The purpose of this section is to give an overview of the policies developed by the Animal Resources Centre to achieve an effective system designed to ensure consistency in the quality of our products, and a culture of continuous improvement. The applicable standard for the Quality Management System is ISO9001:2008 (http://www.iso.org/iso/home.html).
There is a commitment to continually improving the service and products we provide to our customers by having well defined procedures which are used and understood by all staff, and having useful measurements recorded to ensure quality of performance is at least maintained.
- Our major business processes are:
- Maintenance of inbred strains of mice and rats
- Production of outbred and inbred strains of mice and rats for sale
- Importation of rodents
- Production of targeted mutant and transgenic mice
- Cryopreservation of rodents
Description of the Quality System
The Quality System is documented in three levels, a Quality Manual
that documents the Animal Resources Centre’ s policies, Standard Operating Procedures
that document how policies are implemented and Work Instructions
that describe in detail how each task is completed.
All personnel are responsible to ensure the system is documented. Each area manager ensures that there are adequate Work Instructions in their area to enable high consistency of output consistant with the SOP’s. They also ensure that people under their control follow defined processes and are encouraged and empowered to suggest and implement improvements to the system. These improvements are then formally documented.
When customers place orders their requirements are clarified by the person who has taken the order before the information is put into the computerised order, despatching and invoicing system.
A major aim of our quality system is to develop close, long term working relationships with our suppliers to ensure mutual quality improvements, and lower total costs. Procedures for purchasing goods and services ensure that we can fulfil our customers’ requirements in terms of quality of our products, timeliness of delivery and cost.
Identification and traceability
The materials that are used to produce animals that can be identified and traced are diet, some forms of bedding and strains of animals imported to establish new colonies. Because of the method of laboratory animal production there is no batch numbering system of animals produced.
Only one supplier of feed is used and incoming feed is identified. The date received and the date(s) that the batch is sterilised and enters the barrier unit is recorded. Imported animals are always quarantined and records are kept of breeding and movement of these animals.
Customer orders are checked immediately prior to delivery against the written order. The Area Production Manager ensures that the order as sent out meets the customers’ requirements and that the delivery details are correct.
Operations that contribute to ensuring high quality performance are carefully planned and documented. Procedures and checks are put in place to control the process for consistent performance. Production equipment such as autoclaves, air-conditioning systems, boilers and watering systems are maintained to ensure that they are capable of performing the job intended
Computerised environmental monitoring control, work procedures and regular housekeeping ensures that there is a suitable environment for the production of specified pathogen free animals and working environment for staff.
The processes of inbred strain maintenance, outbred and inbred strain production, despatching, quality control, stores supply and processing and quality control are fully documented and audited regularly.
Under normal circumstances there are no in process monitoring control procedures. All tests performed to ensure that animals are specified pathogen free and genetically uniform occur at accepted regular intervals on animals in the facility. These tests do not relate to individual animals but to production units or strains of animals. The results are always retrospective in that they show what has happened at some point between the next to last and the last test but they do not show when the change occurred.
Inspection and testing
Inspections and tests are performed to ensure that animals are healthy, specific pathogen free and genetically uniform and the environment remains sterile.
Products received for use in the production of animals, namely food and bedding, are checked to ensure they are the correct product and they are free from damage. Any products found not to conform are sent back to the supplier to prevent them being used in the process. Feed is examined at regular intervals to ensure nutrient content is adequate.
To ensure that the correct type of animal is supplied, all cages are identified throughout the whole production process. Animals are visually inspected daily by trained personnel for general healthiness and are inspected by handling at weaning, sex-checking and dispatch.
Weaning numbers are analysed to determine whether the production rate meets expectations.
Inspection, measuring and test equipment
Measurements relevant to process control are the temperature of air supplied to rooms, pH of water supplied to animals, the weight of animals supplied to customers and the temperature of autoclaves used to sterilise materials and equipment. Measurement equipment is calibrated against standards supplied by the manufacturer or standard weights and temperature traceable to Australian and International standards.
Inspection and test status
All animals are identified by Strain Selection cards and/or cage labels. The labelling system is used to identify the status of the product during the production and dispatch processes to ensure that the product supplied conforms to the customers’ requirements.
Control of non-conforming product
Non-conformance of laboratory animals is manifest in a number of ways. The simplest manifestation ie. a minor non-conformance, is an abnormality in development that becomes visible during the rearing period, eg. small or absent eyes in C57BL/6 mice. Minor non-conformances may also be manifested as non-specific poor health, diseases that occur as a result of ageing such as cancer, and wounds from fighting. In these cases animals are euthanised before dispatch.
A major non-conformance occurs when animals either become genetically contaminated and are therefore no longer “genetically uniform”, or when animals become infected with an agent that destroys their “specified pathogen free” status. The handling of non-conformances such as these is complicated because the tests that detect the non-conformances are retrospective and it is highly likely that animals will have been supplied in good faith without knowing of the non-conformance. Once a major non-conformance is found, a review is made by the CEO, Director Operations and Manager Veterinary Services and Quality Control to determine what action should be taken.
Customer complaints are handled by the CEO and /or the Director Operations on a case by case basis and directly with the customer. Records of the complaint and the action taken are filed in a “Complaints” file and reviewed at Management Review meetings.
Packing and delivery
Environmental conditions conducive to the welfare of animals is ensured during road and air transport. Animals are transported in containers that International Air Transport Association (IATA) requirements. Performance is measured by production data
, examining genetic
status (quality control measures), the attitude of our customers to us
(by customer satisfaction surveys and sales).