Top 10! ISO/IEC 17025:2005 and! ASCLD/LAB-International Supplemental 2011! Non-conformances!!!

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1 !! Top 10! ISO/IEC 17025:2005 and! ASCLD/LAB-International Supplemental 2011! Non-conformances!!!

2 op 10 Non-Conformances ISO/IEC 17025:2005 or the ASCLD/LAB- International Supplemental 2011! April 1, 2012 through March 31, 2013! 73 assessments!

3 Number 10!.9 - Assuring the quality of test and libration results!.9.2 Quality control data shall be analyzed and, where ey are found to be outside pre-defined criteria, planned tion shall be taken to correct the problem d to prevent incorrect results from being ported.!

4 Number 9! 3 Document Control! Document approval and issue! All documents issued to personnel shall be reviewed and approved.! Failure to control all management system documents! Often did not include internally generated forms or memos or external documents! Incomplete master list (or equivalent)!

5 Number 8! 2 Personnel! The laboratory shall have a documented ining program that shall be used to train the dividual in the knowledge, skills, and abilities eded to perform the testing. The laboratory s anagement system shall include procedures for raining and maintenance of skills and expertise.

6 Number 7! 10.3 Test Reports! When no definitive conclusions can be ached, the test report shall clearly communicate the ason(s).!

7 Equipment! Number 6! 5 Records shall be maintained of each item of equipment and ftware significant to the tests and/or calibrations performed. ecords shall include at least the following:! ) Identity of the item and its software! ) Manufacturer s name, type identification, and serial number! ) Checks that equipment complies with the specification! ) Current location, where appropriate! ) Manufacturer s instructions, if available, or reference to location! ) Dates, results and copies of reports and certificates of all calibrations, adjustments, acceptance criteria, and the due date of next calibration! ) Maintenance plan, where appropriate, and maintenance to date! ) Any damage, malfunction, modification or repair!

8 Number 5!.8 Handling of test and calibration items! The laboratory shall have procedures fo the transportation, receipt, handling, protection, storage, retention and/or disposal o test and/or calibration items, including all provisions necessary to protect the integrity of " "the test or calibration item, and to "" "protect the interests of the laboratory and " "th customer.!

9 Number 4!.4 Test and calibration methods and method alidation! General! Lacked written methods and procedures! Incomplete written methods and procedures! Deviations from methods not documented or authorized!

10 Number 3! 13 Control of Records! The lab shall retain records of original servations, derived data and sufficient formation to establish an audit trail,..! Not recording all original observations or data! Records insufficient to enable repeating under conditions as close as possible to the original! Personnel responsible for testing not identified! Original observations not maintained!

11 Number 2!.8 Handling of test and calibration items! laboratories shall be able to demonstrate at the evidence examined and reported on was that bmitted to the laboratory.! Chain of custody record receipt of evidence ALL internal transfers!. Signature, initials secure electronic equivalent at time of transfer! COC shall include date of receipt or transfer a description or unique ID of evidence! and and

12 Number 1!.10 Reporting the results!.10.1 General! The results of each test, calibration, or series of tests or calibrations.. shall be reported accurately, clearly, unambiguously and objectively, and in accordance with any specific instructions in the tes or calibration methods.!

13 Bonus! 4.2 Management System! The laboratory shall..! establish, implement, and maintain! Lack of implementation! communicated to, understood by, available to, and implemented by! Lack of staff understanding!

14 10! ! /4/11! 4/1/12-3/31 s! 4.2.1! 4.2.1! ! ! ! ! ! ! ! ! ! ! ! 5.4.1! 5.4.1! ! 5.8.1! ! 5.9.4! 5.5.5! 5.8.2! ! ! ! ! ! ! ! ! 5.9.4! ! 5.9.2!

15 SUMMARY! Many of the Top 10 are about procedures and/or records! Tips for success! Understand the difference between a document (e.g., policy, procedure, method, instructions) and a record Pay attention to the lists! Required items in a bulleted list! Required items in a sentence separated by commas!

16 SUMMARY! Remember that accreditation evaluates:! Conformance! Competence! Effectiveness!

17 ! Acknowledgements! American Society of Crime Laboratory Directors! Vendors! If you would like a copy of this presentation, please provide a business card, with TOP TEN written on the back, to any ASCLD/LAB staff member.!