Solution
Traceability and quality documentation
Every measured value linked to part, order, serial number and operator, with events and reports that hold up in an audit.
The problem
When a customer complains or an auditor asks, you need to be able to show quickly what was produced, how it was inspected and what was done when something deviated. If the answer is in binders and e-mails, it takes days.
Relevant for: Quality, Management
The context in production
Traceability means that every measured value and every event can be tied to the right part, order, serial number, machine and person. It is the foundation of quality management systems such as ISO 9001 and of industry requirements in, among others, automotive and medical devices.
In regulated environments, such as pharmaceuticals and medical devices, there are also requirements that changes to data are logged and can be reviewed, for example according to FDA 21 CFR Part 11.
Why it matters
Without traceability a complaint becomes more expensive: you cannot limit which parts are affected, so more has to be sorted or recalled.
Documentation that can be trusted is also a sales argument. It shows the customer that you are in control.
In principle
The context that makes a value traceable
A measured value becomes traceable when it is saved with order, serial number, operator and gauge. From that, a report per order can be produced that answers the questions of the customer and the auditor.
Why do annotations make a measured value more useful?
Illustration · Example dataA value without context can only be compared with its limit. With operator, serial number, order, machine and cavity it can be filtered, compared and traced.
Step by step
- The value 12.51 is linked to operator, serial number, order, machine and cavity.
- The cavity number makes it possible to compare cavities with each other.
- Serial number and order make it possible to trace a single part and answer the customer.
What does an inspection report contain, and what can it show?
Illustration · Example dataA report is only as good as what was recorded while the order ran. What was not saved with the value, such as order, gauge or a note, cannot be added afterwards.
Step by step
- During the order, measured values per characteristic, order, part and time, who measured and with which gauge, and notes on deviations are recorded.
- The report per order is identified by customer, part, order and date, and shows per characteristic the nominal value, lower and upper tolerance limit, count, min, max and Cpk.
- In the example the width has Cpk 1.12, below the customer's requirement of 1.33, even though every part is within tolerance.
- The report answers the customer's question of whether the requirements were met, the auditor's question of how and by whom it was inspected, and quality's question of what to act on first.
From today to better
Common challenges, and what a better way of working looks like
What it often looks like
- Measured values are saved without a link to order or serial number.
- Deviations and actions are documented in e-mails or notes.
- It takes a long time to produce the history before an audit.
- Unclear who changed what, and when.
A better way of working
- Every measured value is tagged with the relevant information when it is recorded.
- Deviations and production events are logged in the same system as the measurement data.
- The history is searchable and can be presented as a report.
- Changes and permissions are controlled and logged.
Rektron's approach
How we help
In Eyesight, measured values are tagged with annotations such as operator and serial number, and deviations and events are recorded in a logbook. Reports and certificates are produced from the same data, and permissions are controlled per role.
For organisations with requirements under FDA 21 CFR Part 11 there is an edition of Rektron SQC with support for audit trail and access control.
Capabilities used
Traceability and logbook
EyesightEvery measured value is tagged with, for example, operator and serial number. Deviations and production events are recorded in a logbook.
Reports and certificates
EyesightInspection instructions, inspection reports and quality certificates, plus your own report templates in a report designer.
Access control
EyesightExtended control of who sees and does what, per role and unit.
Quality control
EyesightIncoming, first/last-off, in-process and final inspection with inspection instructions right in the interface.
Read more →Audit trail with support for FDA 21 CFR Part 11
SQCEdition of Rektron SQC with access control and audit trail for regulated environments.
Read more →
The flow
How it works
- 01
Record
The value is saved with part, order, serial number and operator.
- 02
Log
Deviations and events are documented where they occur.
- 03
Search
The history can be filtered by order, period, machine or characteristic.
- 04
Show
Reports and certificates are produced for the customer or the audit.
What changes
- Quick answers in complaints and audits.
- Limiting the affected parts instead of broad sorting.
- Documentation that shows the customer you are in control.
Read more
- Customers and references →
Companies that work with Rektron systems.
- The knowledge base →
The methods behind the solution, explained.
Technical information
- Metadata fields (annotations) per measured value.
- Logbook for deviations and production events.
- Extended access control.
Situations
Where this becomes relevant
The situations are described without the product: what happens, what should apply and who needs to know what.
Situation
A part measures outside tolerance
At inspection a value lands outside the limit. Is it the part, the process or the measurement?
Read about the situationSituation
The customer wants to see the requirement was met
A complaint or an audit. Can you show what was made and how it was inspected?
Read about the situation
Knowledge
Concepts on this page
Questions
Frequently asked questions
Does Eyesight meet FDA 21 CFR Part 11?
Support for audit trail according to FDA 21 CFR Part 11 is available today in an edition of Rektron SQC. Contact us and we will go through your requirements and which set-up fits.
Related
Solutions that fit together
Next step
Want to see how traceability and documentation can work for you?
Tell us about your process and your measurements. We will suggest a first step that suits your business.