Presentation on theme: "ANSI/ASQ E Overview Gary L. Johnson U.S. EPA"— Presentation transcript:
1 ANSI/ASQ E4-2004 Overview Gary L. Johnson U.S. EPA Research Triangle Park, NC 27711September 2004ASQ/EED National Conference
2 Today We WillBriefly describe ANSI/ASQ E and its benefits as a QMS standard.Outline the ANSI approval process.Provide an overview of the revised standard and what has changed.Summarize the status of standard.Scheduled for presentation at the February meeting.
3 What is ANSI/ASQ E4-2004?An consensus-based American National Standard for quality management systems for environmental sector programs.Developed by ASQ and the ANSI Z1 Accredited Standards Committee.
4 What does ANSI/ASQ E4-2004 do? Provides specific QMS specifications for:Quality Management practicesEnvironmental data collection and useDesign, construction, and operation of engineered technologyProvides guidance on the use of E4, including going beyond the minimum specifications.
5 ANSI/ASQ E4-2000 Background Originally ANSI/ASQC E4-1994:Developed by ASQ Energy and Environmental Division (EED)Derived from several existing standards and protocols (ASME NQA-1, ISO 9001, EPA QMS guidance)Adopted as basis for U.S. EPA Quality Policy in 1998.EPA Order
6 ANSI/ASQ E4-2000 Background continued Added to Federal Acquisition Regulations in 1999.48 CFR Part 46“High Level” Quality Assurance standardE4 adoption as a sector-specific standard for environmental programs includes:Other Federal departments and agenciesState and local governments
7 American National Standards American National Standards are:Developed by ANSI-approved Standards Development OrganizationsSubject to extensive consensus review and public commentApproved by ANSI for up to five years.ANSI rules require periodic review to:Re-authorize the standard without changeWithdraw the standardRevise the standard.
8 ANSI Review of E4 ANSI/ASQC E4-1994 was reviewed per ANSI rules. ASQ EED formed the E4 Work GroupSurvey of usersDetermined that modest revision was needed.Consensus Body was the ANSI ASC Z1 Quality Management Subcommittee.E4 Work Group prepared revised text.
9 ANSI Review of E4 Z1 and Public Reviews Public reviews produced few comments.Z1 reviews produced several improvements to the standard.ANSI approval of revised standard completed on February 4, 2004.
10 Objectives of E4 Revision Few substantive technical changes.Simplify structure and presentation of requirements and guidance.Align E4 with ISO 9001:2000 to the extent practicable.
11 Approach to Revisions Change the presentation format Use ISO style and formatUse ISO 9000:2000 terms and definitions where possibleSeparate guidance from specifications and place in an AnnexProvide a cross reference to ISO 9001:2000 for consistency and alignment.Incorporate “lessons learned” from 1994 E4 implementation and use.
12 Structure of ANSI/ASQ E4-2004 Foreword0 IntroductionScopeGeneral Principles and ApplicationsNormative ReferencesTerms and DefinitionsManagement SystemsCollection and Evaluation of Environmental Data
13 Structure of ANSI/ASQ E4-2004 Design, Construction and Operation of Environmental TechnologyAnnex A Terms and DefinitionsAnnex B Guidelines on the Use of ANSI/ASQ E4Annex C Crosswalk between ANSI/ASQ E4 and ISO 9001:2000
14 Foreword Provides general background on ANSI standards. Credits those responsible for standard.ANSI ASC Z1 CommitteeASQ Energy and Environmental DivisionE4 Work GroupIndicates that this edition replaces the 1994 version in its entirety.
15 0 Introduction Provides general statement on purpose of E4 standard. QMS for environmental programsMinimum set of requirementsProvides for nonmandatory guidelinesCompatibility with other management systems.ISO 9000 seriesNot an EMS standardNot an auditable part of the standard.
16 1 ScopeBrief statement of the intent and organizational applicability of the standard.E4 is a specification or requirements standardEmphasizes flexibility and broad range of users.
17 2 General Principles and Applications Brief statement of the general principles used:Quality system as a framework for QA and QC.Planning, implementation, and assessment.Use of “graded approach.”Retains modular design from 1994 version.Notes environmental programs to which E4 may be applied.
18 3 Normative ReferencesIdentifies other documents whose provisions are included in ANSI/ASQ E by reference.There are two normative references:ISO 9000:2000 QMS VocabularyISO 14050:1998 EMS Vocabulary
19 4 Terms and DefinitionsProvides for additional definitions not specifically covered in normative references or Annex A.Key terms include:Environmental dataEnvironmental data operationsEnvironmental processesEnvironmental programsEnvironmental technology
20 5 Management Systems (Part A) Provides criteria for establishing and maintaining an effective quality system.Quality management elements must be used with Clause 6 or Clause 7 requirements to complete the QMS.
21 5 Management Systems (Part A) continued Quality management elements include:Management and organizationQuality system and descriptionPersonnel qualification and trainingProcurement of items and servicesDocuments and recordsComputer hardware and softwarePlanningImplementation of work processesAssessment and responseQuality improvement
22 5 Management Systems (Part A) continued Quality management elements:Define management roles and responsibilitiesRequire a QA Manager who reports to top management and who has organizational independenceSpecify functional responsibilities within the organization.Require a Quality Management Plan.Require periodic management review.
23 6 Collection and Evaluation of Environmental Data (Part B) Clause 6 elements include:Planning and scopingDesign of data collection operationsImplementation of planned operationsAssessment and responseAssessment and verification of data usabilityFew changes from 1994 version.
24 7 Design, Construction, and Operation of Environmental Technology (Part C) Clause 7 requirements include:PlanningDesign of systemsConstruction/fabrication of systems and componentsTesting and operation of systemsAssessment and responseVerification and acceptance of systems
25 Annex A Terms and Definitions Expanded list of related terms and their definitions.ISO 9000:2000 definitions used where applicable.Helps to achieve compatibility with ISO 9001.
26 Annex B Guidelines on the Use of ANSI/ASQ E4 Provides nonmandatory guidelines to augment specifications given in this standard.Guidance is grouped as:General use of the standard.Guidelines for management systems.Guidelines for collection and evaluation of environmental data.Guidelines for the design, construction, and operation of environmental technology
27 Annex C Crosswalk Between ANSI/ASQ E4 and ISO 9001 Provides crosswalk between this standard and ISO 9001:2000.Identifies equivalent clauses in each standard.Shows that E4 addresses all of the requirements of ISO 9001:2000.
28 Summary ANSI/ASQ E4-2004 is an approved American National Standard. ANSI/ASQ E4 is a recognized ISO 9001 equivalent standard.Registrar Accreditation Board (RAB)E4 audits are acceptable for RAB QMS Auditor and Lead Auditor certificationNext steps include revision of EPA policy documents to adopt current version.