1.0 PURPOSE:
To design a Standard Operating Procedure that describes the archiving of raw materials, test samples, products and documents received from internal and external sources generated at laboratory.
2.0 SCOPE:
This SOP shall be applicable to Archive officer and respective Head of departments at laboratory.
3.0 RESPONSIBILITY:
Archiving officer, respective HOD’s of laboratory shall be responsible for the archiving of samples, raw materials, raw datasheets, test reports, files, records and all other concerned documents.
4.0 DISTRIBUTION
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4.1 The quality assurance department responsible to keep all SOPs ‘Master Copy’ approved through Quality Manager.
4.2 The copy of ‘Control Copy’ of all SOPs are being distributed in all user departments and placed near related Equipment/ Instrument.
5. 0 DEFINITIONS &ABBREVIATIONS :
5. 1 ABBREVIATIONS :
SOP: Standard operating procedure
HOD: Head of department
5.2 DEFINITIONS:
ARCHIVE: Archive contains documents that have accumulated over the course of an individual
Or organization lifetime and are kept to show the function of that person and organization.
QUALITY ASSURANCE: Quality assurance is a way of preventing mistakes or defects in manufactured products and avoiding problems when delivering solutions or services to customers which ISO 9000 defines as a part of quality management focused on providing confidence that quality requirement will be fulfilled.
6.0 PROCEDURE
6.1 The samples received shall be triplicate as SA, SB, and SC and one part SA shall be in the archive with a copy of DTRF with proper documentation in the entry record book ARC/S/LB/02.
6.2 If it is not finished product it shall be sealed properly for storage.
6.3 While submitting the samples to archive a copy of DTRF as per (SOP/QAU/004) shall be submitted which shall be maintained in the archive submission file ARC/FL/01 storage shall be valid for 2 yrs.
6.4 If there will be requirement of samples after submitting it in archive then the head of department shall have to fill a form named as material retrieve form which shall be maintained in ARC/FL/02.
6.5 All the documents related to archiving shall be maintained in the record log book ARC/D/LB/01.
7.0 PRECAUTIONS
7.1 While receiving test sample the sample officer should be careful regarding the condition of the samples whether the sample is in proper condition or not.eg. Moisture content, open sample Remove all the information from the sample before disposing it.
7.2 While storing the sample it should be easily accessible when it is required and stored according to its nature to keep it safe from deterioration Overwriting with random digital code enough times should be done
8.0 REFERENCES & FORMATS :
8.1 REFERENCES:
In house
8.2 FORMATS
8.2.1 Format-I: Format for Document History Sheet
8.2.2 Format-II: Material Retrieval Form
9 REVISION HISTORY
9.1 Maintain the history of SOP or document as per the format given in per SOP. It shall be maintained along with the current version of the SOP.
END OF THE DOCUMENT
You may like to read these links:
1. List of All SOPs and Documents for the Chemistry Laboratory
2. List of All SOPs and Documents for Quality Control
3. List of All SOPs and Documents For Quality Assurance Dept.
4. List of SOPs and Documents Required to Achieve NABL Accreditation
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