Quality control - mrmwr

Quality control

Food and Water Laboratories Center (FWLC)

The FWLC’s policies and procedures related to quality control/quality assurance are available in its Quality Manual. A separate QA depoartment is established to have proper implementation of QA/ QC plan The goal of the FWLC’s QA/QC Program is to guarantee the generation of precise and accurate analytical data. Quality assurance involves the planned and systematic actions necessary to provide confidence in each analytical result. The QA/QC Program has two components: Quality Assurance (QA) - the system used to verify that the entire analytical process is operating within acceptable limits and Quality Control (QC) - the mechanisms established to measure non-conforming method performance.

ANALYTICAL METHODS: Only standard or validated methods given by AOAC, APHA, AACC, EPA. In case any of these methods are adopted with modification then proper validation is being carried out. Any method which has been developed in house is properly validated before being used for analysis.

QA DOCUMENTATION

STANDARD OPERATING PROCEDURES (SOPS) - Each laboratory operation is is clearly described in standard operating procedures. These procedures are periodically reviewed for updates.
ANALYTICAL PROCEDURES (AP): All analytical procedures are properly documented and are available easily to concerned people on LIMS

ANALYTICAL RECORDS:

All analytical records are properly maintained as per the schedule

TRAINING - Tests are performed by trained staff members. Each staff member must meet performance criteria before performing a test. We understand the importance of training and management is keen to train all the staff in their field of specialization as well as general training in the fields of English language skills, Computer skills, Fire and safety training etc.

RELIABLE AND WELL-MAINTAINED EQUIPMENT - Each instrument is operated by trained staff members. Maintenance logbooks are kept for each instrument. The instruments are calibrated according to manufacturer’s guidelines and in accordance to the relevant SOPs and APs. Balances and other measuring devices are calibrated frequently as per the calibration schedule. All glass measuring items are class A category

TRACEABILITY -

Analytical standards used are traceable to certified reference materials. Internal reference materials are checked as far as is technically and economically practicable against traceable standards.

ANNUAL REVIEW OF QC RESULTS -

The results of proficiency testing and QC results are evaluated annually and quarterly for trends. A system of control charts is used to determine if the system is in a state of statistical control and examine the relative variability of repetitive data. Control charts are also used with reference materials and spiked samples to assess the accuracy of measurements.

INTERNAL QUALITY CONTROL PROGRAMME:

Please refere our QC Manual for detailed IQC plan. QC plan is different for different sections as per the requirement and the details are given in the information about each section.

QC SAMPLES:

Minimum 10 % of total samples analysed are QC SAMPLES the number and type of QC Samples analysed differs from section to section and also in same section it depends on type of analyses, concentration of analyte etc. Please refere individual section’s information for details. Typically used QC Samples are as given below

BLANKS -

A reagent blank is analyzed with every set of samples that are extracted or digested. This reagent blank includes any and all reagents that are used in the analytical process and is carried through the entire process, including extraction and filtering or digestion.

DUPLICATES -

At least ten percent of samples are analyzed in duplicate. The samples for replicate analysis are selected randomly. IQC is followed to check correctness of data.

STANDARD REFERENCE MATERIALS –

These are also reffered as QC Samples or QC standards. At least one standard reference material is analyzed with each set of samples. Samples run with a standard reference material that falls outside the acceptable range are reanalyzed, including digestion or extraction if necessary.

SPIKE SAMPLES -

Sample fortifications or spikes are used to verify accuracy of tests requiring extensive sample manipulation (such as acid digestion) or for non-standard sample types.

SAMPLE CHECK PROGRAMMES AND PERFORMANCE TEST -

The FWLC participates in a number of proficiency tests and sample checking programmes offered by well known agencies of repute like LGC UK ( QM UK and Aquacheck UK for food and water chemistry and microbiology), INCAP for fortified foods , IAEA (for trace residue organic analysis in sediments, biota, and trace residue metal analysis in sediments and biota , MAPEP (for radioactivity measurement and radionuclide analysis),and AACC (for grain and flour analysis).