Although other aspects of controls required by ISO 9001 may be critical, none receives as much attention as subclause 7.5.1--”Control of production and service provision.” Almost every organization must develop processes for delivering services or producing products. Subclause 7.5.1 focuses on the key concept that processes must be carried out under controlled conditions. Considerations for achieving controlled conditions are clearly stated, along with the requirements to determine the extent to which production and service operations are planned, established, documented, verified, and validated.

These considerations begin with understanding the specifications for the product that the processes will produce. The organization must determine the production and service processes that should be controlled and the outputs that must be achieved at each stage of processing.

Also, the organization must consider the equipment necessary to meet the product requirements, including their sequence and operating conditions. In some cases new equipment must be designed or procured.

The organization must then decide on the criteria for acceptability of these processes and perform evaluations against these criteria. One approach is to perform capability studies to demonstrate process suitability. Once it has determined suitability, the organization can decide if additional process development is required to meet product specifications.

Preventive action is required by the last subclause of ISO 9001, and some users may be misled into thinking that preventive action is the last thing to think about when implementing a quality management system. Nothing could be further from the truth; it’s in planning product design and production that the preventive-action process is most effective. The first step is to determine what potential nonconformities might occur and to plan controls to prevent their occurrence. Appropriate criteria and controls for the production processes must be determined and implemented to maintain process capability to prevent nonconformities from occurring. Work instructions should be identified and developed along with associated measurement equipment. When determining the extent of documentation needed, the organization should consider the product’s criticality, its employees’ competency, and its own complexity and size. Verification activities should be integrated into the processes to maximize both the efficiency of the verification and confidence in the product. These requirements apply in all cases, whether hardware, computer software, processed materials, or services.

Raw materials, parts, and subassemblies for hardware and processed materials should conform to appropriate specifications before being introduced into processing. Organizations should compare the cost of evaluation at various stages to the potential cost of rework at subsequent stages. In-process materials should be appropriately stored and protected to maintain their suitability. Special consideration should be given to shelf life and the potential for deterioration. Where traceability of material is important to quality, appropriate identification must be maintained throughout processing. Where it is important to quality characteristics, support materials and utilities such as compressed air or chemicals used for processing should be controlled and verified periodically to ensure uniformity of their effect on the process. Where a work environment such as temperature, humidity, and cleanliness is important to product and service quality, appropriate limits should be specified, controlled, and verified.

Creating software code is usually considered part of the design and development process. Mass production of software simply involves replicating the code. Nevertheless, it’s essential to control code replication and subsequent installation and servicing processes. Managing software configuration during these stages is critical.

The task of the service organization is to plan, monitor, and systematically deliver services so that the quality objectives are achieved. For some types of services, there is little or no process equipment to control because the service consists of actions performed by personnel directly for or with the customer. In these cases, the requirements of this subclause apply directly to service personnel and the processes that control their competence.

No matter what your product, proper controls ensure that you can consistently meet your own product-design requirements. Thus, with great design control, production, and service delivery, you’re in an excellent position to satisfy your customers every time.