Hi
Which dept is responsible for auditing - i get so confused is it qa or compliance? some companies dont even have a compliance department everything is shoved under the title of QA - anyone help thanks?
Regards
Donie
It really doesn’t matter what you are going to call the department, QA or Compliance. In smaller organizations, you would typically find QA Auditor, in larger-compliance auditor.
What’s important to keep in mind is the independence of the auditor from day to day operations. Also, there should be another body to audit the auditors.
Quality Assurance is typically responsible for product release (and other stuff), while Quality Auditor is responsible for ensuring that the company complies with all applicable regulations.
Typically, you would want to see the auditor directly reporting to a high level VP or President in smaller companies. Again, in day to day operations or in the reporting company hierarchy, there should be no conflict of interest.
Regards
Hai Donie,
Normally Quality management is responsible for conducting self inspections of the firm. Depending upon the size and structure of the organization, Quality management may subdivide into specific functions like Audit&Compliance, validations team etc.
Pl.note that, under any circumstances the auditee should have sufficient functional knowledge on the area auditing and independent of the area he is auditing.
Regards,
Lakshman
[quote=admin]It really doesn’t matter what you are going to call the department, QA or Compliance. In smaller organizations, you would typically find QA Auditor, in larger-compliance auditor.
What’s important to keep in mind is the independence of the auditor from day to day operations. Also, there should be another body to audit the auditors.
Quality Assurance is typically responsible for product release (and other stuff), while Quality Auditor is responsible for ensuring that the company complies with all applicable regulations.
Typically, you would want to see the auditor directly reporting to a high level VP or President in smaller companies. Again, in day to day operations or in the reporting company hierarchy, there should be no conflict of interest.
Regards[/quote]
[quote=donalg]Hi
Which dept is responsible for auditing - i get so confused is it qa or compliance? some companies dont even have a compliance department everything is shoved under the title of QA - anyone help thanks?
Regards
Donie[/quote]
It really doesn’t matter or come down to the name of any department in any company.
At the end of the day; it is the ‘Lead Auditor’ of the audit team itself who is ultimately responsible for conducting and reporting on the audit! As a matter of fact, I’m doing this right now out in Italy.
Audit is a joint responsibility of both production and QA,so in most of the company they use to have a self-audit team which includes QA,Production and engineering(sometimes).
Thanks
Amit:o:mad:
Resposibilty of Auditing will be all section of pharmaceutical organisation.
Compliance section must be isolated from other section.
Why should be Compliance section or department Isolated from others?
Normally the quality and compliance department will be at corporate offices always looking into various files and even regulatory documents. They have weekly, monthly and annual audit plans. They will visit, audit and give the audit findings, CAPAs and also train the staff and lower management.
Transparency is the key for success in pharma units.
Lot of co-ordination and co-operation is needed between departments.