Knowella

Setup Approval Record

Confirms a new setup is correct and approved before the run continues past the first pieces. Completed at every setup. Signed by the operator and quality. Prevents a full run being made to the wrong settings.

KnowQualityRecordQUA-060
Completed by
Signed by the operator and quality
Raised
At the moment the event happens, rather than reconstructed

Summary

In short

  • A setup approval record is a record used in KnowQuality that confirms a new setup is correct and approved before the run continues past the first pieces. It is built against ISO 9001 cl.8.5.1 and forms part of the HACCP and Food Safety programme.
  • Completed at every setup. Signed by the operator and quality.
  • The template holds 38 fields across 4 sections, with settings verification repeating for each entry.
  • 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: links Asset, First Article.

What it is

What it is

What is a setup approval record?

A setup approval record is a record used in KnowQuality that confirms a new setup is correct and approved before the run continues past the first pieces. It is built against ISO 9001 cl.8.5.1 and forms part of the HACCP and Food Safety programme.

When is a setup approval record completed?

A setup approval record is completed at the moment the event happens, rather than reconstructed afterwards. Completed at every setup.

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
  • A new record is needed; each one gets its own ID in the form SETUP-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, first article

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.
  • Process Capability Study, which measures whether a process can reliably hold its specification, using data from a stable run.
  • Anything outside KnowQuality, 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 setup approval record template based on?+

It is built against ISO 9001 cl.8.5.1. 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 setup approval record contain?+

There are 4 sections: header, settings verification, tooling and materials, release. Together they hold 38 fields, 32 of which are required.

How often is a setup approval record raised?+

A new record is raised at the moment the event happens, rather than reconstructed afterwards. Each one is given an ID in the form SETUP-2026-000, so it can be traced and referenced from other records.

Which programme does the setup approval record belong to?+

It is part of HACCP and Food Safety. A HACCP system an auditor can follow from hazard to record without asking a single question.

How is a setup approval record 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 setup approval record 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.

KnowQuality

Holds the setup approval record library against your registers, routes each record to its owner, and keeps the evidence trail together.

Ella

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 KnowQualityquality and food safety. HACCP, nonconformance, traceability, laboratory and customer complaints.

Sources

Sources

  • ISO 9001 — Quality management systems
  • ISO — International Organization for Standardization

KnowQuality

Also in Process Control

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Plan

Control Plan

Sets out what is measured on a process, how often, by what method and what to do when it goes out of limits. Written per product or process family. Owned by quality engineering. Drives the inspection frequencies used everywhere else.

Log

Statistical Process Control Log

Records measurements over time so process variation can be seen and acted on before product fails. Completed at set intervals. Carried out by the operator. Out of control patterns trigger action even when every reading is still in specification.

Assessment

Process Capability Study

Measures whether a process can reliably hold its specification, using data from a stable run. Run at qualification and after significant change. Carried out by quality engineering. Tells you whether to fix the process or widen the specification.

Record

Batch Record

Records everything that happened during the production of one batch, including materials, settings, checks and people. Completed through the run. Reviewed and signed by quality before release. This is the document a regulator or customer asks for by batch number.

Record

Yield Analysis Record

Compares material in against product out and accounts for the difference. Completed per batch or per shift. Carried out by production with quality. Unexplained yield loss often points to a process problem long before it shows up as a defect.

Record

Shift Handover Record

Passes on what the incoming shift needs to know, including running issues, holds and changes. Completed at every shift change. Signed by both supervisors. Most quality problems that cross a shift boundary start with a handover that did not happen.

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