BS ISO 31120-1-2022 pdf free download.Road vehicles — Injection water Part 1: Quality requirements
6.3 Testing The quality of each production batch of IW shall be verified prior to shipment according to the specification defined in this document. The results shall be noted in writing and shall be kept on file at the production sites.
NOTE In case of dispute, qualified laboratories for verification are laboratories certified to ISO/IEC 17025 or equivalent national standard.
6.4 Procedures for product release and handling of non-conforming product Production batches of IW may be released for the intended use if the results of testing fully conform to the specifications defined in this document or if the manufacturing process verification data support that the product is in conformance with the specifications of this document.
Should there be any parameter deviating from specification or any doubt about the quality of the product, due to, for example, containers without labels, coloured or cloudy product, uncharacteristic smell or a shelf life being exceeded, the IW in the container shall be withheld and stored separately and labelled accordingly.
Further investigations should then be carried out.
To re-enter the distribution chain, the product quality shall be re-checked and be verified that the quality standards defined in this document are fulfilled. If the results of an analysis reveal that the IW from the same production batch has the same fault, the shipments concerned shall be recalled.
To minimize the risk of overlooking an unidentified contaminant, such returned product, when judged not in compliance with the specification, shall be downgraded and shall no longer be designated as IW.
For closed containers with an expired shelf life, it is sufficient to test the quality of the IW in the containers according to this document for a decision about further use. Closed containers with a content of up to about 5 l (small containers) should be either discarded if the shelf life is expired, or retested to decide whether the IW in the containers may be used further or used in other applications.
For small containers of IW having an expired shelf life, re-testing of only one container is sufficient, if all such containers have been produced from the same production batch and have been stored under identical conditions.
6.5 Quality monitoring
6.5.1 General For each production batch of IW delivered, the manufacturer should supply a quality certificate (for example, a certificate of compliance with the order or test report). Methods to determine characteristic product parameters comprise tests, by which IW can be clearly identified and possible contaminations discovered. A typical but not exhaustive list of properties to be determined for the sake of product identification is, for example, electrical conductivity, pH, total organic carbon (TOC).
A minimum contamination test should consist of a check of the product for colour, suspended particles and odour.
A minimum contamination test should be performed every time IW in bulk is transferred from one bulk container to another bulk container.
6.5.2 Audits All parties of the distribution chain have the responsibility to audit their portion of the chain for assuring the quality of the IW. Actions should be taken by the responsible parties to resolve any problems identified.
6.5.3 Documentation Procedures and records of the distribution chain of IW concerning production, product delivery, loading, storage, sampling, testing, product release, handling, as well as audits, shall be documented, for example, according to the guidelines of quality standard ISO 9001. Quality documents should be kept on file for five years.
7 Procedures for handling of containers and equipment
7.1 General
— All handling equipment for packaged shipment and for bulk operation should be dedicated or thoroughly cleaned, proven clean and marked ready for the use with IW.
— To avoid any contamination, dedicated or thoroughly cleaned and proven clean containers should be used.
— Temperature control means may be necessary to maintain the IW within the recommended temperature range as indicated in 5.2.
— The components of the filling and emptying equipment should be emptied, cleaned, and closed off after use in order to prevent contamination of IW from the surrounding. Hoses, especially, should be dedicated to IW and should be closed after every use and handled and stored in a controlled manner.
7.2 Single use non-bulk containers
— Every container shall have an identification label or stamp so that its content can be traced back to the original production batch of IW of the supplier.
— To be able to recognize foreign matter such as dust, insects or any other insoluble matter, the inside of the containers should be checked visually prior to filling according to a written procedure. If foreign matter is found inside the containers, proceed according to 7.4.
— During the filling of a series of small containers with IW, a one litre sample should be taken from the first container filled. If the containers are smaller than one litre in size, the sample taken should be the first filled container. The sample should be kept as a retention sample.BS ISO 31120-1 pdf download.