Hey everyone! Welcome back to our blog. Today, we’re diving into an essential aspect of ISO 9001:2015—Subclause 8.5.1, which focuses on the control of production and service provision. Let’s break it down and understand why this is crucial for maintaining quality and compliance in your organization.
What is the Essence of Control of Production?
At its core, this section emphasizes process control. While other parts of ISO 9001:2015 discuss processes more generally, subclause 8.5.1 zooms in on production. You must ensure that all processes producing your goods and services are effectively controlled to maintain quality.
Control can mean different things, and ISO 9001 provides guidelines to help you determine which controls are necessary for your specific processes. It’s up to you to implement the applicable controls to maintain compliance and quality.
Availability of Product and Service Specifications
One of the primary requirements here is ensuring the availability of product and service specifications. Your products and services need to meet both internal and external requirements. Here’s how you can manage this:
Document all applicable requirements, including those mandated by customers, legally mandated requirements, and corporate standards.
Common documentation includes:
Product Specifications
Drawings and Blueprints
Work Orders
Schedules
Contracts
Job Folders
Production Tickets
Performance Properties of Products and Services
Next, focus on the performance properties of your products and services. Define what your products should achieve and ensure that these outcomes are documented within your specifications. This ties into clause 8.6, which pertains to the release of products and services—where you verify that your offerings meet all relevant requirements.
Verification Equipment: Availability and Use
Planning in clause 8.1 dictates the need for verification equipment. If you've identified necessary monitoring and measuring devices, ensure they are available and operational.
Implementing Monitoring and Measurement
Once you've committed to monitoring, you must follow through. This involves maintaining records to prove that your processes, products, and services meet set criteria. Remember, determining what equipment and environment are suitable occurs during planning in clause 8.1. For more details, refer to subclauses 7.1.3 and 7.1.4.
Effective Infrastructure and Environment
An effective infrastructure and environment are key. You need the right tools and conditions to produce quality products or services. If your current setup is inadequate, take necessary actions, often through a maintenance program, whether in-house or subcontracted.
Competent Personnel: Selection and Training
ISO 9001:2015 requires you to define the necessary competence for personnel involved in production processes. This reinforces the need for ongoing training and performance assessments to ensure quality.
Process Validation and Human Error Reduction
In rare cases where outcomes cannot be verified before use, ISO provides three options:
Validation: Proving processes can produce expected outcomes reliably.
Periodic Revalidation: Regular reassessment of processes to maintain quality standards.
Focus on Outcomes: Ensuring processes consistently achieve intended results.
Additionally, aim to reduce human error. Implement strategies to error-proof processes, a principle central to lean manufacturing.
Practical Steps to Remove Human Error
Assign Locations for Tools: Ensure tools and supplies have designated spots.
Use Forms and Checklists: Standardize tasks to prevent neglecting details.
Parcel Specific Quantities: Organize items in manageable, clear quantities.
Emergency Stops: Implement safety measures to prevent accidents.
Document Control: Keep only current information accessible to reduce errors.
Use Templates: Provide clear guidelines for tasks to prevent confusion.
Examining Your Processes
Encourage your team to examine processes and suggest improvements. By engaging with employees, you can identify numerous opportunities for error-proofing.
Release, Delivery, and Post-Delivery Activities
Finally, establish control over release, delivery, and post-delivery activities. This ensures that customer requirements are met throughout the entire process, maintaining satisfaction and compliance.
Real Survey Questions to Consider
To better understand your organization's practices, reflect on these questions:
How does the organization maintain control over production processes?
What methods are used for effective planning and implementation?
How is personnel competence ensured?
Are there procedures in place for monitoring process performance?
How are changes managed to prevent negative impacts on quality?
Conclusion
In summary, controlling your production processes is vital to ensuring your products and services meet all necessary requirements. If you found this article helpful, please share it with your peers and stay tuned for more insights!
By focusing on these key areas, organizations can effectively manage their production and service provision, ensuring compliance with ISO 9001:2015 and maintaining high-quality standards. If you have any questions or thoughts, feel free to leave a comment below!
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