1.1 To define the procedure for a Contract with an Outside Laboratory for Analysis in the Quality Control Department.
2.0 SCOPE
3.1 This standard operating procedure provides the procedure for Contract with Outside
Laboratory for analysis in the Quality Control Department at ………….
3.0 RESPONSIBILITY
3.1 Quality Control Person shall be responsible for:
3.1.1 To initiate and preparation of standard operating procedures.
3.1.2 Training and Monitoring of Standard Operating Procedure.
3.2 Head Quality Control shall be responsible for:
3.2.1 To confirm the content, correctness, and detailing of standard operating procedure.
3.2.2 To ensure the training of this standard operating procedure to all concerned department persons.
3.2.3 To ensure the implementation of the standard operating procedure after training.
3.3 Quality Assurance person shall be responsible for :
3.3.1 To check the standard operating procedure.
3.4 Head Quality Assurance shall be responsible for:
3.4.1 To approve new or revised standard operating procedures.
3.4.2 To ensure the implementation of the defined system.
4.0 DISTRIBUTION
4.1 Quality Control
5.0 DEFINITION & ABBREVIATION(S)
5.1 Definitions:
5.1.1 Contract analysis: This procedure provides a system to handle for approval of the contract with the outside laboratory for analysis of the samples
5.2 Abbreviations:
5.2.1 SOP : Standard Operating Procedure
5.2.2 QA : Quality Assurance
5.2.3 QC : Quality Control
5.2.4 QCD : Quality Control Department
6.0 PROCEDURE
6.1 Head Quality Control shall identify the laboratory that needs to be evaluated for contract analysis of the samples. The laboratory can be visited directly after giving the intimation or after collecting the information as per the procedure given below.
6.2 Head QC shall send the contract laboratory evaluation questionnaire as specified in Format No.: ………. to the proposed laboratory.
6.3 The proposed contract laboratory shall fill out the questionnaire and shall enclose the relevant documents as desired in the questionnaire.
6.4 Head Quality Control shall receive the duly filled questionnaire along with the attachment and he/she shall evaluate the laboratory on the basis of the information provided by the proposed contract laboratory.
6.5 Head Quality Control shall forward the “Contract Laboratory Evaluation form” to Head Quality Assurance or his/her designee with comments, if any.
6.6 Head Quality Assurance or his/her designee shall evaluate the questionnaire and see if the site audit of the proposed contract laboratory is required or not.
6.7 If required the proposed contract laboratory audit shall be planned. The proposed contract laboratory audit shall be done by the Head of Quality Control Head Quality Assurance or their designee.
6.8 If a site audit is required, the Head QC or Head QA shall intimate the proposed contract laboratory in advance.
6.9 On the basis of the audit’s findings and/or Contract laboratory evaluation format, the Head QC & QA shall decide the approval or rejection of the proposed contract laboratory.
6.10 If the proposed contract laboratory qualifies for approval, then the Head QA or his designee shall prepare the contract between the company and the proposed contract analysis laboratory.
6.11 In the contract, the company shall be regarded as the contract giver and the proposed laboratory shall be regarded as the contract acceptor.
6.12 Contract shall be prepared on the Letter Head of the company in duplicate and it shall be signed by either Head QC or Head QA.
6.13 Both the copies of contract shall be forwarded to the representative of the contract acceptor.
6.14 The representative of the contract acceptor shall sign both the copies of the contract and one duly signed copy shall be returned to the contract giver.
6.15 The contract shall be valid for a period of two years from the date of sign of the contract. As soon as the validity of the contract is over Head QC and Head QA shall assess the performance of the laboratory on the basis of the services provided by the contract acceptor.
6.16 If the performance is satisfactory and up to the mark then the contract giver shall renew the contract by sending the copy of the contract again for signature to the contract acceptor or plan an audit for renewal.
6.17 If the performance of the contract acceptor is not up to the mark then again evaluation of the laboratory shall be done with the help of a questionnaire specified in Format No.: …………..
6.18 The obsolete copy of the contract shall be stamped with “Obsolete” and then it shall be stored in the documentation cell for the next two years.
6.19 An original copy of the contract shall be stored in the documentation cell of QA and a copy of the same shall be given to QC.
6.20 After the contract, the sample required for outside testing shall be sent directly to the testing laboratory or handed over to their representative with a testing request having complete information about the material as well as for testing.
6.21 Contract Laboratory shall be responsible for planning the required analysis as per requirement given on request on an early basis.
6.22 After completion of the analysis, the contract laboratory shall intimate the results via phone, or email.
6.23 Whenever required, the certificate of Analysis shall be sent by email for urgent reference.
6.24 The Original copy of the Certificate shall be dispatched with all supporting raw data by courier or the same shall be submitted by their representative.
7.0 REFERENCE(S) & FORMAT(S)
7.1 Reference:
7.1.1 In House
7.2 Formats :
7.2.1 Format I: Contract laboratory evaluation report
7.2.2 Format II: Contract for analysis
8.0 REVISION HISTORY
8.1 Refer to SOP for SOP Format:
END OF THE DOCUMENT
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