Internal audits are important within the manufacturing facility to recheck the existing system and to give assurance that an organisation's internal controls are .operating effectively.
The first thing an organisation shall do in respect of self inspection is to lay down a procedure for carry out self inspection/internal audit of various departments and processed.
1. Self Inspection/Internal audit shall be conducted in order to
a) Monitor and determine the implementation and compliance with quality, food safety and cGMP.
b) To monitor and determine the adherence to SOPs and regulatory requirement.
c) To prepare necessary corrective action.
d) To improve the awareness and responsibility of the personnel.
2) Selection of an audit team:
a) The audit team may be of one or more individuals.
b) Audit may also be subcontracted to consultants.
c) In a team of more than one personnel a lead audit is also appointed.
The leader is the overall responsible for conducting an audit and allocates work to other team members. He shall not depute the audit team to audit his or her own department /activity.
3) Frequency
a) A frequency to conduct the audit shall be fixed. Some of the manufacturing companies audit their departments on monthly basis, some on quarterly basis, some companies prefer to keep on six monthly basis and some keeps on annual basis.
Audits with frequency exceeding annually is questionable,
4) Deficiency identified during the internal audit may be categorised as
a) Major
b) Minor
c) Critical
5) After completion of audit or self inspection the auditor shall prepare the audit report and circulate it with the department.
6) The auditee shall submit a corrective action plan to be shared with auditor to be reviewed.
AUTHOR
Anshu Yadav
anshuyadav.icgian@gmail.com
