Summary
In short
- A process capability study is an assessment used in KnowQuality that measures whether a process can reliably hold its specification, using data from a stable run. It is built against ISO 22514 and forms part of the HACCP and Food Safety programme.
- Run at qualification and after significant change. Carried out by quality engineering.
- The template holds 42 fields across 4 sections.
- Scoring is cpk value, where high is good.
- ISO is international Organization for Standardization. A voluntary international standard. Widely adopted, often required by customers, and certifiable where a management system standard.
- It connects to the rest of the library: links Asset, Control Plan.
What it is
What it is
What is a process capability study?
A process capability study is an assessment used in KnowQuality that measures whether a process can reliably hold its specification, using data from a stable run. It is built against ISO 22514 and forms part of the HACCP and Food Safety programme.
When is a process capability study completed?
A process capability study is completed when the task, area or population being assessed is new or has materially changed. Run at qualification and after significant change.
When to use it
When to use it, and when not to
This assessment 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 assessment covers has occurred, or is about to
- A new record is needed; each one gets its own ID in the form CAP-2026-000
- You are running the HACCP and Food Safety programme and this is one of its steps
- A linked record needs this one to exist: links asset, control plan
Not for
- Control Plan, which sets out what is measured on a process, how often, by what method and what to do when it goes out of limits.
- Statistical Process Control Log, which records measurements over time so process variation can be seen and acted on before product fails.
- Setup Approval Record, which confirms a new setup is correct and approved before the run continues past the first pieces.
- Anything outside KnowQuality, which belongs in the workspace that owns that process
Standards
What it is built against
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 process capability study template based on?+
It is built against ISO 22514. 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 process capability study contain?+
There are 4 sections: header, preconditions, results, conclusion. Together they hold 42 fields, 30 of which are required.
How often is a process capability study raised?+
A new record is raised when the task, area or population being assessed is new or has materially changed. Each one is given an ID in the form CAP-2026-000, so it can be traced and referenced from other records.
Which programme does the process capability study belong to?+
It is part of HACCP and Food Safety, Statistical Process Control. A HACCP system an auditor can follow from hazard to record without asking a single question.
How is a process capability study scored?+
Scoring is cpk value. High is good. Scores exist to make the form tell you something, not to produce a percentage for its own sake.
Can the process capability study 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 process capability study 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 KnowQuality — quality and food safety. HACCP, nonconformance, traceability, laboratory and customer complaints.
Sources
Sources
- ISO — International Organization for Standardization