the cap inspection and accreditation program at age 50 - American ...
the cap inspection and accreditation program at age 50 - American ...
the cap inspection and accreditation program at age 50 - American ...
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Rel<strong>at</strong>ionship of CAP I5189 to CAP LAPRel<strong>at</strong>ionship of 15189, Lean, & Six Sigma15189• Voluntary in U.S.• Focus on overallquality system• Goal is failureresistant system• Scope goes beyondlabCAP LAP• Based on CLIA(CLIA required inU.S. not CAP)• Focus on technicalprocedures• Goal is valid currentpractices• Scope focused on labISO – overarching quality man<strong>age</strong>ment systemLean, Six Sigma – specific methodologies used within qualityman<strong>age</strong>ment system• Lean:• Designed to reduce waste• Developed by automotive industry (Toyota)• Six Sigma –• Designed to reduce production defects• Developed by Motorola©2008 College of <strong>American</strong> P<strong>at</strong>hologists. All rights reserved.Every number is a life.©2008 College of <strong>American</strong> P<strong>at</strong>hologists. All rights reserved.Sakichi Toyoda (1867 - 1930豊 ⽥ 佐 吉 ) was a Japanese inventor <strong>and</strong>industrialist.Every number is a life.Man<strong>age</strong>ment RequirementsMan<strong>age</strong>ment Requirements4.1 Organize <strong>and</strong> staff <strong>the</strong>lab so it can support aQMS (Quality Man<strong>age</strong>mentSystem).• Have a man<strong>age</strong>r whocan focus on quality,versus fighting brushfires.©2008 College of <strong>American</strong> P<strong>at</strong>hologists. All rights reserved.Every number is a life.©2008 College of <strong>American</strong> P<strong>at</strong>hologists. All rights reserved.Every number is a life.Man<strong>age</strong>ment RequirementsMan<strong>age</strong>ment Requirements4.2 Cre<strong>at</strong>e a complete QMS,(Quality Man<strong>age</strong>mentSystem) including• Resources / infrastructure• Document<strong>at</strong>ion (based on analysis of work)• Goals & metrics• Quality activities – internal audit, corrective action,man<strong>age</strong>ment review, training, etc.4.4 Scrutinize contracts. Don’t take work you can’t do.4.5 Scrutinize referral labs; proactively assess <strong>the</strong>ir quality.4.6 Proactively assess quality of suppliers. Control yourinventory.4.3 Control your documents so tasks are done in aconsistent, accur<strong>at</strong>e manner.©2008 College of <strong>American</strong> P<strong>at</strong>hologists. All rights reserved.Every number is a life.©2008 College of <strong>American</strong> P<strong>at</strong>hologists. All rights reserved.Every number is a life.9
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