8.1 Operational Planning and Control in ISO 9001:2015

Operational planning is about controlling the design and development process. The organization must ensure that all related activities take place under controlled conditions. Operational planning and control requirements (ISO 9001:2015) are comparable to the requirements from ISO 9001:2008 Clause 7.1 – Product Realization Planning, but it has been extended to include implementation and control, as well planning.

Your organization needs to plan in advance for how they will manufacture their product or deliver their service. The plans need to take into account the product requirements and any quality objectives that might be appropriate, resources and documents that may be necessary, what type of monitoring and/or inspection activities should be put in place to ensure the product or service will meet the requirements, and what types of records should be kept.

There should be a process for developing work instructions that detail standard practice for performing tasks that comply with all management system requirements, as well as a process for identifying hazards and controlling tasks for all non-routine tasks and ensuring all safety and environmental requirements are met.

You should seek and record evidence that your organization has determined the design and the processes to meet the requirements of your customers and the requirements of your management system. Evidence that the processes, including all inputs, outputs, resources, controls, criteria, and process measurement and performance indicators being planned should be sought. Operational planning includes the following elements:

1. Developing process plans that include clear, concise and detailed work instructions;
2. Defining quality objectives and requirements (tolerances, surface finish, workmanship standards, etc.) for the product or service;
3. Defining how quality objectives and requirements are documented; e.g. drawings, specifications, models, etc., and communicated, e.g. instructions, pre-production samples, operator training, etc.
4. Ensuring that product and service inspection and testing methods and procedures are defined and documented, along with their respective acceptance criteria;
5. Ensuring that each specified inspection, test and monitoring activity is recorded through work orders, tags, tickets, forms, electronic data collection systems, etc.;
6. Undertaking risk analysis studies of key manufacturing processes and ensuring mitigations arising from risk management are incorporated into key product and or process designs;
7. Developing the capabilities, training, qualifications, procedures and work instructions necessary to execute the requirements to ensure product compliance to contract/customer requirements;
8. Developing training and procedures to ensure general workmanship, safety, equipment maintenance and qualification, material handling and environmental standards are maintained in a manner consistent with contract/customer requirements and sound business practices;
9. Designating and maintaining an adequate number of personnel trained and qualified to support both new product development and continuous process improvement;
10. Implementing a production and purchasing control systems capable of managing all phases of manufacturing and service delivery, from scheduling of customer needs, to the delivery of finished goods. The system employed should account for every part entered into the manufacturing process and provide for lot/batch tracking, traceability and integrity of process, including documentation of delays and interruptions;
11. Ensuring suitable production facilities, equipment, inspection and servicing capabilities are available to achieve contract/customer requirements.
12. Ensuring that environmental factors such as lighting, housekeeping, contamination, handling equipment, temperature compensation and process licencing are managed in such a way as to comply with contract/customer and regulatory agency requirements.
13. Controlling conditions such as utilities and supplies including water, compressed air, electricity and chemical products to the extent they affect product quality.

Department Managers must ensure that work practices and instructions are developed as necessary to support the execution of process and production plans, while supervisors at every level must ensure that training is implemented and that qualifications are maintained to support the requirements of process and production plans.

Operational personnel must carry out the process and production plans as per instructions and in the sequence presented to them. When required, they must stop work if they identify any discrepancies in product, planning or instructions to their immediate supervisor, and make input into process improvement or corrective action.