SOP for Control of Stamps in Quality Assurance Department
Objective : To lay down a procedure for Control of Stamps in Quality Assurance department.
Scope : This standard operating procedure is applicable to formulation plant.
Responsibility :
Officer/Executive QA shall be responsible for implementation of procedure as per this SOP.
Head QA/ designee shall be responsible for compliance of this SOP.
Abbreviations and Definitions
Documents : Controlled Quality documents not limited to TDs, SOPs, Specifications & STPs/ GTPs, Protocols, etc.
Master Copy : The original set of controlled documents or written procedures which shall be retained at Documentation Cell of Quality Assurance and carry the stamp ‘MASTER COPY’.
Controlled Copy : The photocopy of the master copy of controlled documents (like SOPs, STPs, GTPs etc.) or written procedures which shall be distributed to the user department(s) as a part of document distribution procedure and shall bear a stamp as ‘Controlled Copy No.____’ and initials of the concerned personnel. These documents are controlled documents and are retrievable whenever superseded.
Uncontrolled Copy : The photocopy of master copy of controlled documents or written procedures which shall be given to any department or person for reference purpose only. These documents are not controlled documents; hence are non retrievable.
Procedure :
QA Personnel shall be responsible for control of stamps used in Quality Assurance department.
Order of stamps shall be send through e-mail, fax, written document to Administration department after approval of Head-QA.
Quantity of stamps received in QA shall be properly maintained with Stamp number on it.
All the stamps shall be numbered as 01, 02, 03 and so on as per the quantity available in department for e.g. if 3 Master copy stamps are available then numbering for all stamps shall be done like Master copy No-01, Master copy no-02 , Master copy no-03.
In case of any mistake in stamp, same shall be send back to supplier after putting remark for correction.
Colours and usage of stamps shall be finalized as per the respective SOPs.
The reference of Master copy, controlled copy, uncontrolled copy, obsolete copy, reference copy, review stamps shall be taken as per SOP.
Issuance stamp shall be put on each format issued to concerned department and on each BMR issued to Production department as per SOP.
All the stamps shall be properly marked with the Name and Number to avoid any kind of inconvenience and for easy traceability.
All the stamps shall be kept under lock and key by QA Personnel after day activities is over.
All the stamps shall be properly kept in separate small polybags as per there type i.e. Master, controlled etc. and kept in separate drawer under lock and key.
At a time one stamp of each type shall be used as per requirement for daily documentation or stamping purpose and it shall be properly put in separate polybag after use and kept under lock and key to avoid any misuse of stamps.
Tentative reference of all stamps in QA department is mentioned.
QA Personnel shall counter check all the stamps received for any kind of mistake i.e. spelling mistake etc.
Stamps which can’t be used further shall be properly destroyed by QA Personnel by cutting rubber portion of stamp into small pieces to avoid any kind of misuse.
Issuance record of stamps shall be recorded and Stamps destruction record shall be recorded.