Information
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Document No.
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Audit Title
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Client / Site
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Conducted on
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Prepared by
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Location
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Personnel
Additional information:
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Date report:
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Date evaluation:
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Report evaluated with:
Audited methods number(s)
Used documents (including version number and version number)
4.3 / 5.4.1
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Which relevant documents are available?
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Are these periodically checked?
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Are they managed correctly?<br>How ?<br>
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Is the working instruction understandable?<br>
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Does the layout meet the standard (AH802P)?<br>
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Are any points of the SOP not clear or wrong?
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Is an instruction manual for the used equipment available and is it understandable?
4.6.2
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In what way are the used chemicals and or standards checked for suitbility (do they meet the set criteria / is there a significant influance on the end result)?
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How is this registered ?
4.9
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Have all the corrective measurements of the last audit been closed and effective?
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If not which points are still open / nor effectively improved?
5.2 and 5.5.3 (AH1401P and AH1402P, job descriptions)
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How has the training of staff been executed and in what way was checked if this was effective (knowledge test)?
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How is this managed for interns and / or hired staff?
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How is the authority to use equipment and execute tests managed (authority matrix)?
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What level is the knowledge of the analist, does the analist know the procedure and global background of the test (random check to evaluate effectiveness of training)?
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What additional education or training does the analist receive, is a training or education planning available?
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Have all the tasks and responsibilities been recorded in a job description?
5.3
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Do specific environmental conditions play a significant role in relation to the analytical results?
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If yes, are the conditions managed properly?
5.5.1
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Is sufficient equipment available to execute the average number of tests? Give a short description
5.5.4, 5.5.5, 5.5.6 (AH803P)
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Does all critical equipment have a label (identification number)?
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Is all critical equipment registered in the QHSE equipment list?
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Does the logbook contain the correct information?
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If not properly maintained, what is missing?
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How is equipment service managed to prevent decline in performance, and is this recorded?<br>
5.5.2 (AH806W and AH823P)
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When was the equipment last calibrated and where is this recorded?
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Does the equipment meet the accuracy requirements?
5.5.10 (SOP / logbook)
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Is an in between measurement check necessary to check the calibration and how is this recorded?
5.5.11 (SOP)
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Is a procedure available which describes possible necessary corrections for the calibrations availabe, is this recorded (documentation)?
5.5.12 (SOP / logbook)
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Does all equipement and software have measures in place to prevent unintended changes that would discard the calibration validity and how is this managed?
5.6 (QHSE manual 5.6.2.1 and 5.6.2.2, AH812W, AH815W, AH813P and AH806W)
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How is traceability of measurement managed (the treacebility to SI units, can be ignored if the influance on the measurement uncertainty is not significant)?
5.5.7 (AH803P)
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How is equipment taken out of use when it is broken or does not meet the criteria?
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Is the influence of the defect on former results checked and is this recorded (where)?
5.5.9 (AH803P, AH823P)
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If equipment was put out of order and taken back into production, which checks where done to make sure it works properly and how is this recorded?
5.4.2 en 5.4.4 (RvA-T001 and AH823P)
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What is the claim of conformity and is this displayed in a correct way in the report, accreditation scope and relevant documentation?
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Is validation executed accordingly and correct?
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Is the method executed conform the claim made ?
5.4.5 (AH823P)
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When has the last Periodic Validation or Periodic Performance check been executed, was this within the planning?
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Do the results meet the criteria?
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Where have the initial performance charecteristics been recorded (initial validation) and do these meet the (external) demands?
5.7.1 (SOP)
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Which sample preparation has the sample had and does this meet the related demands (standard and / or legislation)?
5.4.6 (AH816W)
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Is the measurement uncertainty been calculated and recorded?
5.4.7
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Is the administration of data managed in Nautilus?
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If yes, is it validated?
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Where not, which parts are not recorded in Nautilus and how are these results checked?
5.9.1 (AH815W and NEN6603)
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How is the Quality Control managed and does this meet the criteria?
5.9.1b (AH812P)
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In what PT testing or second line controls was participated?
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Is it in accordance with any applicable external demands?
5.9.2 (AH825P)
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Have corrective measures been initiated where results did not meet the criteria of QC, did it solve the problem?
5.7.3
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If sample taking is part of the method, has a procedure been set up for this?
5.8.1 / 5.8.4 (AH107P and SIKB3001)
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Have samples been processed and stored before they are analysed?
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How are samples being protected against decline?
5.8.2
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Have samples been identified (sample number or barcode) during the analyses?
5.8.3
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If the fitness for use of the sample is doubted, what action has been taken?
4.13.1 and 4.13.2 (AH1501P)
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How and where are registrations stored?
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If digital back up of data is used, does this meet the procedural criteria (AH1501P)?
4.13.2.2
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Have observations been recorded at the moment of occurance?
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Are these traceable to the task (do a random check)?
4.13.2.3
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How are changes in registrations managed?
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Are all the original registrations of observations readable?
Non Conformances (refer to paragraph of the standard)
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NC1
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NC2
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NC3
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NC4
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NC5
Points for Improvement (refer to paragraph of the standard)
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PI1
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PI2
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PI3
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PI4
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PI5
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PI6
