Quality system
These are the controls that stand between a raw instrument file and an issued HDChroma certificate. They are described here in the same terms they are implemented in the laboratory record system.
Data practice
Controls
A sample record is opened at receipt with the condition observed on arrival, packaging integrity, temperature indication where applicable, and quantity received. Storage location and every subsequent handling event — analyst assignment, aliquoting, return to storage — is appended as a timestamped event. The custody timeline is visible to the client for their own samples.
Quantitative results are traceable to a characterised reference standard. The standard identifier, assigned value basis and expiry or re-evaluation date are recorded with the run and the identifier is reproduced on the certificate. Where a client supplies their own standard, that is stated explicitly rather than presented as laboratory-traceable.
Each determination references an internal method code and version. Methods carry a technique, defined analyte scope, reporting unit, reporting limit and default acceptance criteria. When a method changes, a new version is issued; historical certificates continue to reference the version in force at the time of testing.
Instruments used for a determination are recorded against the run, together with system suitability outcomes where the method requires them. Calibration and maintenance history is maintained for each instrument and reviewed as part of release.
Instrument files, integration parameters and calculation worksheets are retained and referenced from the certificate record by internal identifier. Raw data is not published with the public certificate; it is made available to the client of record and to authorised auditors under the terms of the engagement.
The analyst who produced the data cannot release it. A separate quality reviewer examines the data package against the method and the certificate content, and either approves and issues, or returns it with mandatory written comments. Approval locks the version, calculates a SHA-256 fingerprint of the certificate data and assigns the sequential certificate number.
An issued certificate is never edited. If a correction is required, a new version is created and issued; the prior version is retained and marked superseded, and the change reason is written to the audit trail. A certificate may also be revoked, with a mandatory reason, after which public verification reports it as revoked rather than simply disappearing.
Record retention periods are configured by laboratory management in the administrative settings and are stated in the engagement documentation rather than asserted globally on this page. Retention terms applicable to your work are available upon request.
HDChroma does not generate results, dispositions or pass/fail outcomes automatically. Every reported value is entered by authorised laboratory staff and reviewed by a second person before release. Where a determination was not performed, or a value is not available, the certificate reports it as not tested or not reported rather than leaving an inference open.