Laboratory quality and certification management system
The quality team follows the fitness checks and flaw correction of methods, equipment and personnel. The certification activities additionally manage the decision and validity of the issued document.
Employee credentials, methods competence, conflicts of interest, and decision independence are checked in tables or separate registers. The wrong employee can be assigned to the job, and control evidence is difficult to restore later.
How the solution works
- Establishing performance-specific conditions of competence and quality
- Check the method, tool and human fitness
- Examining non-compliance and the results affected
- Perform the required review or separate certification solution
- Check the effectiveness of the corrective action and the applicable status of the document
Key challenges
- Competence and impartiality checks are carried out in a fragmented manner
- Method, equipment and calibration eligibility checked too late
- The certification decision does not relate to the applicable review and mandate
- Non-conformity and corrective action not linked to the whole process
Solution capabilities
Mandate and impartiality
Competence and conflict of interest are assessed for a specific task. The separation of roles is applied according to a real standard and scheme, rather than a single universal employee model.
Appropriateness of method and tool
Checking the required version, range, calibration and control information of the method. The valid date alone does not prove fitness for a specific measurement.
Effects of non-compliance
Inappropriate work or tool is linked to affected orders and already released results. The responsible specialist decides on stopping, repeating, informing or correcting the recipients.
Corrective action
A case-specific correction, consideration of the cause, and required process change are separated. Closing the task does not yet prove that the cause is no longer repeated.
Certification Decision
If an institution certifies, the assessment and review of a particular scheme is forwarded to the right solver. The issue, maintenance, renewal, suspension or cancellation is subject to the actual scheme.
History of the Review
The requirements and documents used are saved to the decision, complaint or appeal. If the non-compliance state is changed, the previous results remain in history.
Business context
- Competence and impartiality checks are carried out in a fragmented manner
- Employee credentials, methods competence, conflicts of interest, and decision independence are checked in tables or separate registers. The wrong employee can be assigned to the job, and control evidence is difficult to restore later.
- Method, equipment and calibration eligibility checked too late
- Versions of the methods, measurement limits, calibration validity, maintenance and equipment reservation are not linked to a specific work. A test may be performed by an improper or invalid instrument, and the work must be repeated.
- The certification decision does not relate to the applicable review and mandate
- The results of the scheme's evaluation, the required review and the right of the decider are not linked to a specific certification conclusion. It is difficult to justify the scope of the document issued and to restore whether the applicable conditions of the decision are met.
- Non-conformity and corrective action not linked to the whole process
- Incongruities in the client, sample, method, equipment or audit are recorded in separate tables and documents. Repeating the same causes, corrective actions are delayed, and their effectiveness is difficult to assess.
- The client receives an explainable evaluation decision
- The reliability of the service depends on the proper method, equipment, employee and required review. Linked checks allow to determine whether non-compliance affected the customer's result. In addition, the basis for the decision and validity of the document are visible in the certification activities, while retaining the responsibility of authorized professionals.
Core features
- Mandate and impartiality
- Appropriateness of method and tool
- Effects of non-compliance
- Corrective action
- Certification Decision
- History of the Review
Key integrations
- Registers of methods, equipment and competences
- Scope of eligibility, version applied, outcome of controls and history of use.
- Conduct of testing or evaluation work
- Affected orders, primary results and technical review conclusion.
- Certificate register, where applicable
- Authorised issue and subsequent change of status provided for by the scheme.
Potential impact (%)
The ranges indicate an illustrative relative change in the metric under the stated assumptions. Results depend on the starting position and actual use of the solution. Percentages for different metrics must not be added together.
Eligibility gap detected after performance
2–12%Decreasing
This illustrative scenario assumes that the controls described can address 10-30% of discrepancies. That share is assumed to fall by 20-40%. Company data is needed to verify both the addressable share and the resulting change.
Counting works that used a pre-determined wrong tool, method or authorization.
Incomplete Impact and Effectiveness Review
2–12%Decreasing
This illustrative scenario assumes that the controls described can address 10-30% of discrepancies. That share is assumed to fall by 20-40%. Company data is needed to verify both the addressable share and the resulting change.
Counting cases for which an agreed impact or efficacy review has not been completed by the deadline.
Conditional calculation scenarios. The assumptions have not been validated against client measurements.
When this solution is relevant
- Laboratory control data and non-conformities are reviewed separately from the results of specific tests.
- Once the problem is identified, it is difficult to assess which results that have already been issued need to be reviewed and whether the correction was effective.
Implementation requirements
For quality control, the requirements for review of the adequacy of the measures, staff credentials and results are described. Laboratories are compatible with the impact of non-conformities on previous results, and for certification, the relationship between evaluation, decision and document validity.
Further development options
- Additional schemes and controls only with their current requirements and separately revised mandates.