Product realization is the backbone of any quality management system. It encompasses the entire journey from understanding what your customer needs to delivering the finished product or service. ISO 9001:2000 Clause 7 defines product realization as the work that organizations go through to develop, manufacture, and deliver finished goods or services. This clause provides a comprehensive framework that ensures products consistently meet customer requirements and regulatory standards.
Table of Contents
- What is product realization?
- Planning of product realization
- Understanding and meeting customer requirements
- Determination of requirements
- Review of requirements
- Customer communication
- Design and development processes
- Planning and inputs
- Design verification and validation
- Design reviews and changes
- Purchasing processes
- Production and service provision
- Control of production
- Validation of processes
- Identification and traceability
- Customer property
- Preservation of product
- Control of monitoring and measuring devices
What is product realization?
Product realization describes the complete process of bringing a product from concept to market. An effective Quality Management System requires a comprehensive approach to getting from the product concept to the finished product. This approach, sometimes called a quality plan, includes product requirements and quality objectives, creation of the necessary processes and documents, required verification and monitoring activities, and the records to be maintained throughout the process.
Planning of product realization
Planning forms the foundation of successful product realization. Organizations must determine what needs to be done at each stage, what resources are required, and how success will be measured. This planning includes establishing product requirements and quality objectives, creating the processes, documents, and resources needed for product realization, defining required verification, monitoring, inspection, and test activities, and identifying the records to be kept.
The planning phase ensures that everyone understands their role and that the organization has allocated adequate resources before production begins. This proactive approach reduces errors and prevents costly rework later in the process.
Understanding and meeting customer requirements
At the heart of ISO 9001:2000 lies the principle of customer focus. Organizations must accurately determine what customers need and expect from their products or services.
Determination of requirements
Requirements can come from multiple sources. They may be specified directly by the customer, mandated by laws or regulations, or include generally accepted standards within your industry or market. Organizations establish requirements through standard contracts, oral agreements that the sales department uses in discussions with customers, and other sources. This process ensures that all expectations are clearly understood from the outset.
Review of requirements
After gathering preliminary product requirements, these requirements need to be reviewed to ensure that the customer understands them and that the organization can meet them. This review must confirm that the requirements are known and understood, any changes from the original contract or discussions are understood, and the organization has the ability to meet the requirements. Records must be kept of this review process.
Customer communication
Effective communication channels must be established to allow dialogue regarding product information, questions about contracts, order handling, and changes, as well as receiving customer feedback, including complaints. Clear communication prevents misunderstandings and builds stronger customer relationships.
Design and development processes
For organizations that design their own products or services, the design and development process requires careful control and documentation.
Planning and inputs
Design and development planning requires clearly defining the stages involved in the process, identifying how reviews and verification will take place, describing clear responsibility and authority for the people doing this work, and ensuring design information flows effectively among various groups. Organizations must determine product requirements including what it does and how well it must perform, legal and regulatory requirements, pertinent information from similar designs, and other pertinent requirements.
Design verification and validation
Verification and validation are two distinctly different steps in the design process. Verification is a theoretical exercise designed to make sure that no requirements are missed in the design. It involves comparing design outputs to design inputs to ensure each requirement is accounted for in the documentation.
Validation is a practical exercise that ensures the product, as built, will function to meet the requirements. This step involves building a version of the product-whether an engineering model, prototype, or first production unit-and fully testing it to make sure that the product, as designed, will meet all necessary requirements defined in the design inputs.
Design reviews and changes
Organizations must review design and development work products to determine if the design meets input requirements, identify any problems with the design, and propose solutions to identified design problems. All design changes must be identified, documented, reviewed, and approved before being carried out, with evaluation of the impact on the present design of the product.
Purchasing processes
The quality of purchased products and services directly impacts the quality of your final product. Organizations must establish criteria for evaluating and choosing suppliers based on their ability to provide products and services that meet order specifications, especially product and service quality requirements. The extent of controls depends on the importance of the purchased goods in the finished product.
Purchase orders must clearly describe the product or service being ordered, including how products, procedures, processes, and equipment are approved for purchase, required competencies for contracted personnel, and requirements for the supplier’s quality management system. Organizations must also carry out a plan for verifying that purchased services and materials meet purchase specifications.
Production and service provision
Control of production
Organizations must plan production, installation, and service processes and provide an environment where work can proceed in an orderly fashion. These controlled conditions include information regarding product specifications, written instructions for carrying out the work, suitable equipment, adequate tools for monitoring and measuring process and product characteristics, and criteria for product release.
Validation of processes
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.
Identification and traceability
Organizations must use suitable means to identify outputs when necessary to ensure the conformity of products and services. This includes identifying the status of outputs with respect to monitoring and measurement requirements throughout production and service provision.
Where appropriate, organizations must establish procedures to identify a product and determine what specifications pertain to it as it moves through manufacturing, delivery, and installation. The inspection and measurement status of the product must be recorded. Individual products or batches of products must have unique serial identification recorded if assuring product quality requires this level of traceability.
Customer property
Special care must be taken when a customer provides their property for use or incorporation into the product. Organizations must identify, verify, and protect customer property provided and maintain records of lost, damaged, or unsuitable customer property. This may include intellectual property such as designs, specifications, or confidential information.
Preservation of product
The standard requires organizations to preserve the product, including identification, handling, storage, packaging, protection, and delivery of parts and products throughout all processes. Proper preservation ensures that products maintain their quality characteristics from production through delivery to the customer.
Control of monitoring and measuring devices
Any measurement worth taking is worth taking correctly. Organizations must identify the inspection, test, and measurements taken, their required accuracy, and the equipment used to make the measurements. Measuring equipment must be carefully cared for, including timely calibration to national standards, identification with a calibration label, preventing adjustments that would invalidate the calibration, and preserving the equipment accuracy during handling, storage, and use.
What do you think? How might implementing these product realization processes improve quality and customer satisfaction in your organization? Which aspect of Clause 7 do you find most challenging to implement?
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