2.3.4. Management of documents and records

Documents are communicators of quality system. They cover three main components, i.e. the policies, the processes and the procedures. The policies are basically about 'what to do', processes tell us about 'how it happens' while procedures explain 'how to do it' [15]. These components are communicated through quality manuals, standard operating procedures, working instructions, external documents and job and personnel-related documents.

v. List of other related documents

g. Sample receipt record book

vi. List of standard operating procedures (SOP)

b. SOP for maintenance of heating block

d. SOP for maintenance of micropipette

f. SOP for preparation of IQC samples

c. SOP for maintenance of microplate reader

a. SOP for Urinary Iodine testing

e. SOP for method validation

vii. List of working instructions (WI)

b. WI for sample rejection c. WI for sample disposal

d. WI for glassware cleaning

b. Sample rejection forms

a. Sample receipt (Test request forms)

c. Instrument maintenance reports

i. Pre-analytical stage

ii. Analytical stage

a. Test worksheets

a. List of chemicals used for Urinary Iodine testing

c. Procedural flow chart for Urinary Iodine testing

d. Procedural steps for preparation of Urinary Iodine standards

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b. List of SOP, WI and external documents

e. Main list of Urinary Iodine quality records

f. Urinary Iodine standard preparation diagram

h. Record book for results release through telephone

a. WI for sample collection, storage and transportation

Herewith are the records we have in our Urinary Iodine laboratory:

d. Internal quality control value determination reports

On the other hand, records are information produced from the laboratory. Among all are forms, charts, test worksheets, patient records and reports, and quality control performance data [16].

Herewith are the documents we have in our Urinary Iodine laboratory:

	- a. Work norms for Urinary Iodine laboratory staff
	- b. Checklist for Urinary Iodine laboratory staff
	- c. Daily work list for Urinary Iodine laboratory staff
	- d. List for work order, responsibility and relationships for Urinary Iodine laboratory staff
	- e. Annual work target for Urinary Iodine laboratory staff
	- f. Job description for Urinary Iodine laboratory staff
	- g. Summary of job responsibilities for Urinary Iodine laboratory staff
	- a. Levey-Jennings chart for Low control
	- b. Levey-Jennings chart for Medium control
	- c. Levey-Jennings chart for High control
	- d. Worksheet for IQC ranges determination
	- a. Test request form
	- b. Sample rejection form
	- c. Test report form
	- d. Worksheet for Urinary Iodine testing
	- e. Non-conformance and corrective action form
	- a. Heating block maintenance record form
	- b. Microplate reader maintenance record form
	- c. Micropipette maintenance record form

v. List of other related documents

2.3.4. Management of documents and records

76 Quality Control in Laboratory

i. List of documents for laboratory personnel

ii. List of documents for internal quality control a. Levey-Jennings chart for Low control

iii. List of forms

a. Test request form

c. Test report form

b. Sample rejection form

b. Levey-Jennings chart for Medium control c. Levey-Jennings chart for High control d. Worksheet for IQC ranges determination

d. Worksheet for Urinary Iodine testing

iv. List of instrument maintenance record forms

a. Heating block maintenance record form

c. Micropipette maintenance record form

b. Microplate reader maintenance record form

e. Non-conformance and corrective action form

Documents are communicators of quality system. They cover three main components, i.e. the policies, the processes and the procedures. The policies are basically about 'what to do', processes tell us about 'how it happens' while procedures explain 'how to do it' [15]. These components are communicated through quality manuals, standard operating procedures,

On the other hand, records are information produced from the laboratory. Among all are forms, charts, test worksheets, patient records and reports, and quality control performance data [16].

d. List for work order, responsibility and relationships for Urinary Iodine laboratory staff

working instructions, external documents and job and personnel-related documents.

Herewith are the documents we have in our Urinary Iodine laboratory:

a. Work norms for Urinary Iodine laboratory staff b. Checklist for Urinary Iodine laboratory staff

c. Daily work list for Urinary Iodine laboratory staff

f. Job description for Urinary Iodine laboratory staff

e. Annual work target for Urinary Iodine laboratory staff

g. Summary of job responsibilities for Urinary Iodine laboratory staff

	- a. SOP for Urinary Iodine testing
	- b. SOP for maintenance of heating block
	- c. SOP for maintenance of microplate reader
	- d. SOP for maintenance of micropipette
	- e. SOP for method validation
	- f. SOP for preparation of IQC samples
	- a. WI for sample collection, storage and transportation
	- b. WI for sample rejection
	- c. WI for sample disposal
	- d. WI for glassware cleaning

Herewith are the records we have in our Urinary Iodine laboratory:

	- a. Sample receipt (Test request forms)
	- b. Sample rejection forms
	- c. Instrument maintenance reports
	- d. Internal quality control value determination reports
	- a. Test worksheets
	- a. Test reports
	- b. External quality assurance/proficiency testing reports
	- c. Non-conformance reports (NCR)
	- d. Management review meeting (MRM) minutes

In management review meeting, the performance of the laboratory is discussed. Source of problems is identified and corrective actions suggestions from staff are noted for further actions.

i. Analyze material for at least 20 runs

iii. Calculate the standard deviation (SD)

3.2. Procedural steps in IQC preparation

The records of the IQC concentration range determination ought to be kept and referred to every time after assay. The IQC values obtained in an assay are compared to the mean 2SD values. Then, the IQC plotter charts are drawn (Levey-Jennings chart). Example is as depicted in Figure 7. The results should be checked; if the IQC values are within the ranges, the respondents' results are considered acceptable and could be reported. If the IQC values are out of range, the respondents' results are unacceptable for reporting and analytical problems need to be identified and solved. Daily IQC performance is very important in laboratories. It is very crucial to use fresh IQC samples in every assay. The IQC samples should be treated the same as treating the

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1. Urinary iodine value of each respondent's urine sample is determined.

• Low pool (L): 30–90 μg/l (e.g. target to get mean around 60 μg/l)

• Medium pool (M): 110–130 μg/l (e.g. target to get mean around 120 μg/l)

4. The target values are achieved using mixture of L pool and H pool through formulas 1 and

5. Urinary iodine value of each modified urine pools is determined again and if the values are around the target values, the IQC pools are accepted as the new batch of IQC.

6. Urinary iodine values for each IQC are determined for at least 20 times (e.g. duplicates in

7. After outliers are omitted, mean, SD and range (mean 2SD) are calculated for each L, M and H pools and these ranges are used to determine the validity of test results.

8. Every time after thawing frozen pooled urine, it ought to be centrifuged for 1000 g for 15 minutes, supernatant is then taken and mixed well. Pipette aliquots of 250 μl in 500 μl

9. The IQCs in microcentrifuge tubes are thawed and are transferred into test tubes prior to assay, to be added with ammonium persulfate solution and ready for digestion with

• High pool (H): 200–300 μg/l (e.g. target to get mean around 250 μg/l)

2. Urinary samples with the value within the target range are pooled:

3. Urine iodine value of each urine pool is determined.

microcentrifuge tubes and keep at 20C until use.

blanks and respondent samples.

iv. Determine range (mean 2SD)

ii. Calculate the mean

respondent samples.

2 in Table 2:

10 different assays).
