Annual Management Review June Flowers, Flowers Chemical Labs Florida Society of Environmental Analysts - FSEA St. Petersburg, FL, May 2009

Why Report to Management? NELAC requirement To monitor the effectiveness of the Quality System To keep upper management in touch with lab operations Job security for QA staff

NELAC Requirement 2003 NELAC Standard On-Site Assessment Appendix A (Assessor Training) A.4.8 Quality Systems 3.b. Management Review Quality Systems 5.4 Management Requirements Management Reviews TNI Volume 1 (Lab) Module 2 (QS)

Management Reviews Periodically and at least annually, conduct a review of the labs quality system and testing activities to ensure their continuing suitability and effectiveness, and to introduce necessary changes or improvements.

Management Reviews The review shall take account of: Suitability of policies and procedures; Reports from managerial and supervisory personnel; Outcome of recent internal audits; Corrective and preventive actions; Assessments by external bodies;

Management Reviews continued Proficiency tests comparisons; Changes in volume and type of work; Client feedback; Complaints; Other relevant factors, such as QC activities, resources and staff training.

Suitability of Policies and Procedures; Are all procedures adequately documented? Has a change occurred in operations that require additional certification, SOP or policy change? Should any method/matrix/analyte be voluntarily relinquished from scope of accreditation?

Reports from Managerial and Supervisory Personnel Detail depends upon the size and structure of your lab Maintain file of incidents and include in annual report to management Project Management suggestions

Outcome of Recent Internal Audits Summarize status of findings or attach internal audit report SOPs that were reviewed & updated DOCs for each analyte/matrix-in particular the ones that there are no PTs for! Standards traceability Instrument maintenance and run logs

Corrective and Preventive Actions Summarize events that occurred throughout the year: Successful actions taken Outstanding issues and the new schedule for implementation Suggest improvements QC recovery range update

Assessments by External Bodies Summarize assessments performed State agencies, i.e., DEP, DOH Clients 3rd party Include any outstanding activities specific to each assessment

Proficiency Tests Comparisons Inter and Intra laboratory comparison by method, analyst, technology WS analyte performance vs. WP Follow-up corrective actions on any outliers 2 failures - get quick response- QUICK!

Changes in Volume and Type of Work Make observations and recommend options: Staff workload - cross training Instrument use QC frequency

Client Feedback Most important! Dont wait for the annual report to report good or bad news. Summarize rave reviews and how the topics were shared with staff. Discuss any lost clients and actions taken to get them back.

Complaints Must be documented ASAP! Avoid negative impact on staff. All mistakes can be made a lesson and something positive can come by improving on errors. Educate - re-train staff and clients.

Other factors, i.e., QC activities, Resources and Staff Training Summarize all employee training: Data integrity and ethics Workshops Cross training, DOC documentation LIMS updates Website review and update

Thank You! June Flowers Quality Systems Director Flowers Chemical Laboratories, Inc. Chair of TNI LASC Laboratory Accreditation Systems Program Committee