ISO9

Product realization deals with the steps and processes that your organization goes through to deliver your finished goods or services. An effective Quality Management System (QMS) needs to develop a comprehensive approach to getting from the starting point to the finish line. This approach must be planned out and the important steps and stages must be written down.

The ISO 9000 Standard requires you to assess your organization’s product or process requirements. You need to consider all manner of requirements. These requirements could come from the customer, could be mandated by law or could be generally accepted standards within your industry. How do you determine what customer requirements are? The first place to start is to check any standard contracts or oral agreements that your sales department uses. Any modifications to these standard agreements should be considered as well.

After you determine what the product or service requirements are, you need to review to make sure that you are meeting these requirements. The logical sequence to perform this review would be to make sure:
1. The requirements are defined
2. The organization has the ability to meet the requirements
3. Process or production changes are reviewed and documented

An effective QMS will address communications with an organization’s customers. You should make sure that customers have readily available information regarding your product offerings, the status of contract negotiations or the handling of orders, and how they can provide feedback to you or express any complaints.

In order to effectively plan the design and development process, you need to follow three steps:
1. Clearly define the stages involved in the process
2. Identify the responsible parties for each of those stages
3. Review that these responsibilities have been carried out effectively

In order to properly design and develop an effective product or service you must consider all relevant factors. To some degree, you should address the marketability of the product or service, since you need to consider the customer. However, the critical areas to consider in a QMS are performance, legal and regulatory, and any other requirements, such as industry, or organization standard practices.

Information included in the output of design and development should include sufficient information to show that the requirements specified in the inputs document are being met by the product as designed, and how potential risks have been mitigated. It should also include information on how the product is to be built, including such things as specifications, purchasing, testing, the records and documentation required during manufacturing, training requirements, user and customer information, and any other information needed by your organization to build and use the product so that it meets the requirements. This process should be documented and approved.

After you determine what the design and development requirements are, you need to review to make sure that you are meeting these requirements. Employees who have been involved in the process should be used to perform this review and determine that the design and development processes are in fact meeting the requirements, problems are identified and solutions are proposed. You need to retain records of design and development review.

Once you have planned and reviewed the design and development process, you need to test, or verify, that the final output did in fact meet the requirements. There are a variety of methods that you could use to perform these tests. Your particular situation will dictate the best method to use. You must maintain the records of the test results, and any follow up actions taken.

After the design outputs have been verified, validation is performed under actual operating conditions. If the product has multiple uses, each use may be validated separately. The methods for validation defined in the design output should be followed. Whenever possible, the validation of a new product or service should be performed prior to delivery to the customer.

Initial designs are often changed to accommodate custom orders, to try to improve performance, to accommodate a changing input component, or for some other valid reason. The standard requires you to identify and document these engineering change Requests. You also need to analyze the changes prior to implementation and consider what the total impact of the changes may be. You will need to maintain records of these analyses, and any follow up actions taken.

You will need to have a controlled process for dealing with your suppliers. Your purchasing group will need to establish criteria for how they evaluate and choose your vendors. These criteria should be based on the suppliers’ ability to meet your order specifications. You will need to have procedures for making sure that purchased product meets your specifications. Finally, you must maintain records that show how the purchased product was evaluated, and what you did when you discovered problems.

Purchasing information describes the product to be purchased. It can be included on contracts, purchase orders or other documents. Your QMS should make sure that the purchasing information meets the requirements, and addresses when and what type of approval is required. You should also describe any particular conditions for the purchasing information to comply with specific requirements in your QMS.

You will need to put in place inspection procedures, when and where appropriate, for purchased product. The most explicit purchase orders may still not be complied with. Since you need to determine that the products and services ordered meet your predetermined specifications, you will need to test to some degree to ensure that these specifications were in fact met. You will also need to document the results of these tests.

Planning and production activities should take place in a controlled environment. A controlled environment means that your employees have use of, and access to, instructions on how to do their jobs and all of the equipment necessary to assemble and test the product or deliver the service. This controlled environment should exist from the time product requirements are developed to the time the product or service is delivered.

Validation demonstrates that proper application of the processes can achieve the planned results. When it is not possible to verify the finished good or service through monitoring or measurement your QMS should call for validation. Validation is particularly important where deficiencies are not identified until the product is in use, or the service is delivered. When validation is appropriate, your QMS will need to define the criteria for the following areas involved in the process:

Approval of validation procedures and equipment

Qualification of personnel

Backup plan if validation fails

When a product is being tested or measured, at any point in the production cycle, it must be identified. This identification should provide for traceability or the ability to follow the product throughout the production process, both physically and through documentation.

Special care must be taken when a customer provides you with their property for use or incorporation into the product. You will need to identify and protect customer property provided and maintain records of lost, damaged or unsuitable customer property.

The standard requires your organization to maintain procedures for the handling, storage, packaging, preservation, and delivery of parts and products throughout all processes.

Monitoring and test equipment can be central to any effective QMS. Because of this fact, the standard puts an emphasis on carefully managing and maintaining these devises. Appropriate QMS procedures are necessary to determine that appropriate monitoring and measuring methods and equipment are used to achieve planned results. Processes need to be established to ensure that monitoring and measuring is consistently carried out according to acceptable standards. Measuring or monitoring equipment should be protected from damage or unplanned adjustment. Records of monitoring and measuring results must be maintained and assessed. If the results indicate that equipment is not properly calibrated, any remedial actions taken should be documented.