6. 9 Proper calibration of all measuring equipment 6.9.1 All measuring equipment which has a direct effect on the production process, safety and quality of the product being manufactured, should be regularly calibrated against a given standard 6.9.2 Results of the calibration should be formally documented and signed and the next due calibration date given, to ensure accuracy of all measuring equipment 6.9.3 Where measuring equipment is taken off site for calibration, provision must be made for"reserve equipment which is also accurate, well maintained and calibrated to be available 6.10 Proper product recall procedures responsible hr t he company must have a formalised, written complaints procedure, detailing the person 6.10.1 ugh whom all product complaints must be channelled 6.10.2 If a person other than the Quality Assurance Manager has been allocated this task, then they must have sufficient product knowledge, experience and authority to implement the appropriate corrective 6.10.3 All quality complaints should be recorded when received (either through verbal or written communication), investigated within a given time scale according to their urgency and a report prepared as the basis for corrective action and for company records 6.104 Corrective action should include responding to the complainant and local enforcement authority if involved. Copies of these letters must be kept on file. Procedures should be implemented to remove the cause of the complaint and therefore prevent its recurrence 6.10.5 Complaints reports should be used to "monitor trends and should therefore be regularly reviewed. They may indicate a potential product recall or a specific problem. Review findings, including comparative data should be regularly distributed to Directors and Senior Management 6.10.6 It is recommended that the company should have a formalised, written product recall procedure, which should be capable of being put into operation at anytime of the day or night 6.10.7 A nominated person, with appropriate authority, should co-ordinate the activities of the named recall" team, under complete confidentiality. That person should be the point of contact with the competent authority. If the media becomes involved, the company must have a designated spokesperson 6. 10.8 The recall procedure should be workable and effective within a reasonable time scale, but must be regularly reviewed in the event of changing circumstances 6. 10.9 The recall procedure should give the precise method of notifying all distribution networks and retailers involved, including contact names and telephone numbers The procedure must be able to halt the transit of products at any stage in the distribution chain 6.10.10 Notification of recall should give full product details, batch code identification, the nature of the defect, the action required and the degree of risk involved 6.10.11 All recalled material at whatever stage of the distribution chain, must be quarantined, clearly labelled as such and held whilst a decision is made as to its destiny6.9 Proper calibration of all measuring equipment 6.9.1 All measuring equipment which has a direct effect on the production process, safety and quality of the product being manufactured, should be regularly calibrated against a given standard. 6.9.2 Results of the calibration should be formally documented and signed and the next due calibration date given, to ensure accuracy of all measuring equipment. 6.9.3 Where measuring equipment is taken off site for calibration, provision must be made for “reserve” equipment which is also accurate, well maintained and calibrated to be available. 6.10 Proper product recall procedures 6.10.1 The company must have a formalised, written complaints procedure, detailing the person responsible through whom all product complaints must be channelled. 6.10.2 If a person other than the Quality Assurance Manager has been allocated this task, then they must have sufficient product knowledge, experience and authority to implement the appropriate corrective action. 6.10.3 All quality complaints should be recorded when received (either through verbal or written communication), investigated within a given time scale according to their urgency and a report prepared as the basis for corrective action and for company records. 6.10.4 Corrective action should include responding to the complainant and local enforcement authority if involved. Copies of these letters must be kept on file. Procedures should be implemented to remove the cause of the complaint and therefore prevent its recurrence. 6.10.5 Complaints reports should be used to “monitor” trends and should therefore be regularly reviewed. They may indicate a potential product recall or a specific problem. Review findings, including comparative data should be regularly distributed to Directors and Senior Management. 6.10.6 It is recommended that the company should have a formalised, written product recall procedure, which should be capable of being put into operation at anytime of the day or night. 6.10.7 A nominated person, with appropriate authority, should co-ordinate the activities of the named recall “team”, under complete confidentiality. That person should be the point of contact with the competent authority. If the media becomes involved, the company must have a designated spokesperson. 6.10.8 The recall procedure should be workable and effective within a reasonable time scale, but must be regularly reviewed in the event of changing circumstances. 6.10.9 The recall procedure should give the precise method of notifying all distribution networks and retailers involved, including contact names and telephone numbers. The procedure must be able to halt the transit of products at any stage in the distribution chain. 6.10.10 Notification of recall should give full product details, batch code identification, the nature of the defect, the action required and the degree of risk involved. 6.10.11 All recalled material at whatever stage of the distribution chain, must be quarantined, clearly labelled as such and held whilst a decision is made as to its destiny