Operation 4 of 7

Clause 8 (Operation) emphasizes the importance of planning, controlling, and effectively executing the processes that transform inputs (resources) into outputs (products or services). This ensures that your organization consistently delivers offerings that meet customer requirements and fulfill your quality objectives.

Control of externally provided processes, products and service

• Identification of External Providers: Organizations must identify external providers whose outputs affect the quality of their products or services. This includes suppliers, subcontractors, and service providers.
• Evaluation and Selection: A process for evaluating and selecting external providers should be in place based on their ability to meet specified requirements. This involves assessing their quality management system, capabilities, and performance history.
• Information and Requirements: Clear and unambiguous information about the organization's requirements must be communicated to external providers. This includes product specifications, quality standards, and performance expectations.
• Monitoring and Evaluation: Ongoing monitoring and evaluation of external providers' performance is essential to ensure continued conformance to requirements. This involves regular performance reviews, audits, and corrective actions as needed.
• Verification of Purchased Products: Organizations must verify purchased products and services to ensure they conform to specified requirements before using or accepting them. This includes inspection, testing, and documentation.
• Control of Purchased Product: Procedures should be in place to identify, verify, and control purchased products to prevent their unintended use or release. This includes storage, handling, and traceability.
• Corrective Action: When nonconformities are identified in externally provided products or services, corrective actions must be implemented to prevent recurrence. This includes root cause analysis and effective corrective measures.

Practical Implementation

• Supplier Management: Establish a supplier management process, including supplier selection, evaluation, approval, and monitoring.
• Clear Communication: Develop clear and concise communication channels with external providers to ensure effective information exchange.
• Collaboration: Foster collaboration with external providers to improve product and service quality.
• Risk Assessment: Identify potential risks associated with external providers and implement mitigation strategies.
• Continuous Improvement: Regularly review and improve the process for controlling externally provided processes, products, and services.

By effectively managing external providers, organizations can mitigate risks, improve product quality, and enhance customer satisfaction.

Control of Externally Provided Processes, Products, and Services: Real-world Examples and Challenges

Real-world Examples

Let's explore some common scenarios where organizations rely on external providers and the challenges they face:

Manufacturing:

• Subcontracting Components: A manufacturing company outsources the production of certain components to reduce costs or access specialized expertise.
• Raw Material Suppliers: Ensuring the quality and consistency of raw materials from external suppliers is crucial for product quality.

IT Services:

• Software Development: Outsourcing software development to third-party vendors to meet project deadlines or access specific skill sets.
• Cloud Service Providers: Relying on cloud-based services for data storage, computing power, and other IT infrastructure.

Healthcare:

• Medical Device Suppliers: Hospitals and clinics depend on external suppliers for medical equipment and supplies.
• Laboratory Services: Outsourcing specific medical tests to external laboratories for efficiency and specialized expertise.

Challenges and Best Practices

• Supplier Selection: Identifying reliable and competent suppliers can be challenging. Implementing a robust supplier evaluation and selection process is essential.
• Communication and Collaboration: Effective communication and collaboration with external providers are crucial for ensuring alignment with quality requirements.
• Risk Management: Assessing and mitigating risks associated with external providers is vital. This includes supply chain disruptions, quality issues, and security breaches.
• Performance Monitoring: Continuously monitoring and evaluating supplier performance is essential for maintaining quality standards. Key performance indicators (KPIs) should be established to measure supplier performance.
• Corrective Action: Developing a process for addressing supplier non-conformances and implementing corrective actions is crucial for preventing recurrence.

Practical Tips

• Supplier Audits: Conduct regular audits of external providers to assess their quality management system and compliance with requirements.
• Supplier Development: Collaborate with suppliers to improve their capabilities and performance.
• Risk-Based Approach: Focus on managing critical suppliers and implementing risk mitigation measures.
• Supplier Relationship Management: Build strong relationships with key suppliers to foster trust and cooperation.
• Continuous Improvement: Regularly review and update the supplier management process to adapt to changing business needs.

By effectively managing external providers, organizations can enhance product and service quality, reduce risks, and improve overall business performance.