1. A Pareto Example

2. Deficiencies/gaps could be categorized as: Documents (write/revise, SOP, worksheets) Traceability Technical ( control charts, MU, validation) Equipment Personnel (training) Sample (storage, integrity)

3. Gap Assessment Summary (example) Item numberDeficiencyCategory 1The lab does not have written instructions for the preparation of feed control samples. 2Instrument printouts do not include traceability to the analyst performing the test. 3The lab has not estimated the measurement uncertainty for the analysis of minor elements in feed (SOP #123) 4The CEM Microwave was due for calibration July 31, 2015 but was still in use in October 2015. 5The lab does not have a training record for John Smith, who performed and reported the Determination of Protein in Feeds (SOP #456). 6Mold was observed growing in penalty sample 122-5, stored in the grinding room at ambient temperature. … … 38 Documents Traceability Technical Equipment Personnel Sample

4. Category Documents Traceability Technical Equipment Personnel Sample Total # of Findings % of Total FindingsCumulative % 12 9 6 5 4 2 34 25 15 12 10 4 34 59 74 86 96 100

6. Alternate categories for deficiencies:

7. Gap Assessment Summary (example) Item numberDeficiencyCategory 1 The lab does not have written instructions for the preparation of feed control samples. 2 Instrument printouts do not include traceability to the analyst performing the test. 3 The lab has not estimated the measurement uncertainty for the analysis of minor elements in feed (SOP #123) 4 The CEM Microwave was due for calibration July 31, 2015 but was still in use in October 2015. 5 The lab does not have a training record for John Smith, who performed and reported the Determination of Protein in Feeds (SOP #456). 6 Mold was observed growing in penalty sample 122-5, stored in the grinding room at ambient temperature. … … 35 Time-intensive Low hanging fruit Time-intensive Low hanging fruit Low cost Capital expense

8. CategoryTotal # of Findings% of Total FindingsCumulative % High cost512 Low expense61527 Time-intensive164370 Low hanging fruit1130100

10. Questions?