Vault QMS supports the ability for a user to perform and document a 5 Whys root cause analysis of a Quality Event, Complaint, Deviation, Lab Investigation or Finding.
A 5 Whys analysis is a common cause-effect technique used to perform root cause analysis. The general approach is to start with your problem statement and ask “why” after each answer, forming the basis of the new “why” until you clearly identify the root cause.
5 Whys Analysis Tool
If enabled by an Admin, Vault QMS includes the Root Cause Analysis Tool, which allows you to perform and document a 5 Whys Analysis in an easy-to-use interface. While the event which triggers a Root Cause Analysis will vary depending on your organization’s quality processes, the Vault QMS 5 Whys Analysis tool is flexible and allows for a wide breadth of analysis variations. As you add Whys, Root Causes, and other information to the tool, a tree forms, showing your path and justifications.
Performing a 5 Whys Analysis
Follow these steps to perform a 5 Whys Analysis in Vault QMS:
- From the originating record, such as a Quality Event, Complaint, Deviation, Finding or Lab Investigation, navigate to the Root Cause Analysis section.
- Click into the appropriate Root Cause Analysis record or create a new record.
- Enter a Problem statement.
- Use the 5 Whys Analysis Tool section interface to continue or complete your analysis against that Problem statement.
- Once you have completed your analysis, follow your business processes to move the Root Cause Analysis record to the Completed lifecycle state type. In some cases, this may include performing a user action on the Root Cause Analysis record.
When a Root Cause Analysis record enters the Completed lifecycle state type, Vault automatically creates Root Cause records of the appropriate type, if applicable, for each root cause identified in the Root Cause Analysis Tool, and data from individual Root Cause Analysis Item records is transferred to the automatically generated Root Causes. Any data transferred in this manner cannot be edited later unless the user re-opens the analysis and updates the data via the interface.
If you re-open the analysis and change a Root Cause value from Yes to No or Not Determined, the previously created Root Cause record is removed. If you change the Root Cause object type to another value, the previously created Root Cause record is removed and recreated as the new type with the new data associated to that object type.
The Root Cause Analysis Tool section is a flexible interface for performing and documenting a 5 Whys analysis. You can collapse or expand each box within the section to manage your view. The percentage drop-down in the top right of the section determines the zoom level.
Adding a Why
The basic component of a 5 Whys analysis is a Why? question and answer, along with a determination as to whether that answer is the root cause. To add a Why? box:
- Click + Why.
- Enter an answer statement.
- In the Root Cause drop-down, select No, Yes, or Not Determined:
- No: Allows you to add new Why? boxes underneath the current box by clicking the plus (+) icon.
- Yes: Allows you to enter additional information pertinent to the root cause. This information will be populated on the resulting Root Cause record created when the Root Cause Analysis enters the Completed lifecycle state type.
- Not Determined: Allows you to enter a justification reason as to why this line of Whys may not result in a definitive root cause.
- Click anywhere within the tree and outside of the Why? box to save the data entered and proceed.
Expanding the Analysis
Anytime during the analysis, you can expand into a new line of Whys, discard Why boxes if they are unhelpful using the trashcan icon, or branch a line of Whys by clicking the plus (+) icon in an upper-level box. The Root Cause Analysis Tool supports up to ten (10) simultaneous trees, with up to 20 boxes in each one.
When you delete a Why? box, Vault renumbers any remaining boxes automatically. Deleting a Why? box also deletes boxes below it in the tree.