standard operating procedure machine history file
To define a procedure for maintaining history in case of any minor/major changes/modifications done in the critical Machines.
2.1 This procedure applies to all critical machine used for various stages of dispensing, manufacturing and packing of formulations and machines used for supply of utility services for production activities
3.0.1 No. : Number
3.2.1 EHS : Environment, Health and Safety
3.2.2 SOP : Standard Operating Procedures
4.1 User Department:
4.1.1 To fill and maintain the Machine history file.
4.2 Quality Assurance Head:
4.2.1 To ensure implementation of the defined procedure.
4.3 Plant Head:
4.3.1 To ensure implementation of the defined procedure.
I. Quality Assurance
II. Quality Control
IV. Ware house
6.1 After installation and subsequent handover of the machine for regular use, the ‘Machine History file’ shall be maintained with details of any minor/major changes/modifications with reason as per Attachment-I.
6.2 The changes made shall be recorded whenever changes or modifications are carried out.
6.3 On completion of minor/major changes/modifications the machine shall be cleaned as per respective machine cleaning (product changeover cleaning if applicable) SOP.
6.4 Machine shall be certified by Production, Engineering, EHS and Quality Assurance department for proper setting and operation to get zero defect before use of machine for Production activities.
6.5 After rectification of all critical and major breakdowns, the machine shall be re-qualified as per SOP “Qualification of Equipment”.
7.0.1 SOP : Qualification of Equipment
8.1.1 Attachment- I: Machine History file