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and revised Compliance Describe or reference process for ensuring pliance with all statutory, contractual, and assistance agreement requirements for records from environmental programs Computer Hardware and Software Overview: Computer Hardware and Software The QMP must describe QA and QC processes for the use of puter hardware and software to support environmental data operations General Requirements ? Computer hardware must be appropriate for its intended application ? Computer programs must be developed using an approved software development methodology Examples of Hardware Covered ? Data acquisition/logging systems ? Computers used with analytical instruments ? Automated sampling systems in which system failure would adversely affect quality and potential usability of collected data for decisions Examples of Software Covered ? Programs ? Models ? Data bases ? Data analysis systems Hardware QA and QC Processes ? Describe or reference process for ensuring that puter hardware used in environmental programs meets technical requirements and quality expectations ? Describe or reference how changes to hardware will be controlled to assess impact of change on performance Software Development QA and QC Processes ? Describe or reference process for: – Developing puter software – Validating, verifying, and documenting software for its use – Assuring that software meets requirements of user IRM Policies ? Describe or reference process for ensuring: 1. That data and information produced and collected by puters meet applicable information resource management requirements and standards IRM Policies 2. That applicable EPA requirements for information resources management are addressed, including: ? Year 2023 pliance (Chapter 5) ? Security (Chapter 8) ? Privacy requirements (Chapter 11) Planning Overview: Planning ? Description of process for planning environmental programs ? Discussion of QAPP process ? Discussion of anization39。s process for ensuring that suppliers provide items and services that: – Are of known and documented quality – Meet the technical requirements Four Areas to Cover 1. Review and approval of procurement documents 2. Review and approval of QA responses to solicitations 3. Objective evidence of adequate quality from suppliers 4. QA document review and approval Review and Approval of Procurement Documents ? Describe process and responsibilities for ensuring that documentation clearly states: – Item or service required – Technical and quality requirements – Quality System elements that the supplier is responsible for – How supplier39。d) 2. List parts of the anization that are required to prepare QMPs 3. Discuss the review and approval process for QMPs from external anizations ORGANIZATION/PROGRAMPROJECTPOLICY/REGULATIONSD e f e n s i b l e P r o d u c t s a n d D e c i s i o n sE P A P r o g r a m R e g i o n a l P o l i c yE x t e r n a l P o l i c i e sC o n t r a c t s 4 8 C F R 4 6A s s i s t a n c e A g r e e m e n t s 4 0 C F R 3 0 , 3 1 , a n d 3 5I n t e r n a l E P A P o l i c i e sE P A O r d e r 5 3 6 0 . 1E P A M a n u a l 5 3 6 0C o n s e n s u s S t a n d a r d sA N S I / A S Q C E 4I S O 9 0 0 0 S e r i e sA n n u a l R e v i e w a n d P l a n n i n g ( e . g . , Q A A R W P )S y s t e m sA s s e s s m e n t s( e . g . , Q S A s )Q u a l i t y S y s t e mD o c u m e n t a t i o n( e . g . , Q M P )T r a i n i n g / C o m m u n i c a t i o n( e . g . , T r a i n i n g P l a n , C o n f e r e n c e s )S u p p o r t i n g S y s t e m E l e m e n t s( e . g . , P r o c u r e m e n t s , C o m p u t e r H a r d w a r e / S o f t w a r e