Requirements

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7.0 PRODUCT REALISATION

 

Product Realisation, referring to the ISO 9001:2000 Process Model, is the requirement that covers:

• understanding and defining customer needs to
• providing the product or service to the customer

So it will address itself to all those departments in your company that form part of its supply chain. Namely:

• Marketing
• Sales/order processing
• Planning
• Research & Development/Design
• Procurement
• Production/Operations/ Manufacturing
• Installation
• Distribution
• Stores

It is the only requirement within this standard where permissible exclusions are allowed. That is, it is possible that some of the requirements do not apply to your company. For example Research and Development would not apply if you had no design department and you did not do product / service development.

 

7.1 Planning of Product Realisation

This requirement relates to your planning of the realisation process to ensure that all processes from under standing customer needs to providing the product are identified and properly planned. This could address, depending on the type of business:

• Identification of your product/service that you provide to your customer
• Planning the provision of these product/services, eg the sales/order cycle
• Designing or development of the services
• Procurement of materials and other resources
• Producing or providing the product or service
• Installation and support of the product or service

Understand each phase and document what the planning component consists of.

 

7.2 Customer Related Processors

 

7.2.1 Determination of Requirements Related to the Product

This is where the understanding of what your customers wants from you starts. What is it in particular that they need from you? This should address:

• Product and its characteristics
• Price/Delivery
• Payment agreement
• Any legal constraints
• Support

There is no doubt that misunderstandings or lack of clarity in this phase will cause quality issues later on. So do a good job here and make sure that there is a mutual agreement between yourselves and the customer of what is to be provided.

 

7.2.2 Review of Requirements Related to the Product

This is a double check to ensure that the documented requirements, as supplied by your customers are understood and correct. Ideally somebody other than the original order taker should perform this step. Also it is preferable that all order requirements form your customers are documented in writing. At this order review stage check to ensure that your company has the resources to provide the product or service as specified by the customer. In addition any changes in this order phase check, document and circulat to all persons in your company affected by them, including your customer.

 

7.2.3 Customer Communication

This requirement is aimed at ensuring good communication between yourselves and your customer with regard to:

• product information
• order/enquiry handling and changes
• customer feedback
• Customer complaints

Communication can take many forms, verbal, telephone/fax, email, catalogues, web sites, ordering material, etc.

 

7.3 Design & Development

This requirement is not solely aimed at those traditional design departments. Most companies do some form of design and/or development on their service or product. You may for example design the service uniquely for each customer as is the case for some consulting companies. So think broadly on how you do design and development. The standard looks at this process through 7 distinct requirements:

1. Planning – Identify and plan the various design and development phases
2. Inputs – what are the inputs to this process in terms of requirements or constraints
3. Outputs – specify the design outputs required form the design or development proposed
4. Review – ensure that the process is regularly reviewed and recorded
5. Verification – verify the design to check they comply with the input requirements
6. Validation – bench test, piloting, all constructive types of design validating
7. Changes – if changes are necessary through out and post the design process ensure that it is controlled.

 

7.4 Purchasing

 

7.4.1 Purchasing Process

This requirement is directed at the management and interface with those companies providing goods/services to your company. The goods or services in this case being procured. The objective is to ensure that the requirements you have for these procured goods/services are properly defined and communicated to the supplier. Failure to do so may result in the wrong product/service being delivered. Part of this process relates to selection a competent supplier.

 

7.4.2 Purchasing Information

This relates to your specification or requirement for the purchased goods / services and how is this communicated to the supplier. Requirements can address:

• Pre approval of product
• Personnel qualification/competence
• Relating regulations/specifications
• Conformance to systems standards

These requirements would then be transmitted/communicated via a purchase order or contract or something similar. As well these requirements should be verified by your organisation prior to transmission to the supplier.

 

7.4.3 Verification of Purchased Product

Part of the purchase process is to verify that the goods/services that you procured. This may be as simple as inspecting the item upon receipt, but it could also be done prior to shipment. The verification process may leave it up to the supplier to assure you that final checks/inspections have taken place and provide written proof of this (such as a certificate of conformance).

 

7.5 Production and Service Provision

 

7.5.1 Control of Production and Service Provision

This requirement addresses the process of producing the product or delivering the service and how is it controlled. In the previous release of this standard it spoke about process control, that is the intent here, to control the process to produce conforming product. The way this achieve is described as having in place one or more of the following criteria:

• Adequate specifications for the product/service
• Providing instructions of how to produce the product via, Work Instructions, Standard Operating Procedures, Best Operating Practices, etc.
• Making sure that there is adequate equipment to manufacture the product or deliver the service
• Where necessary provide proper measuring and monitoring devices
• Have in place final checks and inspection prior to delivering the product or service

 

7.5.2 Validation of Processes

This requirement would apply where the product or service produced cannot be tested directly. Instead the process that produces the product must be qualified and verified as being in control and correct. Examples of this are rich in the engineering field when looking at such things as welding which is difficult to properly inspect when completed. Instead the approach is to qualify the welder and the settings they use to do the welding thereby assuring a successful weld process.

 

7.5.3 Identification & Traceability

It is necessary to ensure that your product/services and the components that go into their production are properly identified to prevent accidental mix-ups from occurring. Answering the question how do you know what you are using? Identifications can take the form of labeling, colour coding, marking, etc. Furthermore, when it is a requirement the extent of traceability must be defined. That is it maybe necessary to know where component materials come form and who worked on them. This is to be able to trace them back should failure occur and an analysis is required.

 

7.5.4 Customer Property

This refers to any customer owned property (material, components, equipment, etc) that they have provided to you that you will use in the production/delivery of your product or service. What the requirement seeks to control is how you process and manage this properly, form receipt, storage and installation. Should incidents occur such that this property is lost or damage, communication back to the customer is required. This requirement can be extended to customer documentation provided but only where it has to be returned at the end of the contract.

 

7.5.5 Presentation of Product

This requirement addresses the preservation of product conformity during its use in manufacturing/delivery of the product or services. It looks at formalising processes in respect of: Handling, storage, packaging, preserving and delivery process, where any of them apply to you.

 

7.5.6 Control of Measuring & Monitoring Devices

This relates to the equipment use to verify the product conformance referred to in clause 7.5.1 and 7.5.2 for this equipment are they correct in terms of: - accurate - fit for purpose How often are they checked and are there records of these checks? Is the checking frequency appropriate for what is being measured? In the event of non-conforming equipment how is it handled?