ISO 9001:2015 Clause 8.1 Operational planning and control

ISO 9001:2015 Requirements

The organization shall plan, implement and control the processes needed to meet the requirements for the provision of products and services, and to implement the actions determined in Clause 6, by:

1. determining the requirements for the products and services;
2. establishing criteria for:
   • the processes;
   • the acceptance of products and services;
3. determining the resources needed to achieve conformity to the product and service requirements;
4. implementing control of the processes in accordance with the criteria;
5. determining and keeping documented information to the extent necessary:
   • to have confidence that the processes have been carried out as planned;
   • to demonstrate the conformity of products and services to their requirements.

NOTE “Keeping” implies both the maintaining and the retaining of documented information.
The output of this planning shall be suitable for the organization’s operations. The organization shall control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary. The organization shall ensure that outsourced processes are controlled.

1) The organization shall plan, implement and control the processes needed to meet the requirements for the provision of products and services,

Operational planning and control involves setting objectives and targets; planning and implementing activities; Monitoring and controlling activities; Continuous improvement. At its core, operational planning and control are about ensuring that an organisation’s resources are best used to achieve its objectives. To do this, an organisation needs to have a clear understanding of its processes, products, and services. It also needs to have a clear understanding of the market and the customer needs. With this information, an organisation can create a plan for how to best use its resources to achieve its objectives. Once the plan is in place, the organisation needs to monitor and control its operations to ensure that it is achieving its objectives. The operational planning and control process is an ongoing cycle that helps organisations to continuously improve their performance. Operational planning and Control is a dynamic process that is constantly evolving in response to changes in the external environment and the needs of the organisation. It is an essential part of any organisation’s overall strategy and helps to ensure that the organisation can respond effectively to opportunities and challenges. Operational Planning and Control is important because it provides a framework for making decisions about the allocation of resources and the implementation of activities. It helps managers to ensure that an organisation can achieve its objectives by identifying and responding to opportunities and threats in the environment. It helps managers to monitor progress towards objectives and take corrective action if necessary. This can help to avoid or minimise disruptions to operations and keep projects on track. It helps to improve communication between different departments and levels within an organisation. It can also help to create a sense of ownership and responsibility among employees for the achievement of organisational goals. Here’s a step-by-step guide on how an organization can effectively perform operational planning and control within its QMS:

1. Define Quality Objectives: Start by establishing clear and measurable quality objectives. These objectives should align with your organization’s strategic goals and reflect what you aim to achieve in terms of quality.
2. Identify Processes: Identify the key processes within your organization that directly impact product or service quality. These could include design and development, manufacturing, procurement, customer service, and more.
3. Process Mapping: Create process maps or flowcharts for each identified process. Document the inputs, activities, outputs, and interactions within each process.
4. Risk Assessment: Conduct a risk assessment for each process to identify potential risks and opportunities related to quality. Consider factors such as resource availability, process capabilities, and external influences.
5. Set Quality Requirements: Define the quality requirements for each process, including specifications, standards, and customer expectations. Ensure that these requirements are clear and well-communicated to relevant personnel.
6. Resource Allocation: Allocate the necessary resources, including personnel, equipment, materials, and technology, to support the execution of each process effectively.
7. Document Procedures and Work Instructions: Develop documented procedures and work instructions that detail how each process should be performed to meet quality requirements. Ensure that these documents are readily available to employees.
8. Training and Competence: Provide training to employees to ensure they are competent in executing their roles within each process. Regularly assess and update their competence as needed.
9. Monitoring and Measurement: Implement monitoring and measurement processes to track the performance of each process. This may involve collecting data, conducting inspections, and performing tests at specified intervals.
10. Data Analysis: Analyze the data collected during monitoring and measurement to identify trends, patterns, and potential areas for improvement.
11. Corrective and Preventive Actions: Implement corrective actions to address nonconformities and prevent their recurrence. Develop preventive actions to proactively mitigate potential issues.
12. Change Management: Establish a change management process to evaluate and control changes to processes, procedures, or resources that could impact quality.
13. Supplier and Contractor Control: If applicable, ensure that suppliers and contractors are also subject to quality controls to maintain the integrity of your processes and the products or services they provide.
14. Documented Information: Maintain documented information that provides evidence of effective operational planning and control, including records of monitoring, measurement, corrective actions, and changes.
15. Management Review: Periodically review the performance of your operational planning and control processes during management review meetings. Use these reviews to make informed decisions and drive continuous improvement.
16. Communication: Foster clear and effective communication channels among employees, departments, and stakeholders regarding operational planning, control activities, and quality objectives.
17. Continuous Improvement: Continuously seek opportunities to improve your operational planning and control processes by using data-driven decision-making and feedback from stakeholders.

2) Determining the requirements for the products and services

The requirements for products and services provided by an organisation shall be determined and managed. Determination of the requirements for products and services is a key activity of the organisation that needs to be understood, controlled, and improved. Determining the requirements for products and services is a fundamental step in operational planning and control within a Quality Management System (QMS). This step ensures that the organization fully understands what needs to be delivered to meet customer expectations and conform to quality standards. Here’s how to go about it:

1. Customer Requirements: Begin by gathering and documenting all customer requirements. This includes specifications, standards, expectations, and any unique demands or preferences communicated by customers.
2. Regulatory and Legal Requirements: Identify and document all applicable regulatory and legal requirements that pertain to the products or services you offer. These may include safety standards, environmental regulations, industry-specific certifications, and more.
3. Organizational Standards and Policies: Determine any internal quality standards, policies, and procedures that apply to the products or services. This includes your organization’s own quality requirements and specifications.
4. Stakeholder Expectations: Consider the expectations and requirements of other relevant stakeholders, such as suppliers, partners, and employees, that may influence the products or services you provide.
5. Industry Standards and Best Practices: Stay informed about industry standards, best practices, and benchmarks that are relevant to your products or services. These can provide valuable guidance on quality requirements.
6. Product or Service Design Inputs: If applicable, involve design and development teams to provide input on the requirements for new products or services. Ensure that design inputs are aligned with customer needs and quality objectives.
7. Risk Assessment: Conduct a risk assessment to identify potential risks and uncertainties associated with the requirements. This helps in addressing and mitigating quality-related risks.
8. Document Requirements: Document all identified requirements in a clear and structured manner. Use a standardized format or template to ensure consistency and easy reference.
9. Validation of Requirements: Validate the requirements with stakeholders, including customers, to confirm that they accurately reflect their needs and expectations. Make necessary adjustments based on feedback.
10. Change Management: Establish a process for managing changes to requirements, whether they come from customers, regulatory updates, or other sources. Ensure that changes are properly assessed and documented.
11. Communication: Communicate the requirements effectively to all relevant parties within the organization, including those responsible for executing the processes that deliver the products or services.
12. Monitoring and Review: Continuously monitor and review the requirements to ensure they remain up-to-date and relevant. Regularly assess whether the products or services are meeting these requirements.
13. Feedback Loop: Create a feedback loop with customers and stakeholders to gather feedback on the delivered products or services. Use this feedback to make improvements and adjustments to requirements as needed.

By determining and documenting the requirements for products and services as part of your operational planning and control processes, you ensure that your organization is well-equipped to meet customer expectations, comply with regulations, and maintain a high level of quality in its offerings. This is a fundamental aspect of effective quality management within a QMS.

3) Establishing criteria for the processes and the acceptance of products and services;

Establishing clear criteria for processes and the acceptance of products and services is a crucial part of operational planning and control within a Quality Management System (QMS). These criteria serve as benchmarks to ensure that processes are performed consistently and that the resulting products and services meet the required quality standards. Here’s how to establish these criteria effectively:

1. Process Criteria: Define specific criteria for each process that are essential for achieving the desired outcomes. Process criteria may include factors such as process inputs, activities, controls, and performance indicators.
2. Acceptance Criteria for Products and Services: Clearly outline the acceptance criteria for products and services. These criteria should specify the minimum quality and performance standards that must be met for a product or service to be considered acceptable.
3. Quality Standards and Specifications: Refer to relevant quality standards, industry specifications, and customer requirements to establish process and acceptance criteria. These external sources provide valuable guidance on what is expected.
4. Measurement and Testing Requirements: Identify the measurement and testing methods that will be used to assess whether the process criteria and acceptance criteria have been met. This includes specifying sampling plans, inspection methods, and measurement techniques.
5. Tolerances and Limits: Define acceptable tolerances and limits for critical parameters and characteristics. These provide a range within which variations are permissible without impacting product or service quality.
6. Customer Requirements: Incorporate customer-specific requirements into your criteria. These may include unique features, performance expectations, or quality metrics that are important to your customers.
7. Regulatory Compliance: Ensure that your criteria align with relevant regulatory and legal requirements. This is particularly important in industries with strict compliance obligations.
8. Documented Procedures:Develop documented procedures and work instructions that provide step-by-step guidance on how processes should be executed to meet the established criteria.
9. Verification and Validation Plans:Create verification and validation plans for processes and products/services. These plans should outline how and when verification and validation activities will be conducted to confirm compliance with the criteria.
10. Criteria Communication: Communicate the established criteria clearly to all relevant personnel involved in the processes. Ensure that employees understand the importance of adhering to these criteria.
11. Monitoring and Measurement: Implement monitoring and measurement processes to track the performance of processes and the quality of products and services. Regularly assess whether criteria are being met.
12. Record Keeping: Maintain records of monitoring and measurement results, including any deviations or nonconformities. This documentation provides evidence of adherence to the criteria.
13. Continuous Improvement: Continuously review and refine the criteria based on feedback, data analysis, and changes in customer needs or industry standards. Use lessons learned to enhance criteria over time.
14. Change Control: Establish a change control process to manage updates or revisions to criteria. Ensure that changes are properly assessed, approved, and communicated.

By establishing clear and well-defined criteria for processes and the acceptance of products and services, organizations can consistently deliver high-quality results, meet customer expectations, and maintain compliance with relevant standards and regulations. This contributes to effective operational planning and control within a QMS.

4) Determining the resources needed to achieve conformity to the product and service requirements

Determining the resources needed to achieve conformity to product and service requirements is a vital part of operational planning and control within a Quality Management System (QMS). Adequate resource allocation ensures that your organization can consistently produce products and services that meet quality standards and customer expectations. Here’s how to effectively determine and allocate the necessary resources:

1. Resource Identification: Begin by identifying the specific resources required for each process involved in producing products or delivering services. Resources can include personnel, equipment, materials, technology, facilities, and more.
2. Resource Evaluation: Assess the current availability and capability of the identified resources. Consider factors such as their capacity, efficiency, and suitability for the tasks they will perform.
3. Resource Planning: Develop a resource plan that outlines how each resource will be allocated to various processes. Ensure that the plan aligns with the organization’s objectives and quality requirements.
4. Personnel Allocation: Assign skilled and trained personnel to appropriate roles within processes. Ensure that employees have the necessary training and competence to perform their tasks effectively.
5. Equipment and Technology: Ensure that equipment and technology are maintained, calibrated, and in good working condition. Regularly review and upgrade equipment as needed to meet quality requirements.
6. Material Sourcing and Management: Establish processes for sourcing, receiving, storing, and handling materials and components. Ensure that materials meet quality specifications and are used efficiently.
7. Capacity Planning:
   • Analyze the capacity of resources to determine if additional resources are needed during peak demand periods. Plan for contingencies to handle fluctuations in workload.
8. Supplier Relationships: Collaborate with suppliers and contractors to ensure a reliable supply of materials, components, or services. Verify that external suppliers meet quality and delivery standards.
9. Technology and Tools: Utilize technology and tools, such as quality management software or data analytics, to optimize resource allocation and enhance process efficiency.
10. Resource Monitoring and Performance Measurement: Implement monitoring and performance measurement systems to assess how well resources are utilized and whether they contribute to meeting quality objectives.
11. Risk Assessment:Conduct risk assessments to identify potential resource-related risks that could impact the achievement of product and service conformity. Develop mitigation plans for high-priority risks.
12. Resource Optimization: Continuously seek opportunities to optimize resource utilization and reduce waste. This includes minimizing resource downtime and enhancing resource efficiency.
13. Communication and Collaboration: Foster clear communication and collaboration among departments, teams, and suppliers to ensure effective resource allocation and adherence to quality requirements.
14. Change Management: Establish a change control process to assess and manage changes to resource allocation plans. Ensure that changes are properly evaluated, approved, and communicated.
15. Continuous Improvement: Encourage a culture of continuous improvement to regularly review and enhance resource allocation strategies based on data-driven insights and feedback.

By determining and allocating the necessary resources effectively, organizations can enhance their ability to consistently achieve conformity to product and service requirements, meet customer expectations, and maintain compliance with quality standards within their QMS.

5) Implementing control of the processes in accordance with the criteria;

Implementing control of processes in accordance with established criteria is a critical aspect of operational planning and control within a Quality Management System (QMS). This ensures that processes are executed consistently and that the resulting products and services meet the required quality standards. Here’s how to effectively implement control of processes:

1. Understand the Criteria: Ensure that all personnel involved in the process understand the established criteria, including quality standards, specifications, and customer requirements.
2. Documented Procedures: Develop and maintain documented procedures and work instructions that outline how the process should be executed to meet the established criteria. These documents serve as guides for employees.
3. Training and Competence: Provide training to employees to ensure they are competent in performing their roles within the process. Training should cover not only the technical aspects but also an understanding of the criteria and quality expectations.
4. Resource Allocation: Allocate the necessary resources, including personnel, equipment, materials, and technology, to support the execution of the process effectively.
5. Monitoring and Measurement: Implement monitoring and measurement processes to track the performance of the process. This may involve collecting data, conducting inspections, and performing tests at specified intervals.
6. Verification and Validation: Carry out verification and validation activities as outlined in the verification and validation plans. Confirm that the process meets the established criteria and quality standards.
7. Tolerance and Control Limits: Pay close attention to tolerance and control limits for critical parameters and characteristics. Ensure that variations are within acceptable limits to maintain product or service quality.
8. Feedback and Corrective Actions: Establish a feedback loop to capture information on deviations or nonconformities. Implement corrective actions promptly to address any issues that may arise during the process.
9. Change Control: Implement a change control process to assess and manage any changes to the process or its criteria. Ensure that changes are properly evaluated and approved.
10. Communication: Foster clear and effective communication among employees involved in the process. Encourage reporting of issues, concerns, and opportunities for improvement.
11. Continuous Improvement: Encourage a culture of continuous improvement within the organization. Use data and feedback to identify areas where the process can be enhanced and streamlined.
12. Record Keeping: Maintain records of monitoring, measurement results, corrective actions, and any changes related to the process. These records provide evidence of compliance with the established criteria.
13. External Audits and Inspections: Be prepared for external audits and inspections to assess the effectiveness of process controls and adherence to quality standards.
14. Management Review: Include the review of process performance and adherence to criteria as part of management review meetings. Use these reviews to make informed decisions and set objectives for improvement.
15. Supplier and Contractor Control: If applicable, ensure that suppliers and contractors involved in the process also adhere to the established criteria. This helps maintain the integrity of the process and the products or services they provide.

By implementing control of processes in alignment with the established criteria, organizations can consistently produce products and services that meet or exceed quality requirements, customer expectations, and regulatory standards. This is a fundamental component of effective operational planning and control within a QMS.

6) Determining and keeping documented information to the extent necessary to have confidence that the processes have been carried out as planned and to demonstrate the conformity of products and services to their requirements

Here are the key documents and records typically needed for compliance with this clause:

Documents:

1. Process Documentation:Documented procedures and work instructions that detail how specific processes within the organization are planned, executed, controlled, and monitored.
2. Resource Planning Documents: Documents outlining the organization’s resource planning strategies, including human resources, equipment, materials, and technology, to support operational processes effectively.
3. Change Control Procedures: Procedures that define how changes to processes, documents, and records are assessed, authorized, implemented, and communicated.
4. Risk Assessment and Management Documents: Documents related to risk assessment and management processes, including risk identification, analysis, and mitigation plans. These documents help ensure that risks to the effectiveness of operational processes are adequately addressed.
5. Supplier and Contractor Management Procedures (if applicable): Procedures that outline how suppliers and contractors are assessed, selected, and managed to ensure they meet quality and conformity requirements.

Records:

1. Monitoring and Measurement Records: Records of monitoring and measurement activities, including data related to process performance, product and service conformity, and quality objectives. These records demonstrate that processes are being effectively controlled.
2. Records of Corrective Actions and Preventive Actions: Records of corrective actions taken to address nonconformities and prevent their recurrence. These records demonstrate that issues are being addressed promptly and effectively.
3. Records of Change Control: Records that document changes to processes, procedures, or documents, including the reasons for changes, approvals, and implementation details.
4. Resource Allocation and Utilization Records: Records related to the allocation and utilization of resources, such as personnel schedules, equipment maintenance logs, and material inventory records.
5. Records of Risk Assessments: Records of risk assessments conducted for various processes, including risk identification, analysis, and mitigation plans.
6. Supplier and Contractor Evaluation Records (if applicable): Records of supplier and contractor evaluations, assessments, and performance reviews, including any actions taken based on these assessments.
7. Management Review Records: Records of management review meetings, including meeting minutes, action items, and decisions related to process performance and improvement.
8. Records of Training and Competence Assessment: Records of employee training, qualifications, and competence assessments related to operational processes.
9. Records of Process Performance Improvements: Records demonstrating continuous improvement efforts within operational processes, including the implementation of corrective and preventive actions.

These documents and records are critical for demonstrating compliance with ISO 9001:2015 Clause 8.1 and for ensuring effective operational planning and control within a Quality Management System. They provide evidence of how processes are planned, executed, monitored, and improved to achieve conformity to product and service requirements and meet quality objectives.

7) The output of this planning shall be suitable for the organization’s operations.

The output of operational planning should be tailored to be suitable for the organization’s specific operations. This means that the planning process should result in plans and strategies that align with the organization’s unique needs, goals, and circumstances. Here’s why this is important and how to achieve it:

1. Alignment with Organizational Objectives: Operational plans should be closely aligned with the organization’s strategic objectives. They should support the overarching goals and mission of the organization.
2. Customization for Different Processes: Recognize that different operational processes within the organization may have varying requirements and constraints. The output of operational planning should be customized to address the specific needs of each process.
3. Resource Allocation: Ensure that the allocation of resources, including personnel, equipment, materials, and technology, is in line with the organization’s operational capabilities and constraints.
4. Risk Management: Develop plans that consider the unique risks and challenges associated with the organization’s operations. Risk mitigation strategies should be tailored to address these specific risks.
5. Scalability and Flexibility: Plan for scalability and flexibility in operations. The output of operational planning should allow for adjustments and adaptations as the organization grows or responds to changing market conditions.
6. Compliance and Quality: Ensure that operational plans take into account compliance with regulatory requirements, quality standards, and customer expectations specific to the organization’s industry or sector.
7. Resource Efficiency: Strive for resource efficiency by optimizing processes and resource allocation to minimize waste and improve productivity.
8. Communication and Engagement: Engage relevant stakeholders within the organization in the planning process. Seek input from teams, departments, and individuals directly involved in the operations to ensure that plans are practical and achievable.
9. Clear Objectives and Key Performance Indicators (KPIs): Set clear objectives and KPIs for each operational process. These should be designed to measure performance and progress toward organizational goals.
10. Continuous Improvement: Embed a culture of continuous improvement within the organization’s operations. Regularly review and refine operational plans based on data-driven insights and feedback.
11. Monitoring and Review: Implement processes for monitoring and reviewing the execution of operational plans. Regularly assess whether plans are achieving the desired outcomes and make adjustments as needed.
12. Documentation and Communication: Document operational plans and ensure that they are communicated effectively to relevant personnel. This ensures that everyone understands their roles and responsibilities.
13. Feedback and Adaptation: Encourage feedback from employees and teams involved in the operations. Use this feedback to adapt and improve operational plans over time.

By tailoring the output of operational planning to suit the organization’s operations and context, an organization can enhance its ability to achieve its objectives, maintain operational efficiency, and respond effectively to both challenges and opportunities. This alignment is essential for the success and sustainability of the organization.

8) The organization shall control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary.

Controlling planned changes and reviewing the consequences of unintended changes is a critical aspect of effective Quality Management System (QMS) implementation. This process ensures that changes to processes, procedures, or other aspects of the organization’s operations are managed in a controlled and systematic manner. Here’s how to approach this requirement:

1. Change Management Process: Establish a formal change management process within your organization. This process should define how changes are initiated, assessed, approved, implemented, and reviewed. It should cover planned changes (intentional changes) as well as unintended changes (unforeseen issues or deviations).
2. Change Request Initiation: Anyone within the organization should be able to initiate a change request. Encourage employees to report issues, suggest improvements, or request changes when they encounter situations that may affect product quality, safety, or efficiency.
3. Change Evaluation: When a change request is received, assess its impact on the organization’s processes, products, or services. Evaluate the potential risks and benefits associated with the change.
4. Change Authorization: Changes should be authorized by individuals or teams with the appropriate authority and expertise to make informed decisions. Clearly define the approval process and criteria for change authorization.
5. Documentation and Communication: Document all change requests, including the rationale for the change, proposed actions, and authorization details. Communicate the approved changes to relevant stakeholders, ensuring that everyone affected is aware of the upcoming modifications.
6. Risk Assessment: Conduct a risk assessment for planned changes to identify potential adverse effects. Consider how the change may impact product quality, compliance with standards, customer satisfaction, and other critical factors.
7. Unintended Change Review: Regularly monitor and review processes to detect unintended changes or deviations. Investigate and document the root causes of these unintended changes, whether they result from human error, equipment malfunction, or other factors.
8. Corrective and Preventive Actions: When unintended changes are detected, take immediate corrective actions to address any adverse effects. Additionally, consider implementing preventive actions to reduce the likelihood of similar issues occurring in the future.
9. Verification and Validation: Verify and validate that the changes, whether planned or unintended, have achieved the desired outcomes and have not adversely affected product quality or safety.
10. Documentation of Change Outcomes: Maintain records of the outcomes of both planned and unintended changes. This documentation should include details of any corrective or preventive actions taken.
11. Continuous Improvement: Continuously assess the effectiveness of your change management process. Use data and feedback to refine the process and make improvements over time.
12. Training and Awareness: Ensure that employees are trained on the change management process and are aware of their responsibilities in reporting and managing changes.
13. Communication: Foster open communication channels so that employees feel comfortable reporting unintended changes or issues that may arise during operations.

By implementing a robust change management process that covers both planned and unintended changes, organizations can proactively address issues, minimize adverse effects, and continuously improve their QMS and operational performance. This contributes to the organization’s ability to maintain quality, consistency, and compliance with standards and customer expectations.

10) The organization shall ensure that outsourced processes are controlled.

Ensuring the control of outsourced processes is a critical component of effective Quality Management System (QMS) implementation, as organizations often rely on external suppliers or service providers to deliver certain aspects of their products or services. Controlling outsourced processes helps maintain quality, consistency, and compliance with the organization’s standards and customer requirements. Here’s how to ensure the control of outsourced processes:

1. Identification of Outsourced Processes: Begin by identifying which processes or parts of processes are outsourced. Clearly define the scope of work that is being performed by external suppliers or service providers.
2. Supplier Selection and Evaluation: Establish a robust supplier selection and evaluation process. Assess potential suppliers based on their ability to meet quality and performance requirements, compliance with standards, financial stability, and reputation.
3. Contractual Agreements: Develop clear and comprehensive contractual agreements with outsourced partners. These agreements should outline roles, responsibilities, quality expectations, delivery schedules, and any other critical terms and conditions.
4. Quality Requirements: Clearly communicate your organization’s quality requirements and standards to outsourced partners. Provide them with documentation detailing the quality specifications and criteria that must be met.
5. Quality Audits and Assessments: Conduct regular quality audits and assessments of your outsourced partners. Evaluate their processes, systems, and performance against established criteria. This may involve on-site audits or remote assessments.
6. Performance Monitoring: Implement a system for ongoing performance monitoring of outsourced processes. Track key performance indicators (KPIs) to ensure that quality and delivery targets are being met.
7. Communication and Collaboration: Foster open communication and collaboration between your organization and outsourced partners. Maintain regular contact to address issues, provide feedback, and ensure alignment with quality objectives.
8. Change Control: Establish a change control process that covers changes to outsourced processes. Ensure that any modifications or updates are communicated, evaluated, and approved in accordance with your QMS requirements.
9. Nonconformity Management: Develop procedures for managing nonconformities that may arise from outsourced processes. Define the process for reporting, investigating, and resolving nonconformities in collaboration with the supplier.
10. Traceability and Documentation: Maintain clear traceability of products or services provided by outsourced partners. Keep records of the products or services received, inspected, and accepted.
11. Training and Competence: Ensure that outsourced partners’ employees who are involved in your processes are adequately trained and competent to perform their roles effectively.
12. Contingency Planning: Develop contingency plans to address any disruptions in outsourced processes. This includes identifying alternative suppliers or processes to mitigate risks.
13. Legal and Regulatory Compliance: Ensure that outsourced partners comply with all relevant legal and regulatory requirements applicable to your industry and products or services.
14. Continuous Improvement: Continuously assess the performance of outsourced processes and the effectiveness of your control measures. Seek opportunities for improvement and work collaboratively with partners to implement enhancements.

By implementing robust control measures for outsourced processes, organizations can minimize risks, maintain product or service quality, and ensure compliance with standards and customer expectations. Effective control of outsourced processes is essential for the overall success of the QMS and the organization’s ability to deliver high-quality products or services.

Example of Operational Planning and Control Procedure

Objective: To ensure that operational processes are planned, executed, and controlled to meet product and service quality requirements and achieve organizational objectives.

Scope: This procedure applies to all operational processes within the organization.

Responsibilities:

• Top Management: Responsible for overall QMS effectiveness and providing necessary resources.
• Quality Manager: Responsible for overseeing the implementation and compliance of this procedure.
• Process Owners: Responsible for planning and controlling their respective operational processes.
• Employees: Responsible for following the procedures and contributing to process improvements.

Procedure:

1. Process Identification and Documentation:
   • Process owners identify and document the operational processes within their areas of responsibility.
   • Each documented process includes a process description, objectives, inputs, outputs, controls, and key performance indicators (KPIs).
2. Process Planning:
   • Process owners develop process plans that outline the specific activities, resources, and timelines required to achieve process objectives.
   • Consideration is given to customer requirements, regulatory requirements, and QMS standards.
3. Resource Allocation:
   • Process owners identify and allocate the necessary resources, including personnel, equipment, facilities, and materials, to execute the process according to the plan.
4. Risk Assessment:
   • A risk assessment is conducted to identify potential risks and opportunities associated with the operational process.
   • Risk mitigation and contingency plans are developed as needed.
5. Monitoring and Measurement:
   • KPIs and performance indicators are established to monitor the effectiveness and efficiency of the operational process.
   • Monitoring frequency and responsible parties are defined.
6. Process Execution:
   • Personnel responsible for the process execute activities according to the documented process plan.
   • They ensure compliance with documented procedures, quality standards, and customer requirements.
7. Nonconformance Handling:
   • Any deviations from the process plan, including nonconforming outputs, are promptly identified, documented, and reported to the responsible personnel.
   • Corrective and preventive actions are initiated, when necessary.
8. Process Control and Records:
   • Process owners maintain control over the process, ensuring that it operates within defined parameters.
   • All records related to process execution, monitoring, and nonconformance handling are accurately documented and retained.
9. Process Review and Improvement:
   • Regular process reviews are conducted to assess performance against objectives and KPIs.
   • Opportunities for improvement are identified and corrective actions are taken to enhance process effectiveness.
10. Management Review:
    • Top management reviews the overall performance of operational processes as part of the management review process.
    • Resource allocation and strategic decisions are adjusted as needed to support process improvements and QMS objectives.
11. Communication:
    • Process owners communicate process changes, improvements, and performance updates to relevant stakeholders, including employees, customers, and suppliers.
12. Documentation and Records:
    • All process-related documentation and records are controlled, retained, and made available as necessary to support decision-making and audits.
13. Training:
    • Personnel involved in operational processes receive training as required to perform their roles effectively and in compliance with the QMS.
14. Review and Revision:
    • This procedure is periodically reviewed and revised to ensure its ongoing effectiveness and alignment with organizational needs and objectives.