Assignment:
You are working in a corporate environment as a Manager. Recently your team expanded, and you
employed an additional 10 team members in the role of Project Quality Risk Leads (PQRLs) to join your
team. You need to train these team members to ensure that they perform specific tasks according to a
standard process to ensure that your output stays consistent irrespective of which team member is
performing the task.
Each Monday a general follow-up is required on outstanding Quality Issues (QIs)/Corrective Preventive
Actions (CAPAs). The PQRL arrives at the office on Monday morning and gets settled in. Once the
computer has been turned on the PQRL gets up walks to the canteen and makes some coffee. The PQRL
prefers 2 units coffee, one unit milk and 2 units sugar. Once the coffee was prepared the PQRL walks back
to their desk and open Outlook as well as the QI/CAPA system. From the QI/CAPA system the PQRL runs
a report on all open QIs/CAPAs. Once this report was generated the PQRL filters the report according to
CAPA/QIs due soon, CAPA/QIs overdue by less than a month, QI/CAPAs overdue by more than one month.
The PQRL then prepares an e-mail for action owners on CAPA/QIs that are due soon, informing them of
the upcoming actions and due dates. The e-mail is formulated with reminder functionality to ensure that
the recipients receive a reminder of their tasks which are due soon. The next e-mail which is prepared is
the e-mail to action owners whose QIs/CAPAs are overdue by less than month. These action owners are
being told that once the open actions reach 30 days without closure these actions will be escalated. The
last e-mail to be generated is the one of QIs/CAPAs overdue by a month. These action owners are added
to the e-mail, but the e-mail is escalated to their line managers and senior leadership.
1. Based on an interview you had with a PQRL you documented the above process – please list the
core process by bullet list which each PQRL must follow to ensure standardization between all
PQRLs
2. Once you documented the standard core process, please develop a visual workflow of the
process which could be a training aid for the PQRLs (see example below). This can be drawn by
hand; please ensure you write clear.