Summary
In short
- An effectiveness verification is a record used in General that checks whether an action actually worked, some time after it was put in place. It is built against ISO 9001 cl.10.2 and forms part of the Incident and Investigation programme.
- Scheduled 30 to 180 days after the action is completed. Carried out by someone other than the action owner.
- The template holds 19 fields across 4 sections.
- Scoring is pass or fail, where high is good.
- ISO 9001 is quality management systems. The international standard for consistently meeting customer and regulatory requirements. Certifiable.
- It connects to the rest of the library: linked from CAPA.
What it is
What it is
What is an effectiveness verification?
An effectiveness verification is a record used in General that checks whether an action actually worked, some time after it was put in place. It is built against ISO 9001 cl.10.2 and forms part of the Incident and Investigation programme.
When is an effectiveness verification completed?
An effectiveness verification is completed at the moment the event happens, rather than reconstructed afterwards. Scheduled 30 to 180 days after the action is completed.
When to use it
When to use it, and when not to
This record is one step in a larger programme. Using it for work that belongs to a neighbouring template produces records that are hard to report on later.
Use it for
- The event or activity this record covers has occurred, or is about to
- The workspace is being set up, or the register needs an entry added or retired
- You are running the Incident and Investigation programme and this is one of its steps
- A linked record needs this one to exist: linked from capa
Not for
- Risk Assessment, which the single risk assessment used across the whole business.
- Root Cause Analysis, which finds out why something happened rather than who was involved.
- Corrective and Preventive Action, which the single action record used everywhere.
- Anything outside General, which belongs in the workspace that owns that process
Standards
What it is built against
ISO 9001Quality management systems
The international standard for consistently meeting customer and regulatory requirements. Certifiable.
ISOInternational Organization for Standardization
A voluntary international standard. Widely adopted, often required by customers, and certifiable where a management system standard.
FAQ
Frequently asked questions
What is the effectiveness verification template based on?+
It is built against ISO 9001 cl.10.2. ISO 9001 is quality management systems. The international standard for consistently meeting customer and regulatory requirements. Certifiable. ISO is international Organization for Standardization. A voluntary international standard. Widely adopted, often required by customers, and certifiable where a management system standard.
What sections does the effectiveness verification contain?+
There are 4 sections: header, method, result, outcome. Together they hold 19 fields, 13 of which are required.
How many effectiveness verification records should we have?+
This is a singleton. One record per workspace, set up once and maintained, rather than one per event. Other templates refer back to it.
Which programme does the effectiveness verification belong to?+
It is part of Incident and Investigation, Internal Audit and Certification, Master Data and Foundations. A single case thread from the event to a verified corrective action, with regulatory reporting handled.
How is an effectiveness verification scored?+
Scoring is pass or fail. High is good. Scores exist to make the form tell you something, not to produce a percentage for its own sake.
Can the effectiveness verification template be changed?+
Yes. Every field, option, score and conditional rule is editable, and the links to other templates come with it. Most teams install it as it is, run it for a cycle, then adjust.
The agents
What the agents do with it
The form is the easy part. Keeping it current, routing it to the right owner and holding the evidence together is the work that actually slips.
Holds the effectiveness verification library against your registers, routes each record to its owner, and keeps the evidence trail together.
Coordinates the crew, rolls completion and exceptions into one view, and holds every write for your approval before it touches a record.
This template lives in General — control tower. The orchestration layer. Registries and engines every other workspace reads from.
Meet General→Sources
Sources
- ISO 9001 — Quality management systems
- ISO — International Organization for Standardization