6. Quality system requirements
6.1. Management responsibility
6.1.1. Quality policy
GVP Guide Entry
GVP-veterinary practices and GVP-veterinarians shall define their quality policy. This policy shall include the quality objectives and the management commitent to its delivery. The quality policy shall be relevant to the type of veterinary services offered. The quality policy shall be documented.
The management of a GVP-veterinary practice and GVP-veterinarians shall ensure that the quality policy is understood and all its requirements implemented by all employees.
6.1.2. Organization
GVP Guide Entry
If more than one person works in the GVP-veterinary practice or when GVP-veterinarians have employees the following will be clearly defined and documented:
- the responsibilities of all staff
- the interrelation of the management duties
- at least the following duties will be assigned and clearly documented:
- quality system manager, with authority to take the necessary actions to prevent the re-occurrence of non-conformities
- veterinary medicines depot manager, with authority to take all necessary action related to the control over the medicines used
- internal auditor
- environment manager, responsible for all matters relating to the environment and waste, with authority to take all necessary actions
- schedules for weekly duties, holiday cover, sickness cover
- a formal decision-taking structure.
An organogram shall clearly demonstrate the interrelation of the different duties.
In single-vet GVP-veterinary practices there shall be documented procedures for sickness and holiday cover and the veterinarian shall be responsible for all functions described above apart from the internal auditor function. A documented procedure shall describe how and by whom the internal audits shall be performed.
6.1.3. Management review
GVP Guide Entry
The management of a GVP-veterinary practice and GVP-veterinarians shall at least yearly formally review the quality system to ensure its continuing effectiveness and suitability.
The management review procedures shall be documented.
Records of these reviews and their outcome shall be kept.
Relevant data to include in the assessment are amongst others:
- epidemiological trends, changes in patient population
- changes in legislation or protocols
- review of complaints
- results of internal audits
6.2. Quality system
GVP Guide Entry
GVP-veterinary practices and GVP-veterinarians shall establish, document and maintain a quality system.
The management shall prepare a quality manual covering the requirements of this Code of Good Veterinary Practices and of all Schedules to it relevant to the veterinary services offered.
The quality manual shall include the quality system protocols and procedures and shall outline the structure and layout of all documentation used.
The quality system protocols and procedures shall be consistent with the requirements of this Code and its schedules and the quality policy.
GVP-veterinary practices and GVP-veterinarians shall ensure that all protocols and procedures are effectively implemented.
6.3. Contract review
GVP Guide Entry
GVP-veterinary practices and GVP-veterinarians shall establish documented procedures for contracts, orders and requests for veterinary services.
Before any contract, order or request is accepted, GVP-veterinary practices and GVP-veterinarians shall ensure that:
- all requirements are adequately defined and understood
- if the requirements are received verbally, they shall be agreed and documented
- all requirements can be met.
6.4. Document and data control
6.4.1. General
GVP Guide Entry
The quality manual shall outline documented procedures to control all documents and data.
6.4.2. Document and data approval and issue
GVP Guide Entry
All documents and data shall be reviewed and authorised by assigned personnel prior to issue. A master list stating the current issues of all documents in the quality system shall be readily available.
All documents shall:
- Be dated and signed for approval
- State the issue version
- Be printed or typed
- Be centrally available and accessible to all personnel
- Be available at the workstations relevant to them
Documented procedures shall be in place to ensure that all invalid or obsolete documents are removed from the system.
6.4.3. Document and data changes
GVP Guide Entry
Changes to any document shall be reviewed and approved by the same personnel responsible for the original issue.
The nature of the changes shall be identified in the document.
6.5. Purchasing / subcontractors
6.5.1. General
GVP Guide Entry
When purchasing products or subcontracting services specific requirements shall be documented and agreed with the subcontractor.
Documented procedures shall be in place to ensure that purchased products, or subcontracted services meet the specified requirements.
6.5.2. Evaluation of subcontractors
GVP Guide Entry
A list of subcontractors shall be kept.
Records of non-conformities regarding delivered goods or services shall be kept.
6.5.3. Purchasing data
GVP Guide Entry
Purchasing documents shall clearly state:
- precise identification of product or service ordered
- the quality requirements
- the quantity ordered
- where applicable adequate reference shall be made to client and patient details.
6.5.4. Verification of purchased product / delivered services
GVP Guide Entry
Documented procedures shall be in place to inspect incoming goods and provided services upon delivery to ensure they meet the agreed requirements.
6.6. Product identification and traceability
GVP Guide Entry
In those cases where product identification or traceability are a requirement, documented procedures shall be in place to ensure those products are suitably identified and traceability is maintained from reception to delivery.
6.7. Process control
GVP Guide Entry
The processes with an impact on the quality of service provided shall be carried out under controlled conditions, which shall include:
- documented work-instructions, where the absence of them could adversely affect quality
- the use of suitable equipment, maintained and, where applicable, calibrated as required by the producer
- compliance with legislation, standards, codes, procedures
6.8. Control of non-conforming product and waste
GVP Guide Entry
Documented procedures shall be established for the storage and the disposition of nonconforming products and waste materials.
6.9. Corrective and preventive action
6.9.1. General
GVP Guide Entry
Documented procedures shall be established and maintained for implementing corrective and preventive action.
Records shall be kept of any changes to documents in the quality system resulting from corrective or preventive actions.
6.9.2. Corrective action
GVP Guide Entry
The procedures for corrective action shall include:
- the effective handling of customer complaints or any other feedback from customers
- dealing with the findings of internal audits
- investigation into the cause of complaints or nonconformities
- determination of the corrective action needed to eliminate those causes
- application of controls to ensure that the corrective action is taken and is effective.
6.9.3. Preventive action
GVP Guide Entry
The procedures for preventive action shall include:
- determination of the steps needed to prevent the re-occurrence of non-conformities
- initiation of preventive action
- application of controls to ensure that the preventive action is taken and is effective
- ensuring that relevant information is submitted for management review.
6.10. Handling, storage, packaging, preservation and delivery
GVP Guide Entry
Documented procedures shall be established for handling, storage, packaging, preservation and delivery of products.
The procedures shall include adequate measures against damage, spillage, deterioration and contamination of or by products.
6.11. Control of quality records
GVP Guide Entry
Documented procedures shall be established for identification, filing, storage, maintenance and disposition of the records related to the quality system.
All such records shall be legible and easily retrievable.
Retention times shall be established and recorded.
Where part of any agreements with customers, records shall be made available to the customer or his representative.
6.12. Internal quality audits
GVP Guide Entry
(these requirements will come into force on 01-01-2003)
Regular internal audits shall be established to verify if all requirements of this Code are met, and whether the quality system is working effectively.
The audits shall be planned upfront and the schedule shall be based on the importance of the activities audited.
A yearly planner of the internal audits shall be available.
The audits shall be performed by authorised personnel, independent of the activities being audited.
The results of the audits shall be recorded and discussed.
Follow-up audits shall be performed to verify if corrective and/or preventive action is taken and effective.
6.13. Training
GVP Guide Entry
(these requirements come into force on 01-01-2002)
All GVP-veterinarians shall spend at least 35 hours per year on continuous professional development.
A record shall be kept stating date, type of material, hours spent on it and a short description of what was gained from the activity.
Sufficient time should be spent on general development, on increasing expertise in the chosen species or field of veterinary science and for the managers in the field they were appointed in.
Other employees shall have the right qualifications for their duties and records shall be kept of their training.
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