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#1: Modifications to Bika LIMS for ISO 17025 accredited labs

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Contents
Modificatons required for SANAS ISO 17025 acredited laboratory
Proposed by
Lemoene Smit
Proposal type
User interface, Functionality
Assigned to release
State
ready-for-merge

Motivation

Some customisation identified by SANAS review

Proposal

Version 1.1, A Sweetnam, 29 May 2006

Contents

1. Titration Volume
2. Titration Factor   
3. Analysed by   
4. Analysis Methods   
5. Analysis Units   
6. Analysis Request Remarks   
7. Additional text in published content   
8. Dates Received and Published   
9. Measure of Uncertainty   
10. New Groups   
11. Verified By   

1. Titration Volume

Titration volume must be captured for some of the analysis services.


a) Analysis service

In the Site set-up area, analysis service will have an additional check box to indicate whether the titration volume is required.

The default is ‘No’. An additional titration volume unit field, defaulted to ml

When an analysis service which requires titration volume has been selected, the titration volume appears on the analysis request and the job card


b) Analysis request

View and manage results will have an additional ‘Titration Volume’ column, if any of the services on that request require titration volume to be captured.

The column will not appear if none of the requested services require titration volume. The column will appear only to those members authorized to view job card information, i.e. members with a role of ‘manager’, ‘labmanager’, ‘labtechnician’ or ‘labclerk’.

For those analyses on the request which do not require titration volume, the column remains blank.

For analyses which require titration volume, an input text area is provided to capture the titration volume, and the submitted volume is displayed with its unit.

For those analyses which require titration volume, a value must be captured before the analysis is changed to to_be_verified status

c) Analysis request result email

The result email will reflect the titration volume and unit for those services which required it. The service name will be followed by ‘(Titr Vol) ’, and the result will be followed by the titration volume and unit in parentheses: e.g. 7 (5ml)

d) Job card – Analysis request in rows

Job card will display an additional ‘Titration Volume’ column, if any of the services on that job card require titration volume to be captured. The column will not appear if none of the requested services require titration volume.

For those analyses on the job card which do not require titration volume, the column remains blank. For analyses which require titration volume, an input text area is provided to capture the titration volume, and the submitted volume is displayed with its unit.

For those analyses which require titration volume, a value must be captured before the analysis is changed to to_be_verified status

e) Job card – Analysis request in columns

For each service which requires titration volume to be captured, the analysis name will indicate this as follows: Alcohol (Titr Vol) . The result column will be split into two columns, for result and titration volume.

The submitted volume is displayed with its unit.
For those analyses which require titration volume, a value must be captured before the analysis is changed to to_be_verified status

f) Query Analysis Requests

Query results will reflect the titration volume and unit for those services which required titration volume to be captured. The service name will be followed by ‘(Titr Vol) ’, and the result will be followed by the titration volume and unit in parentheses: e.g. 7 (5ml)

g) Query Analysis Requests email

The result email will reflect the titration volume and unit for those services which required it. The service name will be followed by ‘(Titr Vol) ’, and the result will be followed by the titration volume and unit in parentheses: e.g. 7 (5ml)

2. Titration Factor

Some analyses of a particular type on a job card, require a titration factor to be captured, once per job card. Since more than one service type may be on a job card, the titration factor is required for each of these service types.

Both job card views (AR by column or row) will show an additional table above the AR table, with two column: Analysis service and Titration Factor, and a row per analysis service type on the job card

3. Analysed by

The identity of the person who performed the analyses on a job card is to be captured.
For both job card views (AR by column or by row) a new field, ‘Analysed by’ will appear at the top of the job card The input is a drop down showing all lab personnel with a role of ‘LabManager’ or ‘LabTechnician’.

It will be necessary to make a selection before the analyses on the job card are moved into to_be_verified status

4. Analysis Method Descriptions

The analysis methods, captured in the analysis service description, will be displayed in a pop-up window linked to the analysis service name in
Analysis request create
Analysis request view, edit, manage results
Query Analysis request results
Analysis request results email
Query Analysis request results email

5. Analysis Units

Analysis units will be reflected on Analysis Request view, result emails, faxes and query result emails. The unit will be shown immediately after the result value

6. Analysis Request Remarks

Currently the remarks associated with an Analysis Request are only shown in the edit analysis request form. The remarks will be shown on the analysis request view; analysis request result email and fax

7. Additional text in published content

Results emails and faxes will include the following text:
Analysis remarks are not accredited
Analysis results are presented at a 95% confidence level

8. Dates Received and Published

Date Requested and Date Received are currently shown throughout the system for Analysis Requests. Date Requested will be removed from the data displayed (but not removed from the system) , and Date Published will be added to the data displayed. 

This change will be apparent in
Analysis Request lists (e.g. list of AR’s in ‘Sample Due’ status, etc.)
Analysis Request view
Job card view – AR in columns
Job card view – AR in rows
Analysis Request result email and fax
Analysis Request query results (Date Requested will remain as it forms part of the query constraints, and Date Published will be added)

9.  Measure of Uncertainty

An Analysis Service may have a table of uncertainty values associated with it. This will be captured in the analysis service definition area in site set-up, as a table of intercept minimum and maximum values, % confidence, error value.

Once a result has been submitted on an analysis service request, the result is used to look up the % confidence and error value on the analysis service, and these two new columns are displayed in
Analysis Request view
Analysis Request manage results
Analysis Request results email
Job card views
Query results view, email and fax

10. New Groups

Two new groups are to be defined:
Verifier – with verify role
Publisher – with publish role

Note: A lab may allow different personnel the authority to verify and publish results, it is necessary to create two new groups to separate these two functions currently shared by the ‘Reviewer’ role.

The 'to_be_verified' alert is also shown to members of the Verifier group, and to be published results, in the 'Verified' alert portlet

11. Verified By

The identity of the verifier must be displayed throughout the system. This field is populated at the time the AR is verified, with the identity of the logged on user.

The information will be added to the following forms:
Analysis Request view
Analysis Request results email and fax


 

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