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ANSI/ASQ E4-2004: Gary L. Johnson U.S. Epa Research Triangle Park, NC 27711 September 2004 ASQ/EED National Conference

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ANSI/ASQ E4-2004 Overview

Gary L. Johnson U.S. EPA Research Triangle Park, NC 27711 Se !e"#er 2$$% AS&'EE( Na!ional Con)erence

Today We Will
* +rie)ly ,escri#e ANS-'AS& E%.2$$% an, i!s #ene)i!s as a &/S s!an,ar,. * 01!line !he ANS- a ro2al rocess. * Pro2i,e an o2er2ie3 o) !he re2ise, s!an,ar, an, 3ha! has change,. * S1""ari4e !he s!a!1s o) s!an,ar,.

What is ANSI/ASQ E4-2004?


* An consens1s.#ase, A"erican Na!ional S!an,ar, )or 51ali!y "anage"en! sys!e"s )or en2iron"en!al sec!or rogra"s. * (e2elo e, #y AS& an, !he ANS- 61 Accre,i!e, S!an,ar,s Co""i!!ee.

What does ANSI/ASQ E4-2004 do?


* Pro2i,es s eci)ic &/S s eci)ica!ions )or7
8 &1ali!y /anage"en! rac!ices 8 En2iron"en!al ,a!a collec!ion an, 1se 8 (esign, cons!r1c!ion, an, o era!ion o) engineere, !echnology

* Pro2i,es g1i,ance on !he 1se o) E%, incl1,ing going #eyon, !he "ini"1" s eci)ica!ions.

ANSI/ASQ E4-2000 Bac !ro"#d


* 0riginally ANS-'AS&C E%.199%7
8 (e2elo e, #y AS& Energy an, En2iron"en!al (i2ision :EE(; 8 (eri2e, )ro" se2eral e<is!ing s!an,ar,s an, ro!ocols :AS/E N&A.1, -S0 9$$1, EPA &/S g1i,ance;

* A,o !e, as #asis )or U.S. EPA &1ali!y Policy in 199=.


8 EPA 0r,er >?@$.1

ANSI/ASQ E4-2000 Bac !ro"#d co#ti#"ed


* A,,e, !o Ae,eral Ac51isi!ion Reg1la!ions in 1999.
8 %= CAR Par! %@ 8 BCigh Le2elD &1ali!y Ass1rance s!an,ar,

* E% a,o !ion as a sec!or.s eci)ic s!an,ar, )or en2iron"en!al rogra"s incl1,es7


8 0!her Ae,eral ,e ar!"en!s an, agencies 8 S!a!e an, local go2ern"en!s

A$erica# Natio#al Sta#dards


* A"erican Na!ional S!an,ar,s are7
8 (e2elo e, #y ANS-.a ro2e, S!an,ar,s (e2elo "en! 0rgani4a!ions 8 S1#Eec! !o e<!ensi2e consens1s re2ie3 an, 1#lic co""en! 8 A ro2e, #y ANS- )or 1 !o )i2e years.

* ANS- r1les re51ire erio,ic re2ie3 !o7


8 Re.a1!hori4e !he s!an,ar, 3i!ho1! change 8 Fi!h,ra3 !he s!an,ar, 8 Re2ise !he s!an,ar,.

ANSI %eview o& E4


* ANS-'AS&C E%.199% 3as re2ie3e, er ANS- r1les.
8 AS& EE( )or"e, !he E% Fork Gro1 8 S1r2ey o) 1sers 8 (e!er"ine, !ha! "o,es! re2ision 3as nee,e,.

* Consens1s +o,y 3as !he ANS- ASC 61 &1ali!y /anage"en! S1#co""i!!ee. * E% Fork Gro1 re are, re2ise, !e<!.

ANSI %eview o& E4


* 61 an, P1#lic Re2ie3s
8 P1#lic re2ie3s ro,1ce, )e3 co""en!s. 8 61 re2ie3s ro,1ce, se2eral i" ro2e"en!s !o !he s!an,ar,.

* ANS- a ro2al o) re2ise, s!an,ar, co" le!e, on Ae#r1ary %, 2$$%.

O'(ectives o& E4 %evisio#


* Ae3 s1#s!an!i2e !echnical changes. * Si" li)y s!r1c!1re an, resen!a!ion o) re51ire"en!s an, g1i,ance. * Align E% 3i!h -S0 9$$172$$$ !o !he e<!en! rac!ica#le.

A))roach to %evisio#s
* Change !he resen!a!ion )or"a!
8 Use -S0 s!yle an, )or"a! 8 Use -S0 9$$$72$$$ !er"s an, ,e)ini!ions 3here ossi#le 8 Se ara!e g1i,ance )ro" s eci)ica!ions an, lace in an Anne<

* Pro2i,e a cross re)erence !o -S0 9$$172$$$ )or consis!ency an, align"en!. * -ncor ora!e Blessons learne,D )ro" 199% E% i" le"en!a!ion an, 1se.

Str"ct"re o& ANSI/ASQ E4-2004


Aore3or, $ -n!ro,1c!ion 1 Sco e 2 General Princi les an, A lica!ions ? Nor"a!i2e Re)erences % Ter"s an, (e)ini!ions > /anage"en! Sys!e"s @ Collec!ion an, E2al1a!ion o) En2iron"en!al (a!a

Str"ct"re o& ANSI/ASQ E4-2004


7 (esign, Cons!r1c!ion an, 0 era!ion o) En2iron"en!al Technology Ter"s an, (e)ini!ions G1i,elines on !he Use o) ANS-'AS& E% Cross3alk #e!3een ANS-'AS& an, -S0 9$$172$$$

Anne< A Anne< + Anne< C E%

*oreword
* Pro2i,es general #ackgro1n, on ANSs!an,ar,s. * Cre,i!s !hose res onsi#le )or s!an,ar,.
8 ANS- ASC 61 Co""i!!ee 8 AS& Energy an, En2iron"en!al (i2ision 8 E% Fork Gro1

* -n,ica!es !ha! !his e,i!ion re laces !he 199% 2ersion in i!s en!ire!y.

I#trod"ctio#

* Pro2i,es general s!a!e"en! on 1r ose o) E% s!an,ar,.


8 &/S )or en2iron"en!al rogra"s 8 /ini"1" se! o) re51ire"en!s 8 Pro2i,es )or non"an,a!ory g1i,elines

* Co" a!i#ili!y 3i!h o!her "anage"en! sys!e"s.


8 -S0 9$$$ series 8 No! an E/S s!an,ar,

* No! an a1,i!a#le ar! o) !he s!an,ar,.

Sco)e

* +rie) s!a!e"en! o) !he in!en! an, organi4a!ional a lica#ili!y o) !he s!an,ar,.


8 E% is a s eci)ica!ion or re51ire"en!s s!an,ar,

* E" hasi4es )le<i#ili!y an, #roa, range o) 1sers.

,e#eral -ri#ci)les a#d A))licatio#s

* +rie) s!a!e"en! o) !he general rinci les 1se,7


8 &1ali!y sys!e" as a )ra"e3ork )or &A an, &C. 8 Planning, i" le"en!a!ion, an, assess"en!. 8 Use o) Bgra,e, a roach.D 8 Re!ains "o,1lar ,esign )ro" 199% 2ersion.

* No!es en2iron"en!al rogra"s !o 3hich E% "ay #e a lie,.

Nor$ative %e&ere#ces

* -,en!i)ies o!her ,oc1"en!s 3hose ro2isions are incl1,e, in ANS-'AS& E%. 2$$% #y re)erence. * There are !3o nor"a!i2e re)erences7
8 ISO /00002000 8 ISO +40300+//4 Q1S 2oca'"lary E1S 2oca'"lary

Ter$s a#d 5e&i#itio#s

* Pro2i,es )or a,,i!ional ,e)ini!ions no! s eci)ically co2ere, in nor"a!i2e re)erences or Anne< A. * Gey !er"s incl1,e7
8 8 8 8 8 En2iron"en!al ,a!a En2iron"en!al ,a!a o era!ions En2iron"en!al rocesses En2iron"en!al rogra"s En2iron"en!al !echnology

1a#a!e$e#t Syste$s 6-art A7

* Pro2i,es cri!eria )or es!a#lishing an, "ain!aining an e))ec!i2e 51ali!y sys!e". * &1ali!y "anage"en! ele"en!s "1s! #e 1se, 3i!h Cla1se @ or Cla1se 7 re51ire"en!s !o co" le!e !he &/S.

1a#a!e$e#t Syste$s 6-art A7 co#ti#"ed


8 8 8 8 8 8 8 8 8 8 /anage"en! an, organi4a!ion &1ali!y sys!e" an, ,escri !ion Personnel 51ali)ica!ion an, !raining Proc1re"en! o) i!e"s an, ser2ices (oc1"en!s an, recor,s Co" 1!er har,3are an, so)!3are Planning -" le"en!a!ion o) 3ork rocesses Assess"en! an, res onse &1ali!y i" ro2e"en!

* &1ali!y "anage"en! ele"en!s incl1,e7

1a#a!e$e#t Syste$s 6-art A7 co#ti#"ed


8 (e)ine "anage"en! roles an, res onsi#ili!ies 8 Re51ire a &A /anager 3ho re or!s !o !o "anage"en! an, 3ho has organi4a!ional in,e en,ence 8 S eci)y )1nc!ional res onsi#ili!ies 3i!hin !he organi4a!ion. 8 Re51ire a &1ali!y /anage"en! Plan. 8 Re51ire erio,ic "anage"en! re2ie3.

* &1ali!y "anage"en! ele"en!s7

9ollectio# a#d Eval"atio# o& E#viro#$e#tal 5ata 6-art B7

* Cla1se @ ele"en!s incl1,e7


8 8 8 8 8 Planning an, sco ing (esign o) ,a!a collec!ion o era!ions -" le"en!a!ion o) lanne, o era!ions Assess"en! an, res onse Assess"en! an, 2eri)ica!ion o) ,a!a 1sa#ili!y

* Ae3 changes )ro" 199% 2ersion.

: 5esi!#; 9o#str"ctio#; a#d O)eratio# o& E#viro#$e#tal Tech#olo!y 6-art 97


* Cla1se 7 re51ire"en!s incl1,e7
8 Planning 8 (esign o) sys!e"s 8 Cons!r1c!ion')a#rica!ion o) sys!e"s an, co" onen!s 8 Tes!ing an, o era!ion o) sys!e"s 8 Assess"en! an, res onse 8 Heri)ica!ion an, acce !ance o) sys!e"s

A##e< A Ter$s a#d 5e&i#itio#s


* E< an,e, lis! o) rela!e, !er"s an, !heir ,e)ini!ions. * -S0 9$$$72$$$ ,e)ini!ions 1se, 3here a lica#le.
8 Cel s !o achie2e co" a!i#ili!y 3i!h -S0 9$$1.

A##e< B ,"ideli#es o# the =se o& ANSI/ASQ E4


* Pro2i,es non"an,a!ory g1i,elines !o a1g"en! s eci)ica!ions gi2en in !his s!an,ar,. * G1i,ance is gro1 e, as7
8 General 1se o) !he s!an,ar,. 8 G1i,elines )or "anage"en! sys!e"s. 8 G1i,elines )or collec!ion an, e2al1a!ion o) en2iron"en!al ,a!a. 8 G1i,elines )or !he ,esign, cons!r1c!ion, an, o era!ion o) en2iron"en!al !echnology

A##e< 9 9rosswal Betwee# ANSI/ASQ E4 a#d ISO /00+


* Pro2i,es cross3alk #e!3een !his s!an,ar, an, -S0 9$$172$$$. * -,en!i)ies e51i2alen! cla1ses in each s!an,ar,. * Sho3s !ha! E% a,,resses all o) !he re51ire"en!s o) -S0 9$$172$$$.

S"$$ary
* ANS-'AS& E%.2$$% is an a ro2e, A"erican Na!ional S!an,ar,. * ANS-'AS& E% is a recogni4e, -S0 9$$1 e51i2alen! s!an,ar,.
8 Regis!rar Accre,i!a!ion +oar, :RA+; 8 E% a1,i!s are acce !a#le )or RA+ &/S A1,i!or an, Lea, A1,i!or cer!i)ica!ion

* Ne<! s!e s incl1,e re2ision o) EPA olicy ,oc1"en!s !o a,o ! c1rren! 2ersion.

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