Day 3 NABL Accreditation Document Record Control Dr
Day 3 NABL Accreditation Document & Record Control Dr. Bipin Patel
4. 3 Document Control
4. 3 Document Control • The laboratory – shall control documents required by the quality management system and – shall ensure that unintended use of any obsolete document is prevented.
4. 3 Document Control • NOTE: 1 Documents that should be considered for document control are those that may vary based on changes in versions or time.
4. 3 Document Control • Examples include – policy statements, – instructions for use, – flow charts, – procedures, – specifications, – forms, – calibration tables,
4. 3 Document Control – biological reference intervals and their origins, – charts, – posters, – notices, – memoranda, – software documentation, – drawings, plans, agreements, and – documents of external origin such as regulations, standards and text books from which examination procedures are taken.
4. 3 Document Control • NOTE: 2 Records contain information from a particular point in time stating results achieved or providing evidence of activities performed and are maintained according to the requirements given in 4. 13, Control of records.
4. 3 Document Control • The laboratory shall have a documented procedure to ensure that the following conditions are met – a : all documents, including those maintained in a computerized system, issued as part of the quality management system are reviewed and approved by authorized personnel before issue.
4. 3 Document Control – b: all documents are identified to include: a title; a unique identifier on each page; the date of the current edition and/or edition number; page number to total number of pages (e. g. “Page 1 of 5, ” “Page 2 of 5, ”); • authority for issue. • • • NOTE: ‘Edition’ is used to mean one of a number of printings issued at separate times that incorporates alterations and amendments. ‘Edition’ can be regarded as synonymous with ‘revision or version’.
4. 3 Document Control • c: current authorized editions and their distribution are identified by means of a list (e. g. document register, log or master index). • d: only current, authorized editions of applicable documents are available at points of use.
4. 3 Document Control • e: where a laboratory’s document control system allows for the amendment of documents by hand, pending the re-issue of documents, the procedures and authorities for such amendments are defined, amendments are clearly marked, initialled and dated, and a revised document is issued within a specified time period.
4. 3 Document Control • f: changes to documents are identified. • g: documents remain legible. • h: documents are periodically reviewed and updated at a frequency that ensures that they remain fit for purpose.
4. 3 Document Control • I: obsolete controlled documents are dated and marked as obsolete. • J: at least one copy of an obsolete controlled document is retained for a specified time period or in accordance with applicable specified requirements.
Document List Quality Manual Quality Policy Quality Objectives Management Requirement (Quality System) Processes • Technical Requirement Processes • •
Document List • Management Requirement (Quality System) Procedures • Technical Requirement Procedures including – – Test SOPs Work Instructions IFU / Kit Inserts Equipment User Manuals • Management Requirement (Quality System) Forms & Formats • Technical Requirement Forms & Formats • Management Requirement (Quality System) Records • Technical Requirement Records
Document List • External Reference Documents including – ISO 15189: 2012 standard – NABL Documents – Indian Laws & Regulations – Text Books & International/ National Guides • Flow charts, • Specifications, • Calibration tables,
Document List • Biological reference intervals and their origins, • Charts, • Posters, • Notices, • Memoranda, • Software documentation, • Drawings, plans, agreements
4. 13 Control of Records
4. 13 Control of Records • The laboratory shall have a documented procedure for identification, collection, indexing, access, storage, maintenance, amendment and safe disposal of quality and technical records. • Records shall be created concurrently with performance of each activity that affects the quality of the examination.
4. 13 Control of Records • NOTE: 1: Records can be in any form or type of medium providing they are readily accessible and protected from unauthorized alterations. • The date and, where relevant, the time of amendments to records shall be captured along with the identity of personnel making the amendments (see 5. 9. 3).
4. 13 Control of Records • The laboratory shall define the time period that various records pertaining to the quality management system, including preexamination, examination and postexamination processes, are to be retained. The length of time that records are retained may vary; however, reported results shall be retrievable for as long as medically relevant or as required by regulation.
4. 13 Control of Records • NOTE: 2: Legal liability concerns regarding certain types of procedures (e. g. histology examinations, genetic examinations, paediatric examinations) may require the retention of certain records for much longer periods than for other records. • Facilities shall provide a suitable environment for storage of records to prevent damage, deterioration, loss or unauthorized access (see 5. 2. 6).
4. 13 Control of Records • NOTE: 3: For some records, especially those stored electronically, the safest storage may be on secure media and an offsite location (see 5. 10. 3).
4. 13 Control of Records • Records shall include, at least, the following • All of these quality and technical records shall be available for laboratory management review (see 4. 15).
4. 13 Control of Records • a, supplier selection and performance, and changes to the approved supplier list; • b, staff qualifications, training and competency records; • c, request for examination; • d, records of receipt of samples in the laboratory; • e, information on reagents and materials used for examinations (e. g. lot documentation, certificates of supplies, package inserts);
4. 13 Control of Records • f, laboratory work books or work sheets; • g, instrument printouts and retained data and information; • h, examination results and reports; • i, instrument maintenance records, including internal and external calibration records; • j, calibration functions and conversion factors;
4. 13 Control of Records k, quality control records; l, incident records and action taken; m, accident records and action taken; n, risk management records; o, nonconformities identified and immediate or corrective action taken; • p, preventive action taken; • • •
4. 13 Control of Records • q, complaints and action taken; • r, records of internal and external audits; • s, interlaboratory comparisons of examination results; • t, records of quality improvement activities; • u, minutes of meetings that record decisions made about the laboratory’s quality management activities; • v, Records of management reviews.
Numbering Scheme for Documents
Numbering Scheme for Documents • Write Short name of your lab. For example for Green Cross Pathology Laboratory Diagnostic Center – Sola Road, short name may be “GCSOLA” or GCSGPL 1 or GCSGPL 2 etc… • Followed by One space. • Followed by Number of documents. Numbering can be done as follow: • For example GCXXXXX NNNN
Numbering Scheme for Documents • Level 1 Documents: – Quality Manual: 100 – Quality Policy: 101 – Quality Objectives: 102 • Example : – GCSOLA 100, – GCSOLA 101, – GCSOLA 102.
Numbering Scheme for Documents • Level 2 Documents: – Laboratory Process Manual : GCSOLA 1000 – Quality System Processes : GCSOLA 1001 – General Processes: GCSOLA 1002 – Pre-examination Processes: GCSOLA 1003 – Examination Processes: GCSOLA 1004 – Post Examination Processes: GCSOLA 1005
Numbering Scheme for Documents • Level 3 Documents: – Quality System Procedures Manual: GCSOLA 2000 • Quality System Procedures: GCSOLA 2001 onward – General Procedures Manual: GCSOLA 3000 • General Procedures: GCSOLA 3001 onward – H. R. Manual : GCSOLA 4000 • Personnel Procedures : GCSOLA 4001 onward
Numbering Scheme for Documents • Level 3 Documents: – Equipment Procedures: GCSOLA 5000 to 5099 • • Hematology Equipment Manuals: GCSOLA 5101 to 5199 Cl. Pathology Equipment Manuals: GCSOLA 5201 to 5299 Cl. Biochem Equipment Manuals: GCSOLA 5301 to 5499 Micro&Sero Equipment Manuals: GCSOLA 5501 to 5699 Histopatho Equipment Manuals: GCSOLA 5701 to 5799 Cytopatho Equipment Manuals: GCSOLA 5801 to 5899 Genetics Equipment Manuals: GCSOLA 5901 to 5999
Numbering Scheme for Documents • Level 3 Documents: – Pre-examination Procedure Manual / Primary Sample Collection Manual: GCSOLA 6000 • Pre-examination Procedures: GCSOLA 6001 onward
Numbering Scheme for Documents • Level 3 Documents: • Procedure for Examination: GCSOLA 7000 to GCSOLA 7099 – Hematology SOPs: GCSOLA 7101 onward – Cl. Pathology SOPs: GCSOLA 7201 onward – Cl. Biochemistry SOPs: GCSOLA 7301 to 7499 – Microbiology & Serology: GCSOLA 7501 to 7699 – Histopathology SOPs: GCSOLA 7701 onward – Cytopathology SOps: GCSOLA 7801 onward – Genetics & Mol Pathology SOPs: GCSOLA 7901 onward
Numbering Scheme for Documents • Level 3 Documents: • Kit Inserts: Same as SOP numbering with tag “/IFU” at the end of number. For example – – – – Hematology IFUs: GCSOLA 7101/IFU onward Cl. Pathology IFUs: GCSOLA 7201/IFU onward Cl. Biochemistry IFUs: GCSOLA 7301/IFU to 7499/IFU Microbiology & Serology: GCSOLA 7501/IFU to 7699/IFU Histopathology IFUs: GCSOLA 7701/IFU onward Cytopathology IFUs: GCSOLA 7801/IFU onward Genetics & Mol Pathology IFUs: GCSOLA 7901/IFU onward
Numbering Scheme for Documents • Level 3 Documents: – Quality Control Procedures : GCSOLA 8000 - 8099 • • Quality Control Procedure for HEM: GCSOLA 8101 Quality Control Procedure for CP: GCSOLA 8201 Quality Control Procedure for BIO: GCSOLA 8301 Quality Control Procedure for MICR: GCSOLA 8501 Quality Control Procedure for HIST: GCSOLA 8701 Quality Control Procedure for CYTO: GCSOLA 8801 Quality Control Procedure for GENE: GCSOLA 8901
Numbering Scheme for Documents • Level 3 Documents: – Post Examination Procedures: GCSOLA 9001 onward – Reporting of Result Procedures : GCSOLA 9101 onward – Release of Result Procedures : GCSOLA 9201 onward
Numbering Scheme for Documents • Level 3 Documents: – Laboratory Information Management Manual: GCSOLA 9300 • Laboratory Information Management Procedures: GCSOLA 9301 onward
Numbering Scheme for Documents • Level 3 Documents: – Laboratory Safety Manual: GCSOLA 9400 • Laboratory Safety Procedures: GCSOLA 9401 onward
Numbering Scheme for Documents • Level 3 Documents: • Test Work Instructions GCSOLA 17000 to GCSOLA 17999 – Hematology WIs: GCSOLA 17101 onward – Cl. Pathology WIs: GCSOLA 17201 onward – Cl. Biochemistry WIs: GCSOLA 17301 to 17499 – Microbiology & Serology: GCSOLA 17501 to 17699 – Histopathology WIs: GCSOLA 17701 onward – Cytopathology WIs: GCSOLA 17801 onward – Genetics & Mol Pathology WIs: GCSOLA 17901 onward
Numbering Scheme for Documents • Level 4 Documents - Forms & Formats: – Quality System Forms & Formats: GCSOLA 22000 onward – General Forms & Formats : GCSOLA 23000 onward – H. R. / Personnel Forms & Formats: GCSOLA 24000 onward
Numbering Scheme for Documents • Level 4 Documents - Forms & Formats: – Equipment & Reagent Forms & Formats : GCSOLA 25000 onward • • Hematology Equipment Manuals: GCSOLA 25101 to 25199 Cl. Pathology Equipment Manuals: GCSOLA 25201 to 25299 Cl. Biochem Equipment Manuals: GCSOLA 25301 to 25499 Micro&Sero Equipment Manuals: GCSOLA 25501 to 25699 Histopatho Equipment Manuals: GCSOLA 25701 to 25799 Cytopatho Equipment Manuals: GCSOLA 25801 to 25899 Genetics Equipment Manuals: GCSOLA 25901 to 25999
Numbering Scheme for Documents • Level 4 Documents - Forms & Formats: • Pre-examination Forms & Formats : GCSOLA 26000 onward
Numbering Scheme for Documents • Examination Forms & Formats : GCSOLA 27000 onward – Hematology F&F: GCSOLA 27101 onward – Cl. Pathology F&F: GCSOLA 27201 onward – Cl. Biochemistry F&F: GCSOLA 27301 to 27499 – Microbiology & Serology: GCSOLA 27501 to 27699 – Histopathology F&F: GCSOLA 27701 onward – Cytopathology F&F: GCSOLA 27801 onward – Genetics & Mol Pathology F&F: GCSOLA 27901 onward
Numbering Scheme for Documents • Quality Control Forms & Formats : GCSOLA 28000 onward – Hematology F&F: GCSOLA 28101 onward – Cl. Pathology F&F: GCSOLA 28201 onward – Cl. Biochemistry F&F: GCSOLA 28301 to 28499 – Microbiology & Serology: GCSOLA 28501 to 28699 – Histopathology F&F: GCSOLA 28701 onward – Cytopathology F&F: GCSOLA 28801 onward – Genetics & Mol Pathology F&F: GCSOLA 28901 onward
Numbering Scheme for Documents • Level 4 Documents - Forms & Formats: – Post-examination Forms & Formats : GCSOLA 29000 onward – Reporting of Results Forms & Formats : GCSOLA 29100 onward – Release of Result Forms & Formats : GCSOLA 29200 onward – Laboratory Information System Forms & Formats : GCSOLA 29300 onward – Laboratory Safety Forms & Formats : GCSOLA 29400 onward
Numbering Scheme for Documents • Level 4 Documents – Registers/ Files: • Write “File or Reg. No / Year” after GCXXXXX of F&F. Example: – Quality System Register/ Files: GCSOLA 22000 /01/19 – General Register/ Files : GCSOLA 23000 /01/19 – H. R. / Personnel Register/ Files: GCSOLA 24000 /01/19 – Equipment & Reagent Register/ Files : GCSOLA 25000 /01/19 – Pre-examination Register/ Files : GCSOLA 26000 /01/19
Numbering Scheme for Documents • Examination Register/ Files : GCSOLA 27000 /01/19 – Hematology R&F: GCSOLA 27101 /1/19 – Cl. Pathology R&F: GCSOLA 27201 /1/19 – Cl. Biochemistry R&F: GCSOLA 27301 /1/19 to 27499 /1/19 – Microbiology & Serology: GCSOLA 27501 / 1/19 to 27699 / 1/19 – Histopathology R&F: GCSOLA 27701 /1/19 – Cytopathology R&F: GCSOLA 27801 /1/19 – Genetics & Mol Pathology R&F: GCSOLA 27901 /1/19
Numbering Scheme for Documents • Quality Control Register/ Files : GCSOLA 28000 /01/19 – Hematology R&F: GCSOLA 28101 /1/19 – Cl. Pathology R&F: GCSOLA 28201 /1/19 – Cl. Biochemistry R&F: GCSOLA 28301 /1/19 to 28499 /1/19 – Microbiology & Serology: GCSOLA 28501 /1/19 to 28699 /1/19 – Histopathology R&F: GCSOLA 28701 /1/19 – Cytopathology R&F: GCSOLA 28801 /1/19 – Genetics & Mol Pathology R&F: GCSOLA 28901 /1/19
Numbering Scheme for Documents • Level 4 Documents - Register/ Files: – Post-examination Register/ Files : GCSOLA 29000 /01/19 – Reporting of Results Register/ Files : GCSOLA 29100 /01/19 – Release of Result Register/ Files : GCSOLA 29200 /01/19 – Laboratory Information System Register/ Files : GCSOLA 29300 /01/19 – Laboratory Safety Register/ Files : GCSOLA 29400 /01/19
Numbering Scheme for Documents • Level 5 Documents – External Reference Docs. – Quality System Ref. Doc. : GCSOLA 32000 onward – General Ref. Doc. : GCSOLA 33000 onward – H. R. / Personnel Ref. Doc. : GCSOLA 34000 onward – Equipment & Reagent Ref. Doc. : GCSOLA 35000 onward – Pre-examination Ref. Doc. : GCSOLA 36000 onward
Numbering Scheme for Documents • Level 5 Documents – External Reference Docs. – Hematology Ref. Doc. : GCSOLA 37101 onward – Cl. Pathology Ref. Doc. : GCSOLA 37201 onward – Cl. Biochemistry Ref. Doc. : GCSOLA 37301 to 37499 – Microbiology & Serology: GCSOLA 37501 to 37699 – Histopathology Ref. Doc. : GCSOLA 37701 onward – Cytopathology Ref. Doc. : GCSOLA 37801 onward – Genetics & Mol Pathology Ref. Doc. : GCSOLA 37901 onward
Numbering Scheme for Documents • Level 5 Documents – External Reference Docs. – Post-examination Ref. Doc. : GCSOLA 39000 onward – Reporting of Results Ref. Doc. : GCSOLA 39100 onward – Release of Result Ref. Doc. : GCSOLA 39200 onward – Laboratory Information System Ref. Doc. : GCSOLA 39300 onward – Laboratory Safety Ref. Doc. : GCSOLA 39400 onward
Numbering Scheme for Documents • Other Documents: like – Flow charts : GCSOLA 40000 to GCSOLA 49999, – Specifications: GCSOLA 50000 to GCSOLA 59999, – Calibration tables: GCSOLA 60000 to GCSOLA 69999, – Biological reference intervals and their origins: GCSOLA 70000 to GCSOLA 79999, – Charts: GCSOLA 80000 to GCSOLA 89999, – Posters: GCSOLA 90000 to GCSOLA 99999,
Numbering Scheme for Documents – Notices: GCSOLA 100000 to GCSOLA 109999, – Memoranda: GCSOLA 110000 to GCSOLA 119999, – Agreements: GCSOLA 12000 to GCSOLA 129999, – Software documentation: GCSOLA 130000 to GCSOLA 139999, – Drawings: GCSOLA 140000 to GCSOLA 149999, – Plans: GCSOLA 150000 to GCSOLA 159999 – Lists: GCSOLA 160000 to GCSOLA 169999
List of Procedures • Click Here
List of Records • Click Here
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