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PEPFAR Quality Control and Method Validation Activity 4 Handout: Westgard Rules

This PDF contains westgard rules for activity 4 scenarios.

Traditional "Westgard Rules" Date: Control Data Tech: 12s No In-Control one point out Report Data of 2 SD Ye s No 13s 22s R 4s 41s 10x No No No 4 CONSECUTIVE No one point (across runs) The range control values on 10 CONSECUTIVE outside 3 SD 2 CONSECUTIVE (difference) between one side of the values on ONE values outside the two controls within a mean and further side of the mean. same 2 SD run exceeds 4 SD s. than 1SD from the mean. This can be within or This rule is only to be one control across (within run) used within a run, not This can be within 10 consecutive runs 2 CONSECUTIVE across runs. one control across or values outside the 4 consecutive runs within 2 controls Ye s SAME 2 SD. or across 5 within 2 controls Ye s across 2 consecutive runs. Ye s consecutive runs. Ye s Ye s Out-of-Control, Reject Analytical Run Problem: Resolution: HOOD05162002658134 Effective Date: 09/05/2017 Modern "Westgard Rules": N's of 2 and 4 Date: Tech: Control Data In-Control Report Data No 13s 22s R4s 41s 8x No No No 4 CONSECUTIVE No one point (across runs) The range control values on 8 CONSECUTIVE outside 3 SD 2 CONSECUTIVE (difference) between one side of the values on ONE values on ONE values outside the two controls within a mean and further side of the mean. same 2 SD run exceeds 4 SDs. than 1SD from This can be within or This rule is only to be the mean. one control across (within run) used within a run, not This can be within 8 consecutive runs 2 CONSECUTIVE across runs. one control across or values outside the 4 consecutive runs within 2 controls Yes SAME 2 SD. or across 4 within 2 controls Yes across 2 consecutive runs. Yes consecutive runs. Yes Yes Out-of-Control, Reject Analytical Run Problem: Resolution: HOOD05162002658134 Effective Date: 09/05/2017 Modern "Westgard Rules": N's of 3 and 6 Date: Tech: Control Data In-Control Report Data No 13s 2of3 2s R 4s 31s 6x No No No 3 CONSECUTIVE No one point (across runs) The range control values on 6 CONSECUTIVE outside 3 SD 2 out of the last 3 (difference) between one side of the values on ONE values outside the two controls within a mean and further side of the mean. same 2 SD run exceeds 4 SDs. than 1SD from or This rule is only to be the mean. This can be within one control across (within run) used within a run, not This can be within 6 consecutive runs 2 out of the last 3 across runs. one control across or values outside the 3 consecutive runs within 3 controls Yes SAME 2 SD. or across 2 within 3 controls Yes across 1 consecutive runs, etc. Yes consecutive run. Yes Yes Out-of-Control, Reject Analytical Run Problem: Resolution: HOOD05162002658134 Effective Date: 09/05/2017 Westgard QC Order Form Item Price (US$) Quantity Subtotal Westgard software and reference manuals EZ Rules® 3 QC Design software NEW! The Poor Lab’s Guide to the Regulations NEW! Six Sigma Risk Analysis Most Popular! Basic QC Practices manual, 3rd Edition Six Sigma Quality Design & Control, 2nd Edition Assuring the Right Quality Right (Advanced Quality Management) Basic Method Validation, 3rd Edition CLIA Final Rules for Quality manual Westgard Online Courses Introduction to Risk Analysis for the Laboratory (4 credits) Quality Management and Design of Analytical Systems (5 credits) "Westgard Rules" and Levey-Jennings Charts minicourse (3 credits) Basic QC Practices – complete online course (14 credits) Basic Method Validation – complete online course (15 credits) Grand Subtotal Shipping & Handling: Within US = Canada & Mexico = Add 10%; Europe, Asia, & all other countries = Add 20% Sales Tax (Add 5.5% in WI, 6.0% in CT) GRAND TOTAL Your Name Institution Department Street Address City State Zip Code Country Business Phone/Business Fax E-mail Address Credit Card Type (circle one) VISA Mastercard American Express Credit Card Number Exp. Date Signature HOOD05162002658134 Effective Date: 09/05/2017

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  • westgard rules
  • 1 2s
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  • r 4s
  • 4 1s
  • 10x
  • 2 of 3 2s
  • 6x