Dear all,
in our company we had MDSAP audit. Auditor checked our special processes in production which are subjects of walidation. He checked Device history records and he realized that there is no parameters or reference to parameters of special processes. He was referencing to the ANVISA RESOLUTION - RDC No.16 OF MARCH 28, 2013 (please see below). According to this statement, it was a nonconformity.
Auditor claimed that the parameters (temperature, humidity, time,...) of special processes (gluing, welding,soldering, cleaning S,...) for each component shall be written OR referenced in the DHR.
What do you think about it? Do you understand this as a reference to the parameters in the validation for each proces, or do you understand this that each operator will have to record the parameters each time he performs an action and this record should be referenced in the DHR even if the process is validated and equipment is calibrated?
ANVISA RDC statement:
3.2.1. Each manufacturer shall maintain device history records. Each manufacturer shall establish and maintain procedures to ensure that the device history records are kept for each batch or series to demonstrate the products were manufactured according to the device master record and the requirements of this Technical Regulation. The device history record shall contain or make reference to the following information:
3.2.1.1. Manufacture Date;
3.2.1.2. Components used;
3.2.1.3. Quantity manufactured;
3.2.1.4. Results of tests and inspections;
3.2.1.5. Special processes parameters;
3.2.1.6. Quantity released for distribution;
3.2.1.7. Labeling;
3.2.1.8. Identification of serial number or batch of the device; and
3.2.1.9. final release of the device.
Thank you very much,
Best regards