QA / QC Consultancy & Secondment

ISO/IEC 17025 accreditation demonstrates that a laboratory is technically competent to perform activities within its accredited scope and can strengthen confidence in the reliability of its results. For organisations developing accredited in-house testing capability, it can also reduce reliance on external laboratories and shorten testing turnaround times. BlueXPRT can help assess whether accreditation is commercially justified, define an appropriate scope and prepare the laboratory for assessment.

No. Not every laboratory needs ISO/IEC 17025 accreditation. It is most valuable where accreditation is required or expected by customers, regulators or tenders, or where the importance and volume of testing justify it. BlueXPRT can help determine whether full accreditation, ISO/IEC 17025-aligned quality improvements or targeted technical support is the most appropriate route.

Method validation demonstrates that an analytical method is fit for its intended use. It is typically required for laboratory-developed, non-standard or modified methods, and may also be needed following significant changes to matrices, instruments, software, measurement ranges or the intended application. BlueXPRT can support validation planning, data evaluation and validation reporting.

Yes. A specific analytical-method problem can often be addressed without starting a broader quality-system project. BlueXPRT can focus on individual issues such as poor precision, unexpected bias, low recovery, calibration problems, matrix interference, unsuitable reporting limits, weak linearity, instrument differences or unclear acceptance criteria. The aim is to identify the cause and develop a technically sound, practical and documented solution.

Yes. BlueXPRT can investigate potential sources of variation, including sampling, sample preparation, matrix effects, calibration, reagents, instrument performance, analyst technique, calculations and QC design. Support can include data review, root-cause analysis, experimental planning and corrective actions to improve the reliability of analytical results.

Yes. BlueXPRT can design and statistically evaluate comparison studies across instruments, analysts, shifts, sites or external laboratories. These studies help determine whether analytical results are sufficiently comparable and consistent for product, process, release or compliance decisions.

An effective QC programme should detect meaningful changes in analytical performance before they affect important decisions. BlueXPRT can review control samples, blanks, reference materials, duplicates, control charts, acceptance criteria, trends and response actions, and recommend a practical, risk-based approach to QC.

A failed QC result or adverse trend should be contained and investigated rather than simply repeated. BlueXPRT can help determine the cause, assess the potential impact on previous results, define appropriate corrective actions and establish the objective evidence needed to close the issue.

Repeat testing, invalid results and analytical rework can indicate weaknesses in methods, sample handling, instrument control, training, calculations, QC or review processes. BlueXPRT can identify the main causes and implement targeted improvements to reduce wasted time, cost and laboratory capacity.

Yes. BlueXPRT can help assess whether previous results, product decisions or compliance data may have been affected, define a proportionate retrospective review, and determine appropriate corrective actions, retesting needs and follow-up controls.

Strong QA/QC helps reduce the risk of unreliable results, unnecessary repeat testing, delayed release, incorrect acceptance or rejection decisions, audit findings and operational disruption. Effective QA/QC focuses on practical, proportionate controls that support reliable laboratory decisions without creating unnecessary work.

BlueXPRT can conduct a gap assessment or internal audit, review technical evidence and records, prioritise required actions, support CAPA closure and prepare staff for assessment or audit interviews. Support is tailored to the laboratory’s scope, risks and timeline.

External QA/QC support provides specialist expertise when it is needed, for example for technical investigations, audit preparation, method validation, specific projects or temporary workload peaks. It can provide additional capacity without recruitment delays while transferring knowledge and long-term ownership to the internal team.

External QA/QC support can be valuable when quality issues affect turnaround time, product or process decisions, compliance, audit readiness or internal capacity. Typical triggers include accreditation projects, recurring deviations, new methods or equipment, staff absence, increased workload and audit-action backlogs.

Start with a confidential discussion about the laboratory’s activities, current challenge, desired outcome, timeline and internal capacity. BlueXPRT can then recommend the most appropriate level of support, such as a focused technical review, method-improvement project, audit-readiness support, broader quality management system programme or temporary secondment.