Quality
Quality management system
Primary tool used by lab to assist compliance with the QMS?
LIMS
WI applicable to Calibration?
WI0300
How can you demonstrate the training?
Training Evidence: training report, quiz in LIMS
Procedures revision types and describe them:
>Editorial changes
>Procedure Revision
Mention the differences between Not conforming test and not conforming results?
NCT: This may result in invalid test, the laboratory perform CMR correction per WI0101- documented on QCR.NCR: Test results that do not conform to the conformance requirements documented in the CMR shall have a Disposition Statement indicating lack of conformance.
For quality there are two types of documents:
1.-Documented information that is maintained (Procedures per WI0100) 2.-Documented information that is retained (Records per WI7300)
Whats is the Uncertainty
Non-negative parameter characterizing the dispersion of the quantity values being attributed to a measured
What should include a training report?
Type of training approach used, training material used, what was done and the results, restrictions limitations, additional comments
you want a revision for a procedure, what you do?
change request in LIMS
All labs had quality audits: Nadcap aproved labs and non Nadcap Labs, mention at least two of each one
Nadcap:Site quality audits; Periodic observation of test; Self audit; Network audit; Nadcap audit
Not Nadcap: Internal audits; Site quality audits
What you need to review in a CMR Results?
>CMR results are documented appropriately > transfer CMRs are completed.>result disposition appropriate for the Detailed Instructions and/or Conformance Requirements.>all SOP fields contain an appropriate and correct entry> CMR shall either be placed “on hold” for customer and external reviews or placed “in review” in accordance with Second Level Employee Review.>If the review of test results requires approval, as defined by CMR instructions or technical work instructions, the following statement shall be used: “I approve these test results”.
Mentions the differences between:Invalid Test; Replacement Test; Retest
•INVALID TEST: A test whose results are found to be unrepresentative based on identified causes other than the proprieties of the material being tested (e.g. errors in specimen machining or testing). When an invalid test is replaced, tests are recorded and cross referenced with the original tests, including explanations where applicable.
•REPLACEMENT TEST: a repeat of a test by the same laboratory, using the same method, equipment (of equivalent accuracy or better) and sample (same material, lot/heat, location, orientation as the original or on the original specimen if not destroyed). REPLACEMENT TESTS are performed in response to INVALID TEST.
•RETEST: A repeat of a TEST by the same laboratory, using the same method, equipment (of equivalent accuracy or better), and sample (same material, lot/heat, location, orientation as the original or on the original specimen if not destroyed). RETEST is performed in response to non-conforming test results and only when allowed by material or Honeywell specification, and are performed in accordance with the material or Honeywell specification
Which are the training Levels for a procedure?
Awareness, trained, certify, SME
What are the two types of procedures?
>Based in standard
>Based in Methods
Mention the WI applicable to Lab Quality
-WI0110: Quality Systems and Practices-WI8280: Quality System Compliance Program-WI0100: Work Instruction System-WI0101: CMR Work Flow Process-WI0300: Calibration of Equipment-WI0700: Equipment Maintenance-WI0106: Round Robin Testing-WI7300: Record Retention Schedule
Revision of released CMRS:
Edit CMRs, Activate Released CMRs
The laboratory uses a calibration schedule with frequencies in accordance with what?
Manufacturers’ recommendations or the individual checklist requirements for all internal and external calibrations performed on testing equipment. This schedule documents duration between calibrations (frequency) and responsibility for calibration (source).
Process owner
What are the lab procedures auditables and the non auditables?
Auditables: Internal Calibration instructions; Lab procedures;Test Methods
Non Auditables:Standar operation Sheets (SOS); Equipment information; Lab Guidelines
What to do when transcription errors are identified in a released CMR?
proceed to activate CMR and correct error and document actions per WI0101 Transcription error correction may result in an invalid test or changes in disposition, in this case a RPS (rapid problem solving) may be necessary to avoid reoccurrence, as well as customer notification.
What to do when LIMS is down? and where to find it?
WI 5501, what to do when LIMS is down procedure
Which are the procedure for all equipment calibration?
1.-Define, establish and document calibration requirements 2.-Request/ perform calibration 3.-Obtain/ create calibration certificate 4.-Equipment Labeling 5.-Out of Tolerance(IF applicable)
Who can perform a Round Robin or PT?
All the analysts certified in the process
where can i find the procedure for WI publication?
WI0100