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 ......
3.0 SCOPE:
This SOP shall be applicable to the Archive officer and respective Head of departments at ......
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4.0 RESPONSIBILITY:
Archiving officer, respective HODs of ...... shall be responsible for the archiving of samples, raw materials, raw data sheets, test reports, files, records, and all other concerned documents.
5.0 DISTRIBUTION
5.1 The quality assurance department is responsible to keep all SOPs ‘Master Copy’ approved through the Quality Manager.
5.2 The copy of the ‘Control Copy’ of all SOPs is being distributed in all user departments and placed near related Equipment/Instruments.
6. 0 DEFINITIONS &ABBREVIATIONS :
6. 1 ABBREVIATION:
SOP: Standard operating procedure
HOD: Head of the department
6.2 DEFINITIONS:
6.2.2 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.
6.2.3 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 requirements will be fulfilled.
7.0 PROCEDURE
7.1 The samples received shall be triplicate as 1st, 2nd, and 3rd and one part 1st shall be in the archive with a copy of ...... with proper documentation in the entry record book ..............
7.2 If it is not the finished product it shall be sealed properly for storage.
7.3 While submitting the samples to the archive a copy of ...... as per (SOP/......./004) shall be submitted which shall be maintained in the archive submission file ....... storage shall be valid for 2 yrs.
7.4 If there will be a requirement for samples after submitting them in the archive then the head of the department shall have to fill a form named material to retrieve form which shall be maintained in ........
7.5 All the documents related to archiving shall be maintained in the record logbook .................
8.0 PRECAUTIONS
8.1 While receiving the test samples the sampling officer should be careful regarding the condition of the samples whether the sample is in the proper condition or not. eg. Moisture content, open sample Remove all the information from the sample before disposing of it.
8.2 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
9.0 REFERENCES:
In house
9.0 FORMATS
9.1.1 Format-I: Format for Document History Sheet
9.1.2 Format-II: Material Retrieval Form
10 REVISION HISTORY
10.1 Maintain the history of SOP or document as per the format given in Format-I. It shall be maintained along with the current version of the SOP.
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