How is Covid-19 impacting your outsourcing responsibilities?
During the next few months we will all be unable to travel to the extent that we originally planned. We will have to explore alternative ways to fulfil regulatory requirement in order to do our part in reducing the impact of the spread of the coronavirus.
Audit or Vendor Qualification?
Vendor qualification of contract manufacturing organisations (CMO) and contract test facilities is often considered to be an on-site audit, audit report with observations and check on the auditee’s audit responses. However, audit is only a part of vendor qualification, as illustrated in the process flow. By taking a step back, and considering the vendor qualification process, we may be able to reduce face to face interactions.
Is a visit to site avoidable?
The vendor qualification process should focus on the scope of activities conducted by the manufacturer and the impact those activities may have on the quality of product to identify needs and risks. A thorough initial assessment will direct further assessment or audit activities that may be needed. Liaison with the vendor will determine whether they have the technology to allow any of these activities to be conducted remotely which may reduce, postpone, bring forward or eliminate the necessity for attendance on site.
How are you fulfilling your outsourcing responsibilities?
We can help you design and document your supplier qualification process and perform supplier qualification and audit activities on your behalf.
Contact us to arrange a no obligation discussion (firstname.lastname@example.org)