Adapting a Quality Management System to Meet Changing Requirements

1. Adapting a Quality Management System to Meet Changing Requirements Zachary Willenberg Battelle Memorial Institute Columbus, OH

2. Experience Work in the Environmental Market group Been in the quality field for 8 years Have developed or been part of a team developing multiple quality systems for various programs and agencies.

3. Quality Management Systems • A necessity in today’s market • Contractually required • Have defined requirements • EPA Q and R Documents • ISO • GLPs • UFP

4. Contract Research Organizations • For private industry, can have multiple funding sources • Each funding source may have separate requirements or specifics needs • Need a QMS that is comprehensive but allows flexibility

5. Quality Requirements • EPA • EPA Order 5360 • EPA R and G Documents • ISO • 9000, 14000, 17000 Series • Very document heavy • GLP • QA and document heavy • Requires validation of hardware and software systems and SOPs to define work practices • UFP • Relates to both EPA and ISO requirements, with some minor differences

6. QMS Case Study • Example QMS has been in use for almost 10 yrs • Based on requirements from ANSI E4 • QMP defines system • Used on multiple programs for US EPA, USACE, US Army, and other organizations • Core properties of the system have not changed, but the functionality has been adapted

7. Case Study 1 Dioxin/Furan Analysis Laboratory has specific certification Requires much higher level of quality than remaining group Did not want to impose higher level on projects or non-affected staff

8. Results Decided to have group-specific SOPs Included in this were specific QA oversight SOPs Tailored training of staff to meet higher needs

9. Case Study 2 Analysis lab is “Approved” for specific a specific set of analyses for a military agency Lab was assessed against ISO 17025 Level of work did not warrant project specific QMP

10. Results Again, utilized aspect of having Group SOPs Specific training was developed just for affected staff Decided to develop project-level QAPP as way to set QA requirements Decided some aspects were important enough to put into next revision of the QMP

11. Case Study 3 EPA Program approves of existing QMP, but has specific documentation requirements beyond standard ANSI E4 and EPA R and G documents

12. Results Existing QMP has option for Addendas Decision to make Program-Specific Addendum Addendum only addressed items beyond requirements in existing QMP Got Agency buy-in and approval on Addendum

13. Case Study 4 Perform occasional GLP work for EPA or other organizations EPA R and G not as stringent as GLP Do not want higher level of QA to affect other projects or non-affected staff

14. Results Much like the Dioxin/Furan lab, utilized specific groups Decide in group affected that having SOPs compliant with GLPs were good for normal business QMP allows for project documents to define quality practices needed

15. Conclusion QMS are essential, especially for contract laboratories Designing the system to be flexible allows for a broader range of work without extra oversight Use of tools like QMP Addendums helps give that flexibility

16. Questions?Zachary WillenbergBattelle Memorial InstituteColumbus, OH