Guidance on Assessing Quality Systems

By Environmental Protection Agency

Book Id: WPLBN0000125717
Format Type: PDF eBook
File Size: 0.6 MB
Reproduction Date: 2007

Title:	Guidance on Assessing Quality Systems
Author:	Environmental Protection Agency
Volume:
Language:	English
Subject:	Ecology, Natural resource issues, Environemtal protection
Collections:	Environmental Awareness Library Collection
Historic Publication Date:
Publisher:	United States Environmental Protection Agency


Citation APA MLA Chicago Agency, E. P. (n.d.). Guidance on Assessing Quality Systems. Retrieved from http://www.self.gutenberg.org/

Description
Excerpt: FOREWORD The U.S. Environmental Protection Agency (EPA) has developed an Agency-wide program of quality assurance for environmental data that includes documentation of both management and technical activities. This guidance document, Guidance on Assessing Quality Systems, provides methods and tools for assessing quality systems and provides information about assessments for those who use them. It is pertinent to organizations that carry out environmental data operations within or for EPA.

Table of Contents
TABLE OF CONTENTS Page CHAPTER 1. ASSESSMENTS IN THE QUALITY SYSTEM . . . . . . . . . . . . . . . . . . . . . . . . 1 1.1 PURPOSE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1.2 QUALITY SYSTEM CONTEXT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1.3 ASSESSMENTS OF QUALITY SYSTEMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 1.4 SPECIFICATIONS FOR ASSESSMENTS OF QUALITY SYSTEMS . . . . . . . . 5 1.5 GRADED APPROACH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 1.6 INTENDED AUDIENCE AND PERIOD OF APPLICABILITY . . . . . . . . . . . . . . 7 1.7 ADDITIONAL REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 CHAPTER 2. MANAGING ASSESSMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 2.1 ASSESSMENT ROLES AND RESPONSIBILITIES . . . . . . . . . . . . . . . . . . . . . . . 9 2.2 ASSESSMENT SYSTEMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 2.3 DECISION TO CONDUCT THE ASSESSMENT . . . . . . . . . . . . . . . . . . . . . . . 12 2.4 CRITERIA FOR THE ASSESSMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 2.5 SCOPE OF THE ASSESSMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 2.6 THE ASSESSMENT TEAM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 2.6.1 Assessment Team Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 2.6.2 Assessment Team Leader Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . 15 2.6.3 Assessor Responsibilities and Qualifications . . . . . . . . . . . . . . . . . . . . . . . . 15 2.7 ASSESSMENT RESOURCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 CHAPTER 3. PREPARING FOR THE ASSESSMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 3.1 DOCUMENTATION AND TRACKING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 3.2 ASSESSMENT TEAM PREPARATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 3.3 INITIAL CONTACT WITH THE ASSESSEE . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 3.4 INFORMATION REVIEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 3.5 ISSUE SELECTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 3.6 IDENTIFY INTERVIEWEES AND DOCUMENTS . . . . . . . . . . . . . . . . . . . . . . 22 3.7 ALTERNATIVES TO ON-SITE INTERVIEWS . . . . . . . . . . . . . . . . . . . . . . . . . 24 3.8 PREPARATION OF THE ASSESSMENT PLAN . . . . . . . . . . . . . . . . . . . . . . . . 25 3.9 REVIEW AND APPROVAL OF THE ASSESSMENT PLAN . . . . . . . . . . . . . . 25 3.10 CONFIDENTIALITY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 3.11 COORDINATION AND LOGISTICAL ARRANGEMENTS . . . . . . . . . . . . . . . 27 3.12 FORMAL NOTIFICATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 3.13 CHECKLISTS AND OTHER AIDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 CHAPTER 4. CONDUCTING THE ASSESSMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 4.1 OPENING MEETING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36