Documents and records
Documents include policies, procedures, and work instructions for all aspects of the testing service and its QMS.
These documents should be approved before use, reviewed and revised regularly, and removed from circulation when obsolete. National reference laboratories, in collaboration with national programs and the support QA officer(s), should assist testing sites in developing site-specific SOPs and job aids for testing providers.
Records are generated from all activities, information, or results from performing testing. Records must be secured, maintained, and readily retrievable for use when needed.
Archiving duration is specific to each document and each record. It should be decided at the central level and each testing site should have the necessary information to organize the archiving system.
QMS Document and records required at testing site level
The following documents and records – which should be adapted to local requirements – should be implemented and used at the testing sites to ensure the management of testing sites' data and information:
Document / record name | Purpose | Person in charge, where and minimum frequencies |
1. SOP | Describe the testing procedures to be performed step by step | To review once a year by the QA officer/site supervisor to ensure alignment with procedures used. |
2. Job aids | A visual short version of the SOPs | To review once a year by the QA officer/site supervisor to ensure alignment with procedures used. |
3. Testing registers/ logbooks | Collect routine testing data which are going to be used for different purposes. Testing sites should ensure the confidentiality of the client's information. | In the testing site:
|
4. Test request, result forms | To implement a standardized form to order tests and provide result | In the testing site: should be filled by the testing provider and person in charge of consultation. |
5. Data reporting and analysis forms | Summarize key performance indicators to be reviewed, analyzed, and use to drive quality of testing improvement and transfer to management line | In the testing site:
|
6. EQC form
| To record the EQC events results and any corrective actions | In the testing site:
|
7. Non-conformances and complaint records with action taken | To record and review any non-conformance occurrence and the action taken | In the testing site:
|
8. Stock management records: stock cards, inventory forms, temperature monitoring log | To continuously monitor the availability of all necessary commodities and storage conditions. To calculate monthly consumption and ordering planning. | In the testing site:
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9. PMS testing provider feedback forms | To record and report any concern with quality and/or safety of an IVDs (RDTs). | To be filled by the testing provider with the support of the site supervisor and to send to the manufacturer when concerns occur |
10. Staff training record | To record training received and “authorization to perform testing” documents. | In the testing site, the person in charge |
11. Supervision visit report | To record and review supervision visit report to ensure ongoing monitoring of the testing site performance. | During supervision visit: QA officer provides the visit report and refers to it the following visit |
12. Patient referral forms | To refer client for treatment, prevention services or further evaluation. | The testing provider or CHW after testing according to the national referral process and in collaboration with other responsible people |