The Structure of ISO 9001:2008
5.7 SECTION 7 – PRODUCT REALISATION
5.7.5 Section 7.5 Production and Service Provision
Section 7.5
Production and service provision
The organisation shall have procedures for the control of:
Production and service operations;
Validation of processes;
Identification and traceability;
Customer property;
Preservation of product.
Proof The availability of a process to cover all production and service operations.
Likely documentation Documented:
Processes;
QPs;
WIs.
A documented process needs to be agreed upon and implemented by the organisation to cover all production and service operations.
5.7.5.1 Section 7.5.1 Control of Production and Service Provision
Section 7.5.1 Control of production and service provision
The organisation shall have the following available:
Information concerning product characteristics;
Appropriate WIs;
Suitable production equipment;
Measuring and monitoring devices and facilities;
Processes to cover the release, delivery and post-delivery activities.
Proof The availability of all relevant information concerning control of production and service operations.
Likely documentation Procedures;
Project plans;
Resources.
The organisation should identify the requirements for product realisation and ensure that it has:
The ability to comply with contractual requirements;
The ability to train and have available competent people;
A viable system for communication;
A process for problem prevention.
5.7.5.2 Section 7.5.2 Validation of Processes for Production and Service Provisions
Section 7.5.2 Validation of processes for production and service provisions
The organisation shall define validation arrangements for:
Review and approval of processes;
Approval of equipment;
Qualification of personnel;
Use of defined methodologies and procedures;
Requirements for records;
Revalidation.
Proof How an organisation identifies processes which cannot be verified by subsequent monitoring/testing/inspection (including the validation of these processes to demonstrate their effectiveness).
Likely documentation Documented:
Processes;
QPs;
WIs.
Where the resulting output cannot be verified by subsequent measurement or monitoring (and where deficiencies may become apparent only after the product is in use or the service has been delivered), the organisation needs to validate any production and/or service processes to demonstrate the ability of the processes to achieve their planned results.
The organisation should have procedures available to ensure that these processes are completed under controlled conditions especially with respect to special processes and to define work to be carried out where no previous procedure exists.
Note: Design verification is a process whose purpose is to examine design outputs and to use objective evidence to confirm that outputs meet design input requirements. Your purpose here is to see whether your design outputs meet your organisation’s design goals. Design validation is a process whose purpose is to examine products and to use objective evidence to confirm that these products meet customer needs and expectations. Your purpose here is to see whether your product does what your customer or user wants it to do under real-world conditions.
5.7.5.3 Section 7.5.3 Identification and Traceability
Section 7.5.3 Identification and traceability
The organisation shall have procedures available for:
Identification of product;
Product status;
Traceability.
Proof How the status of a product is identified during all stages of its production/delivery.
Likely documentation Documented:
Processes;
QPs;
WIs.
ISO 9001:2008 recommends that organisations maintain documented procedures for identifying products (hardware, software, documents and/or data) throughout all stages of production, delivery, receipt and installation. This process should be documented and reviewed for its continued applicability on a regular basis.
If required, organisations can also establish a system for identifying indi-vidual products or batches.
All received goods should be inspected, their status defined and stored until required for use. Non-conforming items should be placed in a reject area or marked as ‘reject for review’. The status of work in progress should be clearly indicated by markings or associated documentation recording the inspections undertaken and their acceptability.
Note: In some industry sectors, configuration management is a means by which identification and traceability are maintained.
5.7.5.4 Section 7.5.4 Customer Property
Section 7.5.4 Customer property
The organisation shall:
Retain records of all customer provided material;
Protect and maintain all customer provided property.
Proof How an organisation looks after a property that has been provided by a customer.
Likely documentation A documented procedure for the control of customer property.
Customer-supplied products are goods which have been provided by the customer (or his agent), normally free of charge, for incorporation into the product. The existence of ‘free issue’ products will only be relevant to certain organisations. However, it should be remembered that items returned to the organisation for repair or rectification are also within this category.
Goods received from customers need to be visually inspected at the receipt stage and any undeclared non-conformance immediately reported to the customer.
The organisation should ensure that all property belonging to the customer (including its intellectual property rights) is protected and that care is taken to ensure that it is well maintained, used in accordance with the supplier’s instructions and safeguarded at all times.
Should the items become lost, damaged or unserviceable, whilst in the organisation’s control, the problem should be recorded and the customer advised.
5.7.5.4.1 Purchaser-Supplied Product
In some circumstances material, subassemblies or components may have been supplied to the organisation by the purchaser as part of the contract. In these cases it is important that the organisation has a goods-inward inspection process to assure themselves that the item they are receiving is the correct one, has not been damaged in transit and is suitable for its purpose.
Note: Customer property can include ‘intellectual property’!
5.7.5.5 Section 7.5.5 Preservation of Product
Section 7.4.3
Preservation of product
The organisation shall have procedures available for identifying, handling, packaging, storing and protecting products during internal processing and delivery to their intended destination.
Proof How an organisation looks after its own products.
Likely documentation Product approval procedures;
Procedures which ensure the safety and protection of products.
5.7.5.5.1 Part Numbers and Labels
A manufacturer’s/supplier’s part number or description label should identify any material or equipment that cannot be obviously identified. This identifi-cation can be on the packaging or on the item itself and should remain in
place for as long as possible, provided it does not hamper effective use of the item. If items have a serial number, then this number should also be recorded.
5.7.5.5.2 Product Protection
All materials and goods that are received, whether they are the property of the organisation or others, should, as far as practicable, be protected and their quality preserved until such time as they are transferred to a customer, disposed of to a third party or utilised. The overall objective should be to prevent deterioration and damage whilst in storage or in the process of transportation, installation, commissioning and/or maintenance. Written instructions and procedures for the handling, identification and storage of documentation, materials, components, parts, subassemblies and completed items will have to be established and made available. These instructions must contain details of quarantine areas or bonded stores, how they should be used, together with methods of cleaning, preserving and packaging.
5.7.5.5.3 Documented Procedures
As previously mentioned, ISO 9001:2008 recommends organisations to maintain documented procedures for identifying products (e.g. hardware, software, documents and/or data) throughout all stages of production, delivery, receipt and installation. If required, organisations can also establish a system for identifying individual products or batches and consider the need for any special requirements (i.e. associated with software, electronic media, hazardous materials, specialist personnel and products or materials) arising from the nature of the product which are unique or irreplaceable.
In some cases (e.g. toxic contamination), in order to prevent damage and deterioration of the product (and harm to the product user!), it might even be necessary to refer to another document, regulation or standard to ensure that the items are correctly handled, stored and delivered.
5.7.5.5.4 Storage
All QMS standards emphasise the importance of having satisfactory storage facilities and stipulate that these must be available for all materials, consum-ables, components, subassemblies or completed articles. In a similar manner, the standards specify that materials should always be properly stored, segre-gated, handled and protected during production so as to maintain their suitability.
The supplier will thus have to provide secure storage areas or stock rooms so that the materials can be isolated and protected (e.g. from harmful environ-ments) pending use or shipment. Storage areas will have to be protected and kept tidy and the supplier must ensure that material only leaves the storage areas when it has been properly authorised.
Procedures for rotation of stock will need to be established and special consideration should always be given to items with limited shelf-life and items that might require special protection during transit or storage. This is usually referred to as deterioration control. Where corrosive or toxic materials are stored in quantity, these items must be kept in a separate storage area.
Note: Although the above explanation primarily concerns a manufactured item, storage facilities, nevertheless, still have to be considered for documents and/or software.
5.7.5.5.5 Delivery
The supplier must make arrangements to ensure that the quality of the product is protected following final inspection and test. Where contractually specified, this protection can even be extended to include delivery to the final destination.
Some of the factors that should be considered by suppliers when delivering their product to the purchaser are:
The nature of the material;
The type(s) of transport to be used;
Environmental conditions during transit;
Time in transit;
Handling methods en route;
Storage en route and at the destination.