The strategic analysis of an analysis

The strategic analysis of a chemical analysis in a laboratory consists of the following steps:

Step No 1. Define the analytical requirement of your customer. (The analyte, concentration, matrix, the measuring interval (range), the precision, the trueness, the ruggedness, the measurement uncertainty)

Step No 2. Choose the appropriate method, calibrated relevant equipment and competent personnel and establish traceability

Step No 3. Define the control limits, construct relevant Control Charts and establish the Internal Quality Control System

Step No 4. Develop and document the Standard Operating Procedure (SOP) how to run the method in your own laboratory

Step No 5. Choose the performance characteristics of your method, validate the method and document the validation report

Step No 6. Estimate the preliminary uncertainty based on the standard method or from Proficiency Testing (PT) data. 

Step No 7. Accredit your method as a new method or incorporate it in the flexible scope if appropriate.

Keep in mind that, under the ISO/IEC 17025:2017, the accreditation process consists of:
•The scope has been revised to cover testing, calibration and sampling.
•The process approach now matches that of newer standards such as ISO 9001.
•The standard has now a stronger focus on information technologies such as LIMS.
•More focus on risks regarding impartiality, confidentiality, decision making
•The laboratory shall participate in PTs
•The laboratory shall define its activity (Section 5.3).
•Reference materials and reagents are considered as equipment and an inventory is needed.
•Metrological traceability - notes moved to as non-mandatory. Annex A Demand on using RM from NMI (National Metrological Institute) or accredited laboratory when available.
•Simplified reporting is accepted after agreement with the customer.
•The standard covers data and reports both in paper and electronic format.

The following has been erased
•Assessment of the efficiency of training
•Job description not mandatory - a definition of competence requirement is needed

Step No 8. Your method is in use when the SOP is in use, the Internal QC is running and the validation report is in place.

Step No 9. Participate in PT schemes

Step No 10. Update your validation report and get a better estimate of s(r) and s(Rw), review the control limits and re-evaluate your control samples.

Step No 11. Estimate your uncertainty based on QC and validation data after a routine run of the method for at least 6 months.

Step No 12. Review the performance of your method to establish compliance with defined quality parameters and if it is still under control.