Audits and regulatory compliance

Each question carries 10 marks

Roll No. Assignment topic

19L81S0401 A Top down approach is commonly employed method by the
auditors for auditing. Is this a best method than bottom up approach
Justify with suitable reasons.
19L81S0402 An audit of an organization X failed due to improper implementation
of quality systems. Identify the various systems that can be improved
for re-audit.
19L81S0403 After an audit of X company, the auditor classified the report under
major deficiency and during closing meeting suggestions were given
to focus on tablet production process. Is there necessity for re-audit
and what are the possible corrections to be made and implemented
for re-audit/next audit.
19L81S0404 After an audit of Y company, the auditor classified the report under
critical deficiency and during closing meeting suggestions were
given to focus on sterile production process. Is there necessity for re-
audit and what are the possible corrections to be made and
implemented for re-audit/next audit.
19L81S0406 A Lead auditor during closing meeting of an audit made few
suggestions and classified the audit report under minor deficiency
due to improper maintenance of HVAC, ETP and its documentation.
Identify the possible sources and reasons to rectify the same.
19L81S0407 After an audit of Z company, the auditor classified the report under
minor deficiency and during closing meeting suggestions were given
to focus on Engineering process (Granulation equipments) and its
documentation. Is there necessity for re-audit and what are the
possible corrections to be made and implemented for re-audit/next
audit.
19L81S0408 Audit breakdown occurred after auditing microbiology laboratory of
B company and many suggestions were given to improve the system.
Enlist the improvements to be made and are there any chances of re-
audit.
19L81S0409 During Pre-audit meeting the Z company manager clearly outlined
the objectives and scope to the audit team. But the audit failed and
classified under critical deficiency by lead auditor during auditing.
Identify the reasons.
19L81S0410 During a pre-audit meeting the auditing committee suggested to have
questionnaire for evaluation. What are the parameters that need to be
included and suggest any better approach other than representation
in the form of questionnaire.