees, and customers when applicable.
- Management Review: Include monitoring and measurement data and related activities in management review meetings to evaluate the effectiveness of the quality management system.
By following these steps, an organization can ensure that monitoring and measurement activities are implemented at appropriate stages to verify that criteria for controlling processes and products/services have been met. This approach helps maintain product and service quality, meet customer requirements, and ensure compliance with ISO 9001:2015 requirements.
6) Monitoring and Measurement Activities.
Monitoring and measurement activities to ensure that criteria for the control of processes or outputs and acceptance criteria for products and services have been met can vary depending on the specific processes, products, or services involved. However, here are some common monitoring and measurement activities that organizations typically implement to verify compliance with these criteria:
- Inspection and Testing: Regularly inspect and test products or components to check whether they meet predefined acceptance criteria. Use standardized testing methods and equipment to ensure consistency and accuracy.
- Process Control and Monitoring: Implement process controls and monitoring to ensure that critical process parameters are within specified limits. Use statistical process control (SPC) techniques to monitor process stability and capability.
- Sampling and Sampling Plans: Develop sampling plans to systematically select and evaluate a representative sample of products or components. Determine the sample size and sampling frequency based on statistical principles and acceptable risk levels.
- Calibration and Measurement of Equipment: Regularly calibrate measurement equipment and devices to ensure accuracy. Use calibrated equipment to measure and verify product or process characteristics.
- Documented Procedures and Work Instructions: Establish documented procedures and work instructions that detail how specific processes should be performed and controlled. Ensure that employees follow these procedures during production or service provision.
- Audit and Inspection of Processes: Conduct internal audits and inspections of processes to assess compliance with documented procedures and criteria. Identify non-conformities and areas for improvement.
- Supplier and External Provider Evaluation: Monitor and evaluate the performance of suppliers and external providers to ensure that they meet specified criteria and requirements. Conduct supplier audits and assessments as necessary.
- Customer Feedback and Complaints: Collect and analyze customer feedback and complaints to identify instances where products or services did not meet acceptance criteria. Implement corrective actions to address customer concerns.
- Key Performance Indicators (KPIs): Define and track KPIs related to process and product/service performance. Set targets and thresholds for KPIs to monitor and measure against criteria.
- Data Analysis and Reporting: Analyze data collected from monitoring and measurement activities to assess process and product/service performance. Generate reports and dashboards to communicate results and trends.
- Review of Non-Conformities: Investigate and review non-conformities or deviations from criteria. Implement corrective and preventive actions to address root causes and prevent recurrence.
- Control Charts and Trend Analysis: Use control charts and trend analysis to identify variations in processes or product/service characteristics. Take corrective actions when trends indicate a shift away from acceptable criteria.
- Product or Service Reviews: Conduct periodic product or service reviews to evaluate whether they meet predefined acceptance criteria. Involve cross-functional teams to ensure a comprehensive assessment.
- Change Control and Validation: Implement change control processes to assess and validate any changes to processes, materials, or equipment to ensure they do not negatively impact acceptance criteria.
- Customer Acceptance and Sign-Off: Obtain formal acceptance or sign-off from customers or authorized representatives to confirm that products or services meet their specified criteria.
- Verification and Validation Activities: Perform verification and validation activities as required by product or service design and development processes to confirm that acceptance criteria are met.
These monitoring and measurement activities are essential for ensuring that the criteria for controlling processes or outputs and acceptance criteria for products and services are consistently met. Organizations should tailor these activities to their specific needs and document them as part of their quality management system in compliance with ISO 9001:2015 or other relevant quality standards.
7) The use of suitable infrastructure and environment for the operation of processes
Ensuring the use of suitable infrastructure and environment for the operation of processes is essential to maintain product and service quality, meet customer requirements, and comply with relevant standards, including ISO 9001:2015. Here are key steps an organization can take to fulfill this requirement:
- Identify the specific infrastructure and environmental requirements for each process within your organization. These requirements may include facilities, equipment, utilities, and the physical environment.
- Ensure that the physical facilities and workspace are designed, constructed, and maintained to support the intended processes.Address issues such as layout, space availability, cleanliness, and organization to facilitate efficient and effective operations.
- Ensure a reliable and continuous supply of utilities and services necessary for process operation, such as electricity, water, HVAC (heating, ventilation, and air conditioning), and internet connectivity.Regularly maintain and monitor these utilities to prevent disruptions.
- Procure, maintain, and calibrate equipment, machinery, and tools as required for each process.Develop maintenance schedules and conduct regular inspections to ensure proper functioning.
- Provide a safe and healthy work environment for employees and visitors by addressing safety hazards and complying with occupational health and safety regulations.Conduct risk assessments to identify and mitigate potential workplace hazards.
- Control and maintain temperature and humidity levels when necessary, especially in environments where these factors can affect product or service quality (e.g., clean-rooms, laboratories).
- Implement measures to control and prevent contamination in critical areas, such as food production facilities or clean rooms. Ensure that personnel are trained in contamination control procedures.
- Implement security measures to protect both physical assets and data integrity, including access control, surveillance, and data security protocols.
- Consider environmental sustainability in your infrastructure and operations by implementing practices that reduce environmental impact, such as energy-efficient lighting, waste reduction, and recycling programs.
- Develop and maintain emergency response plans to address situations like natural disasters, fires, and power outages.Conduct drills and training to ensure employees are familiar with emergency procedures.
- Document and maintain records related to infrastructure and environmental conditions, including maintenance logs, inspection reports, and compliance records.
- Periodically review and audit the suitability and effectiveness of your infrastructure and environmental conditions.Use findings to drive improvements and address any deficiencies.
- Ensure that your infrastructure and environmental conditions comply with applicable laws, regulations, and industry standards relevant to your business.
- Assess and monitor suppliers and contractors involved in providing and maintaining infrastructure or environmental services to ensure they meet your requirements.
By following these steps, an organization can ensure that it uses suitable infrastructure and maintains an appropriate environment for the operation of its processes. This not only helps meet quality and compliance requirements but also enhances employee safety, productivity, and overall operational efficiency.
8) The appointment of competent persons, including any required qualification
Ensuring that competent individuals with the required qualifications are involved in production or service provision is crucial for maintaining quality and meeting customer requirements. Here are steps an organization can take to ensure it has the right people in place:
- Define Job Roles and Responsibilities: Clearly define the roles and responsibilities for each position involved in production or service provision. Specify the qualifications, skills, and competencies required for each role.
- Recruitment and Selection: Implement a structured recruitment and selection process to identify and hire individuals who meet the specified qualifications and competencies. Conduct interviews, assessments, and reference checks to evaluate candidates.
- Training and Development: Provide training and development programs to enhance the skills and competencies of employees. Tailor training programs to address specific job requirements and ongoing learning needs.
- Competency Assessment: Regularly assess the competency of individuals in their respective roles to ensure they meet the required qualifications and performance standards. Use performance appraisals, skills assessments, and feedback mechanisms for evaluation.
- Certifications and Licensing: Ensure that individuals who require certifications or licenses to perform their duties obtain and maintain them. Keep records of certifications and licenses to verify compliance.
- Skills Verification:Implement processes to verify and document the skills and qualifications of employees and contractors before assigning them to specific tasks.Verify qualifications through credential checks, certifications, or testing where applicable.
- Cross-Training and Succession Planning: Develop cross-training programs to ensure that multiple employees can perform critical tasks. Establish succession plans to address the potential departure or absence of key personnel.
- Competency Records: Maintain records of employee qualifications, certifications, training, and competency assessments. Ensure that these records are readily accessible for verification.
- Continual Improvement: Periodically review and assess the competency requirements for each role to ensure they remain up-to-date and aligned with changing needs. Make adjustments to training and qualification requirements as necessary.
- Employee Engagement and Recognition: Foster a positive work environment to engage and retain competent employees. Recognize and reward employees for their contributions and achievements.
- Performance Monitoring: Regularly monitor and assess employee performance to ensure that individuals are meeting the competency requirements and contributing to quality and customer satisfaction.
- Communication and Feedback: Establish open channels of communication for employees to report concerns or provide feedback related to competency and qualifications. Use feedback to identify areas for improvement.
- External Audits and Certification: If applicable, ensure that external audits and certifications (e.g., ISO certifications) include a focus on employee competence and qualification requirements.
- Customer and Regulatory Requirements: Review and comply with customer and regulatory requirements related to employee qualifications and competency, especially in industries with strict standards.
By following these steps, an organization can effectively ensure that competent individuals with the required qualifications are involved in production or service provision. This approach not only helps meet quality standards but also promotes a culture of competence and continual improvement within the organization.
9) The validation, and periodic re-validation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement
Results of the processes should be validated wherever possible. If the product cannot be verified without damaging or destroying the product, this clause recommends that the process is initially validated and evaluated periodically. Some examples may be welding, painting, electroplating or a simple pizza delivery service where the quality of these activities may only be learned after use.However, most organizations would have some intermediate verification steps to validate the products. Validation of such services can involve conducting capability studies and inspection or testing methods to ensure the product or service meets the customer’s requirements.Here’s a step-by-step guide on how an organization can conduct validation and re-validation:
- Define Validation and Re-validation Scope: Clearly define the scope of validation and re-validation activities. Determine which manufacturing processes, equipment, and systems require validation based on their criticality and impact on product quality.
- Develop Validation and Re-validation Plans: Create comprehensive validation and re-validation plans that outline the objectives, approach, schedule, resources, responsibilities, and acceptance criteria for each activity.Ensure that these plans align with relevant industry standards, regulations, and internal quality management system requirements.
- Identify Critical Parameters and Variables: Identify critical process parameters, variables, and attributes that significantly influence product quality. Determine the measurement and control points within the process.
- Collect Relevant Data: Gather data and information needed to support the validation and re-validation processes. This may include process data, product specifications, design documentation, and risk assessments.
- Installation Qualification (IQ): Conduct an Installation Qualification to verify that equipment and systems are correctly installed, calibrated, and configured according to specifications. Document and maintain records of the installation process.
- Operational Qualification (OQ): Perform an Operational Qualification to ensure that equipment and systems operate within specified operational limits under normal conditions. Conduct tests, inspections, and performance measurements as defined in the validation plan.
- Performance Qualification (PQ): Conduct a Performance Qualification to demonstrate that the manufacturing process consistently produces products that meet acceptance criteria. Use statistical methods and sampling plans to analyze process variability and capability.
- Software Validation (If Applicable): Validate any software systems used in manufacturing processes, ensuring that they function correctly and meet specified requirements. Perform both functional and non-functional testing, and document the results.
- Cleaning Validation (If Applicable): In industries with strict cleanliness requirements (e.g., pharmaceuticals or food processing), perform cleaning validation to verify that equipment and surfaces are effectively cleaned and do not pose contamination risks.
- Re-validation and Periodic Re-assessment: – Schedule periodic re-validation activities to ensure that validated processes, equipment, and systems continue to perform as expected. – Re-assess validation status based on changes in process parameters, equipment, or other relevant factors.
- Document Validation Protocols and Reports: – Document validation protocols that outline the specific tests, measurements, procedures, and acceptance criteria for each validation activity. – Prepare validation reports summarizing the activities, results, conclusions, and any actions taken as a result of the validation process.
- Regulatory Compliance: – Ensure that all validation activities comply with relevant industry-specific regulations and standards. This is particularly important in regulated industries such as pharmaceuticals and medical devices.
- Continuous Improvement: – Use the findings from validation and re-validation activities to identify areas for improvement in your processes, systems, or equipment. – Implement corrective and preventive actions as needed to address any identified issues.
- Validation Team Training: – Ensure that personnel involved in validation and re-validation activities are adequately trained and have the necessary skills and competencies.
- Document Control: – Maintain proper document control to ensure that all validation and re-validation documentation is up-to-date and easily accessible for audits and inspections.
By following these steps, an organization can effectively conduct validation and re-validation , ensuring that production processes and equipment consistently meet quality standards and regulatory requirements. These activities are crucial for maintaining product quality, customer satisfaction, and compliance with industry standards.
10) The implementation of actions to prevent human error;
Preventing human errors during manufacturing and service provision is crucial to maintain product or service quality, safety, and efficiency. Human errors can occur at various stages of these processes, but proactive measures can help reduce the likelihood of errors and their potential impact. Here are actions an organization can take to prevent human errors:
- Employee Training and Education: Provide comprehensive training to employees to ensure they have the necessary knowledge and skills to perform their tasks correctly. Include specific training on quality standards, safety procedures, and best practices.
- Standard Operating Procedures (SOPs): Develop and implement clear and well-documented SOPs for all critical processes and tasks. Ensure that SOPs are easily accessible and regularly updated.
- Task Analysis and Risk Assessment: Conduct task analysis and risk assessments to identify potential points of failure and human error. Prioritize and address high-risk areas with additional controls.
- Error-Proofing (Poka-Yoke): Implement error-proofing mechanisms and devices to prevent common human errors. These can include physical barriers, sensors, checklists, and automated error detection systems.
- Process Redundancy and Verification: Incorporate redundant checks and verifications in critical processes to catch errors before they result in defects or safety hazards. Encourage a “double-check” culture in high-risk processes.
- Visual Controls and Signage: Use visual cues, labels, color-coding, and signage to guide employees and reduce the likelihood of mistakes. Clearly mark safety zones and critical areas.
- Clear Communication: Promote effective communication among team members to ensure that instructions and information are understood. Encourage employees to ask questions when uncertain.
- Job Rotation and Cross-Training: Implement job rotation and cross-training programs to ensure that employees have a broad understanding of various tasks. This can help reduce the risk of errors caused by fatigue or monotony.
- Checklists and Job Aids: Develop checklists, job aids, and standardized forms to guide employees through complex processes and tasks. Ensure that employees use these aids consistently.
- Continuous Improvement Culture: Foster a culture of continuous improvement where employees are encouraged to identify and report potential areas for error reduction. Implement suggestions and feedback from employees.
- Feedback and Learning from Errors: Encourage reporting of errors, near misses, and incidents. Analyze the root causes of errors and implement corrective actions to prevent their recurrence.
- Automation and Technology: Where feasible, automate processes and tasks to reduce the reliance on manual labor, which can be prone to errors. Implement technology solutions that provide real-time monitoring and error detection.
- Fatigue Management: Implement policies and practices to manage employee fatigue, especially in industries with long or irregular work hours. Encourage adequate breaks and rest periods.
- Leadership and Supervision: Provide strong leadership and supervision to ensure that employees are following procedures and best practices. Lead by example and promote a safety and quality-conscious culture.
- Audits and Inspections: Conduct regular internal audits and inspections to verify compliance with procedures and identify potential deviations or errors. Take corrective actions promptly.
- Employee Involvement: Involve employees in the decision-making process regarding process improvements and changes. Employees on the front lines often have valuable insights into error prevention.
- Regulatory Compliance: Ensure that all processes and practices comply with relevant regulatory standards and requirements, which often include guidelines for error prevention.
Preventing human errors requires a multifaceted approach that combines training, process design, technology, and a culture of continuous improvement. By implementing these actions, an organization can reduce the risk of human errors, enhance quality, and improve overall operational effectiveness.
11) the implementation of release, delivery and post-delivery activities.
Products and service release, delivery and post-delivery activities should be defined and implemented as planned. Depending on the product or service you deliver, this could be an email sent to the customer, or this can involve multiple steps of packaging, transportation, shipping, etc. During the implementation of release, delivery, and post-delivery activities, organizations must establish controls to ensure that products or services are delivered to customers in accordance with their requirements and expectations. These controls help maintain product or service quality, customer satisfaction, and compliance with quality management standards like ISO 9001:2015. Here are some key control measures that organizations should take during these activities:
- Verification and Validation: Conduct thorough verification and validation activities to ensure that the product or service meets the specified requirements and standards before release.
- Documented Release Criteria: Define and document clear criteria for releasing products or services. These criteria should include quality checks, inspections, and approvals.
- Approval Process: Implement an approval process where authorized personnel review and approve the release of products or services. Ensure that only those meeting the defined criteria are released.
- Change Control: Ensure that any changes to products or services, including last-minute alterations, are documented, evaluated, and approved before release.
- Traceability: Maintain traceability records that link products or services to their respective requirements, design specifications, and any applicable regulatory or customer standards.
- Packaging and Labeling: Properly package and label products or services, including relevant documentation and instructions for use or installation.
- Shipping and Transport: Implement controls to ensure that products are properly packaged, labeled, and transported to prevent damage, contamination, or loss during delivery.
- Delivery Confirmation: Use tracking systems or delivery confirmations to ensure that products or services reach the intended destination.
- Documentation: Provide accurate and complete documentation, including invoices, packing lists, and certificates of conformity, with the delivered products or services.
- Customer Communication: Maintain open and effective communication with customers regarding delivery schedules, delays, and any other relevant information.
- Compliance with Regulatory Requirements: Ensure that products or services comply with all applicable regulatory requirements and standards during delivery.
- Customer Feedback: Establish mechanisms for collecting and documenting customer feedback regarding product or service performance, satisfaction, and any issues encountered.
- Complaint Handling: Implement a structured process for receiving, documenting, investigating, and resolving customer complaints or non-conformities related to delivered products or services.
- Warranty and Support: Provide warranty information and post-delivery support to address any defects, malfunctions, or customer inquiries promptly.
- Product and Service Updates: Monitor and implement updates or improvements to products or services based on customer feedback and performance data.
- Record Keeping: Maintain records of post-delivery activities, including customer interactions, complaints, and any corrective or preventive actions taken.
- Continuous Improvement: Use data from post-delivery activities to drive continuous improvement efforts in processes, products, and services.
- Training and Awareness: Ensure that employees involved in post-delivery activities are trained and aware of the importance of maintaining customer satisfaction and addressing issues effectively.
- Regulatory Compliance: Continuously monitor and ensure compliance with regulatory requirements and standards related to post-delivery activities.
By implementing these control measures, organizations can effectively manage the release, delivery, and post-delivery stages of their products or services. These measures help ensure customer satisfaction, maintain product or service quality, and align with ISO 9001:2015 and other relevant quality management standards.
Example of Procedure for Control of Production and Service Provision
Objective: This procedure outlines the steps and controls necessary to ensure that all production and service provision activities are carried out in accordance with specified requirements and standards, including customer requirements and applicable regulations.
Scope: This procedure applies to all production and service provision processes within the organization.
- The [Quality Manager/Process Owner] is responsible for overseeing the implementation of this procedure.
- [Production/Service] Supervisors are responsible for ensuring compliance with this procedure within their respective areas.
- All employees involved in production and service provision activities must adhere to this procedure.
1. Planning and Review:
- Before production or service provision begins, review and verify the requirements specified in customer orders, contracts, and relevant documentation.
- Ensure that necessary resources, including materials, equipment, and personnel, are available and ready for use.
2. Work Instructions:
- Develop and maintain documented work instructions for each specific production or service provision process.
- Work instructions should detail step-by-step procedures, including safety precautions, quality checks, and any specific requirements.
3. Verification of Equipment and Tools:
- Prior to use, verify that all equipment, machinery, tools, and measuring devices are calibrated, maintained, and in good working condition.
- Perform equipment checks according to the [Calibration and Maintenance Procedure].
4. Personnel Training and Competence:
- Ensure that personnel involved in production and service provision are adequately trained, qualified, and competent for their assigned tasks.
- Maintain training records and conduct periodic competency assessments.
5. Material and Component Control:
- Ensure that all materials, components, and parts used in production or service provision are properly identified, inspected, and verified for compliance with specifications.
- Implement controls to prevent mix-ups, contamination, or damage to materials.
6. Process Execution:
- Follow the documented work instructions and procedures for each production or service provision process.
- Monitor and record process parameters, measurements, and any deviations from the specified requirements.
7. Inspection and Testing:
- Conduct in-process inspections and testing as required by the work instructions and quality plans.
- Document inspection results and address any non-conformities.
8. Traceability and Record Keeping:
- Maintain records that demonstrate traceability of products or services to their specific requirements, including batch/lot numbers, dates, and personnel involved.
- Retain records in accordance with the [Document Control and Record Retention Procedure].
9. Non-Conformance Handling:
- If non-conformities are identified during production or service provision, follow the [Non-Conformance Management Procedure] to address and resolve issues.
10. Final Inspection and Verification: – Conduct a final inspection or verification step to ensure that products or services meet all specified requirements and acceptance criteria.
11. Packaging and Delivery: – Properly package products or prepare services for delivery to customers, ensuring that they are protected from damage and contamination. – Use appropriate labeling and documentation.
12. Customer Communication: – Maintain open communication with customers regarding any changes, delays, or issues related to production or service provision.
13. Continuous Improvement: – Use data from production and service provision activities to drive continuous improvement efforts, identify areas for optimization, and prevent recurrence of non-conformities.
14. Review and Approval: – All completed production and service provision activities should be reviewed and approved by the [Quality Manager/Process Owner] or designated personnel.
15. Document Control: – Maintain controlled copies of all relevant documents, including work instructions, quality plans, and records, in accordance with the [Document Control Procedure].
16. Compliance with Regulatory Requirements: – Ensure that all production and service provision activities comply with relevant industry standards, regulations, and customer-specific requirements.
17. Auditing and Monitoring: – Conduct periodic internal audits and performance monitoring to assess compliance with this procedure and identify opportunities for improvement.
18. Reporting: – Report any critical issues, deviations, or non-conformities to management and initiate corrective actions as necessary.
19. Document Retention: – Retain production and service provision records as per the organization’s [Document Control and Record Retention Procedure].
20. Training and Awareness: – Ensure that all employees involved in production and service provision are aware of this procedure and receive appropriate training.
21. Review and Revision: – Periodically review and update this procedure to ensure its continued effectiveness and relevance.
22. Approval and Revision History: – Maintain records of procedure approvals and revisions.