1. 2016 MFRPS: Changes To Standard 10 Guy F. Delius, R. S. CSO Food and Drug Administration Office Of Partnerships Standards Implementation Staff February 3, 2016 8:00-8:45 am.

2. 2016 MFRPS Standard 10 MFRPS Standard 10: This Standard describes the elements of Laboratory Support for a Manufactured Food Regulatory Program. – Ensures there is a strong/appropriate support system for the regulatory program. – The Laboratory Support System meets minimum Laboratory professional standards to ensure analysis are available and help ensure integrity of results

3. Importance of Laboratories Properly accredited food laboratories are a major segment of the Integrated Food Safety System as envisioned by FDA leadership and FSMA. Thousands of food samples collected every year for illness, injury, complaint, surveillance and even death rest upon the capable hands of our Laboratories for analysis. Our laboratories analyze samples and report accurate findings relating to illness/injury and further, help prevent additional illnesses/injury

4. Laboratory Support and Credentials Laboratories must be properly staffed/managed with suitably trained staff using the proper equipment and systems to meet the growing regulatory, industry and consumer need of our Nations evolving food safety system. MFRPS Standard 10 addresses some of the Laboratory criteria and related credentials needed in order to fully support a State food safety regulatory program.

5. New Standard 10/MFRPS Overall Changes – Definitions Section: Primary servicing laboratory. Means any laboratory used by the State program for ongoing or routine testing. – Similar flow for each Standard – New universal numbering/sequencing system 10.1 – 10.3.1 » 10.3.1.4 – Clarifying language on requirements

6. New Standard 10: (10.2) Requirement The State program has access to the laboratory services needed to support program functions and documents its laboratory capabilities including agreements with external labs.

7. New Standard 10: (10.3.1.3) Elements Outlines what should be in a contract or written agreement with a primary servicing laboratory. – Can be a contract or written agreement, i.e. MOU, email, or any written format. Must define the responsibilities of each party Describe the types of testing services to be performed Describe how exceptions to planned work will be communicated

8. New Standard 10: (10.3.1.4) Elements Requires documentation from non-primary servicing laboratories. – There shall be documentation of the services provided; the documentation can be in a simplified format.

9. New Standard 10: (10.3.3.2) Elements Requires laboratory programs to have accreditation from ISO/IEC 17025:2005 (or current version) to analyze food and environmental samples. The accreditation body of the laboratory must be a full signatory to the International Laboratory Accreditation Cooperation (ILAC)-Mutual Recognition Arrangement (MRA). OR,

10. New Standard 10: (10.3.3.1-6) Elements Or, If the supporting laboratory does not hold such a credential, then the program must utilize laboratories that have in place a quality system which incorporates the following ISO management and technical principles. – Calibration and Maintenance – Analyses are performed using validated and verified test procedures – Documentation of sample traceability

11. New Standard 10: (10.3.3.1-6) Elements Continued: – Documentation of analytical results and analysts performing work; – Analysts that are trained and authorized to perform technical procedures; and – Periodic audits AND

12. New Standard 10: (10.3.3.2-6) Elements (2) A documented process that defines the activities necessary to take corrective action when non-conforming work occurs. (3) A document control procedure that assures appropriateness of documents. (4) A documented record keeping process. (5) A documented process to assure reference materials and cultures are fit for purpose. (6) A documented process to assure the lab participates in proficiency testing

13. New Standard 10: ( 10.5) Documentation 10.5.1 Appendix 10 (which has been updated to reflect/mirror the Standard). 10.5.2 Contracts or written agreements with Primary Servicing Laboratories 10.5.3 A list of labs used by the state that are non-primary servicing 10.5.4 Documentation of services provided by primary servicing laboratories 10.5.5 ISO Accredited Lab, certificate of scope of accreditation

14. New Standard 10: (10.5) Documentation Continued: 10.5.6 Non-ISO Accredited Lab Documents – Quality Manual – Corrective Action – Document Control – Record Keeping – Process for References – Process for Proficiency Testing Activities

15. New Standard 10: No overwhelming changes Updated flow and numbering sequences Updated to clarify requirements needed for ISO and non-ISO laboratories and documentation needed to verify status. MFRPS Standard 10 Continues to showcase the importance and necessity of laboratories in the overall IFSS.

16. Contact Information Guy F. Delius, R.S. CSO FDA Office of Partnerships-Standards Implementation Staff Guy.Delius@fda.hhs.gov