Although the Standard is copyrighted, and we cannot provide a copy here, we have summarized the major requirements of the standard. For critical decision making, be sure to refer to the actual Standard, which can be ordered from ASQ on-online.
Product realization is the term used to describe the work that the organization goes through to develop, manufacture, and deliver the finished goods or services. An effective Quality Management System (QMS) includes a comprehensive approach to getting from the product concept to the finished product. This approach, sometimes called a quality plan, includes the following:
The Standard requires the organization to determine product requirements. These requirements can come from the customer, may be mandated by laws or regulations, and include generally accepted standards within your industry or market. Requirements are established by standard contracts or oral agreements that the sales department uses in discussions with customers, and other sources.
After gathering preliminary product requirements, these requirements need to be reviewed to be sure that the customer understands them and that the organization is meeting these requirements. This review must ensure:
Routine orders for items described in a catalog of products are considered reviewed when the relevant product information is reviewed.
Put in place effective customer communications channels, to allow dialogue regarding:
To effectively plan the design and development process, the organization must:
Determine the product requirements, including:
The output of design and development must include sufficient information to verify that design output meets design input requirements. In addition, it must:
Review the design and development work products to:
Include representatives from each function concerned with the design and development stage being reviewed. Keep records of the reviews.
Verify, according to your plan, that the design output meets design input requirements. Record the results of these verification activities.
Validate the operation of the resulting product under actual operating conditions. If the product has multiple uses, validate operation for each intended use. The methods for validation defined in the design output should be followed. Whenever possible, the validation of a product or service should be performed prior to delivery to the customer. Record the results of these validation activities.
Identify, document, review, and approve all design changes before carrying them out. Evaluate the impact of the changes on the present design of the product. Keep records of the review.
The organization needs to ensure that purchased products and services meet purchasing requirements. The purchasing group must establish criteria for how they evaluate and choose suppliers. These criteria must be based on the suppliers’ ability to provide products and services that meet order specifications, especially product and service quality requirements. The extent of the controls depend on the importance of the purchased goods in the finished product. Finally, records must be kept showing how purchased products and services were evaluated.
Clearly describe on purchase orders the product or service being ordered. Consider including the following specifications:
Review and approve purchasing requirements before sending them out.
Carry out a plan for verifying that purchased services and materials are adequate, i.e. meet purchase specifications.
Plan production, installation, and service processes and provide an environment where work can proceed in an orderly fashion. These controlled conditions may include:
Process validation demonstrates that operation of the processes achieves the planned results. When it is not possible to verify the finished good or service through monitoring or measurement the QMS must require validation. Validation is particularly important where deficiencies are not identified until the product is in use, or the service is delivered. When validation is required, the QMS must define the criteria for the following:
Where appropriate, establish procedures to identify a product and determine what specifications pertain to it as it moves through manufacturing, delivery, and installation. Record the inspection and measurement status of the product. Individual products or batches of products must have unique serial identification recorded if assuring product product quality requires this.
Special care must be taken when a customer provides their property for use or incorporation into the product. Identify, verify, and protect customer property provided and maintain records of lost, damaged or unsuitable customer property. This may include intellectual property.
The standard requires the organization to preserve the product, including identification, handling, storage, packaging, protection, and delivery of parts and products throughout all processes.
Any measurement worth taking is worth taking correctly. The standard requires the organization to identify the inspection, test and measurements taken, their required accuracy, and the equipment used to make the measurements. Procedures must describe how measurements are carried out.
Measuring equipment must be carefully cared for, including:
Measurements taken with equipment later found to be inaccurate must be assessed and corrected.
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