L-A-B Newsletter March 2010
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Laboratory Accreditation Bureau's Accreditation Focus March 2010 Improving Laboratories through Accreditation Since 1999 . . . |
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In This Issue: |
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Feature Article / Non-Conformance Avoidance Have Confidence in the Integrity of your Data The foundation of any laboratories reputation is built on confidence in your laboratories ability to provide correct and reliable data. Data integrity is critical to the success of any laboratory. ISO/IEC 17025:2005 section 4.1.5 d) requires that your management system “have policies and procedures to avoid involvement in any activities that would diminish confidence in its competence, impartiality, judgment or operational integrity;” How can your laboratory effectively provide “confidence in its competence, impartiality, judgment or operational integrity of its operations”? This can be assured through the use of detailed policies, procedures and a program that specifically address these topics? Laboratories often state within their quality manual that they ensure the integrity of its operations but provide limited details for how this is assured. There may also be some kind of a confidentially / ethics agreement in place that personnel have signed once upon hire. Is this enough to assure that all employees fully understand and retain the importance of this topic and assure compliance?
Policy The laboratory should have a Policy in place addressing the laboratories exact position on Ethics, Integrity, and Code of Conduct. From this policy, procedures should be in place that defines exactly how the Policy will be implemented and assured. The laboratories policy may include its organizational mission and its relationship to the critical need for honesty and full disclosure in all aspects of laboratory operations including reporting of data. Detecting and deterring improper, unethical, or illegal actions begins with a zero-tolerance philosophy established by management.
Program An Ethics / Integrity program may also include written ethics agreements, examples of improper practices, examples of improper data manipulations, requirements for external ethics program training, and any external resources available to employees. Improper actions are intentional or unintentional deviations from contract-specified or method-specified analytical practices that have not been authorized. Unethical or illegal actions are the deliberate falsification of analytical or quality control results, where failed method or contractual requirements are made to appear acceptable. Ethics / Integrity program should: 1) Define improper and unethical, or illegal actions; 2) Outline elements of detection/deterrence programs for improper, unethical, or illegal actions; 3) Provide examples of improper laboratory practices; 4) Require the ethics policy to be read and signed by all personnel; 5) Have in place a “no-fault” reporting policy that encourages laboratory personnel to report suspected improper, unethical, or illegal activities, without fear of retribution; 6) Have in place a designated data integrity officer whom personnel may confidentially report suspected instances of improper, unethical, or illegal activities; 7) Require Initial and annual ethics training; 8) Be included as part of the Internal audit program; 9) Require an explanation and sign-off on all manual changes to data; 10) Where available in the instrument software, all electronic tracking and audit functions must be enabled; Ethics / Integrity program should prohibit: 1) Concealing a known problems; 2) Concealing a known improper or unethical behavior or action; 3) Failing to report the occurrence of a prohibited practice or known improper or unethical act to the appropriate laboratory or contract representative; 4) Misrepresenting or misreporting equipment quality control or verification data; 5) Fabrication, falsification, or misrepresentation of data; a. Creating data for a test that was not performed b. Creating information for a sample that was not collected c. Using external analysts, equipment, and/or laboratories to perform analyses when not allowed by contract 6) Improper clock setting (time traveling) or improper date/time recording; a. Resetting the internal clock on an instrument to make it appear that a sample b. Changing the actual time or recording a false time to make it appear that 7) Unwarranted manipulation of samples, software, or test conditions; a. Unwarranted manipulation of computer software b. Turning off, or otherwise disabling, electronic instrument audit/tracking functions
Implementation Detecting and deterring improper, unethical, or illegal actions begins with a zero-tolerance philosophy established by management. Improper, unethical, or illegal actions are detected through the implementation of surveillance protocols. To assure effective implementation of the laboratories Ethics / Integrity policy and program, Top Management must acknowledge their support by upholding the spirit and intent of the organization’s Ethics and Integrity procedures and effectively implementing the specific requirements. Employees must understand that any infractions of the laboratory data integrity procedures will result in a detailed investigation that could lead to very serious consequences including immediate termination, debarment or civil/criminal prosecution.
Training / Effectiveness A laboratory should provide Ethics / Integrity training as a formal part of new employee orientation and should also be provided on an annual basis for all current employees. Topics covered should be documented in writing and provided to all trainees. Training should include discussion regarding all Ethics / Integrity procedures and documentation. The initial Ethics / Integrity training and annual refresher training should have a signature attendance sheet or other form of documentation that demonstrates all staff have participated and understand their obligations related to Ethics / Integrity program. Data integrity training should require emphasis on the importance of proper written narration on the part of lab personnel with respect to those cases where data may be useful and provide specific examples of breaches of ethical behavior. Congratulations! - Newly Accredited L-A-B labs Accutest Laboratories Northern California Upcoming Public Trainings ISO 17025 Internal Auditor Trainings: June 15, 16 & 17th – Cleveland OH - *Venue to be announced by end of March! We just created this training based on recent demand in that area. DoD QSM 4.1 Training - The First Ever! May 12 & 13 – Indianapolis,IN Specific Event information to be forthcoming in the next week! Class size and seating is limited, first come first serve - for early notification reply to this email and request priority notification ! Our list of requests for priority notification is growing - do not hesitate - we expect this class to completely sell out by mid April! Upcoming Events & Conferences QMC March, 22-26,2010 Orlando, FL http://www.qualitymagconference.com/ MSC March, 22-26, 2010 Pasadena, CA EDQW - 2010 Environmental Monitoring & Data Quality (EMDQ) Workshop
Productivity Tips We've been talking about some “Time Management” tips from David Allen’s productivity classic “Getting Things Done”. Brief Recap: We are all witnessing and part of the unfolding of the “information age”. It’s everywhere, it’s un-avoidable. Never before in human history have we been bombarded with so many forms of communication. Fax, Phone, Email, Postal mail, co-workers, management all create “inflows” (ideas, “to-do’s”, information, recommendation, resources we may or may not need to act on, whether now or later). In broad categories there are really (3) things that can be done when we receive another ‘inflow’- 1) DO IT NOW 2) DELEGATE IT IMMEDIATELY 3) DEFER IT TIL LATER (schedule a date and time now on your calendar to take action on it) The Challenge / helpful hint presented was to practice ‘one touch’ management . . . instead of piling things on your desk corner – choose one of the (3) choices above. You’ll find that some things are “un-actionable” - you can’t “do it now” there is nothing to “delegate” and it’s not something you can “defer or schedule to act on” (at least not yet). Part of the theory here is that stress comes from the clutter, the stacks or piles. Relief (and sanity) comes from bringing “closure” to these “inflows” as quickly as possible. Create a folder for “un-actionable” items, this way you can clear your mind (and your desk) and put this in a place you can go to later to review if and when you have time. One touch management, add your ”Someday-Maybe Folder” get things off your desk and organized in some fashion – it’s a constant battle living in the information age – these tools can help! Hopefully, if you are working with these techniques you'll begin to get organized. . .then you'll slip away from them. It's OK, progress often comes from two steps forward and one step backwards. Mastery is not knowing every technique, it's becoming 'unconsciously competent' at a few core techniques. This applies to your time management skills as well. Manage your priorities - if you're organized fewer emergencies should arise. You can execute rather than react. If other impose emergencies on you - help them understand the benefits of becoming organized, of executing a plan - share these ideas with them. A couple favorite truths: "Failure to Plan = Planning to Fail" & "Your failure to plan does not constitute an emergency for me". There is no such thing as standing still, information moves at such a pace today you're either moving ahead, or it's passing you by - standing still is simply an illusion, a lie you tell yourself. |
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