Deviation Management Workflow

Why should we automate deviation management instead of tracking it in spreadsheets or email threads?

Spreadsheets and email chains make it hard to see which deviations are open, who owns the next step, and what was decided at each stage. This workflow creates a single record per deviation with a reference number, status and timeline, so quality staff and management can see progress at a glance in table views and dashboards. Reporters are also kept informed automatically, removing the need for staff to manually chase or update them.

What is the ROI of using this workflow compared to handling deviations manually?

Manual handling typically involves someone drafting acknowledgement emails, chasing severity assessments, and manually compiling investigation notes and disposition letters. This workflow removes that administrative overhead by sending acknowledgement and closure emails automatically and by saving each task's inputs directly to the record. The time saved on coordination and status chasing can be redirected to the actual quality assessment and investigation work.

Who is involved in the deviation process, and what do they each do?

Quality assesses severity and impact within a defined window, a quality reviewer records disposition and rationale for minor deviations or reviews investigation results for major ones, an investigator records root cause and corrective actions with owners, and corrective action owners confirm when their actions are complete. Each of these is a task assigned to a workspace member, and the workflow waits for the assigned person to complete it before moving to the next step.

How does the workflow decide between a minor disposition and a full investigation?

After quality records the severity assessment, the workflow routes the deviation based on the Severity value entered. A Severity of Minor sends the deviation to a quality reviewer for disposition and rationale, while a Severity of Major sets the status to Investigating and starts the root cause investigation path. Any other severity value follows an 'otherwise' path in the routing step.

What happens if the quality reviewer decides the investigation needs more work?

After the quality reviewer records their Review Result and Comments, the workflow routes based on that result. If the result is 'More investigation needed', the current investigation task is closed and a new investigation task is started for the investigator, and this can repeat up to two times before proceeding. If the result is 'Approved', the process moves forward to corrective action completion.

How is the reporter kept informed throughout the process?

The reporter receives an acknowledgement email with their deviation reference number as soon as the record is created. Depending on the severity path, they later receive an email with the final disposition once a minor deviation is closed or once a major deviation's corrective actions are completed and the record is closed.

Can this workflow be adapted if our deviation process has different timeframes or approval steps?

Yes, a workflow can be changed by describing the change in plain English or by editing its steps directly in the workflow editor, and earlier versions are kept so changes can be tracked over time. This makes it straightforward to adjust task deadlines, add fields to the request form, or change the routing logic as your process evolves.

What information is captured on the deviation record, and where is it stored?

Fields from tasks the workflow waits for, such as Severity, Impact Assessment, Disposition, Rationale, Root Cause, Corrective Actions with Owners, Review Result and Corrective Actions Completed, are saved directly to the record. Each record also carries a reference number, current status and a timeline showing what happened, which businesses can review to confirm their own quality documentation needs are met.

Do reporters need an account to submit or track a deviation?

No, reporters submit their deviation through a public request form and receive updates through emails sent to them, without needing to create or log into an account. This makes it easy for anyone in the affected process to raise a deviation without additional setup.

Can corrective action owners work without a fixed deadline?

Yes, the Complete Actions task assigned to corrective action owners has no due date, allowing them to record completed corrective actions when the work is genuinely finished rather than against an arbitrary deadline. The workflow waits for their input before saving the completed actions and setting the deviation status to Closed.