Final Checklist: QMP Reviews

Revision No.: 2
Date: September 28, 2001
Page: 1 of 13

CHECKLIST FOR REVIEWING

EPA QUALITY MANAGEMENT PLANS

This checklist will be used to review the Quality Management Plans (QMPs) that are submitted to the Quality Staff of the Office of
Environmental Information (OEI) for Agency review under EPA Order 5360.1 A2. Items from this checklist are discussed in detail in
Chapter 3 of EPA Manual 5360 A1 and in EPA Requirements for Quality Management Plans (QA/R-2). Consult these resources for more
information on the items below.

Note that all items below must be included in a QMP. If an item is not relevant, an explanation must be provided. Also note that process may
either be described or referenced in the QMP; however, all references should be readily accessible within the organization and provided to the
Quality Staff with the QMP.

Page(s) Comments

MANAGEMENT AND ORGANIZATION

1. Signed and dated by senior manager?
2. Signed and dated by senior line management?
3. Signed and dated QA manager?
4. Includes signature lines for Quality Staff approval?
5. Includes signature lines for OEI approval?
6. Includes statement of the organization's QA policy?
6a. QA policy statement includes general objectives/goals?
6b. QA policy statement includes allocation of intramural,
extramural, and travel funds and personnel?
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Date: September 28, 2001
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Page(s) Comments
7. Includes organizational chart?
7a. Organizational chart identifies all components of
organization?
7b. Organizational Chart identifies position of QA manager?
7c. Organizational Chart identifies lines of reporting of the QA
manager?
7d. Organization Chart identifies any other QA staff?

8. Includes discussion of authorities of the QA manager and staff?

9. Documents the independence of QA manager?

10. Describes procedures to ensure QA staff have access to

appropriate levels of management?

11. Discusses technical activities or programs that require quality

management?

12. Discusses where oversight of delegated or extramural programs is

needed?
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Page(s) Comments
13. Identifies where internal coordination of QA and QC activities
among organizations is needed?

14. Discusses how management assures understanding and

implementation in all programs?

15. Describes process for resolving disputes?

QUALITY SYSTEM COMPONENTS

16. Includes description of quality system?

17. Describes principal quality system components (e.g., quality

system documentation, annual reviews and planning, project-
specific quality documentation? (Note, identify components in
Column 3.)
18. Description of components includes how they are implemented?

19. Description of components includes responsibilities of

management and staff?

20. Lists tools for implementing each component (e.g., QMPs, Quality
Systems Audits, Training Plans, QA Project Plans? (Note: list
tools in Column 3.)
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Date: September 28, 2001
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Page(s) Comments
21. Identifies internal organizations that develop QMPs?

22. Identifies review and approval procedures for these internal

QMPs?

23. Includes assurance that QA responsibility is incorporated into

performance standards (consistent with Agency personnel
policy)?

QUALIFICATIONS AND TRAINING

24. States policy regarding QA training for management and staff?

25. Describes process for identifying, ensuring, and documenting that

personnel have necessary quality-related qualifications?

26. Describes process for ensuring personnel maintain quality-related

qualifications?

27. Describes process for identifying the need for quality-related

retraining based on changing requirements?

28. Includes roles, responsibilities, and authorities in description of

above processes?
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Page(s) Comments

PROCUREMENT OF ITEMS AND SERVICES

29. Describes process for reviewing and approving all extramural
agreements (grants, cooperative agreements and contracts)?
29a. Review process ensures documents are complete and
accurate?
29b. Review process ensures agreement clearly describes the
item or service needed?
29c. Review process ensures agreement describes the associated
technical and quality requirements?
29d. Review process ensures agreement describes the quality
system elements for which the supplier is responsible?
29e. Review process ensures that the supplier’s conformance to
the customer’s requirements will be verified?
30. Describes process for reviewing and approving applicable
responses to solicitations to ensure that they satisfy all technical
and quality requirements?
30a. Review process ensures the review of evidence of the
supplier’s capability to satisfy EPA quality requirements?
30b. Review process ensures procured items and services are
acceptable?

31. Describes process for review and approval of suppliers’ quality-

related documentation (e.g., QA Project Plans and QMPs)?
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Page(s) Comments
32. Includes discussion of any policy and criteria for delegations of
review of QA Project Plans and QMPs?

33. Describes process to ensure EPA extramural agreement policies

satisfied?

34. Includes roles, responsibilities, and authorities in description of

above processes?

DOCUMENTS AND RECORDS

35. Describes process for identifying quality-related documents and
records (including electronic) requiring control?

36. Describes process for preparing, reviewing, approving, issuing,

using, authenticating, and revising documents and records?
37. Describes process for ensuring that records and documents
accurately reflect completed work?

38. Describes process for maintaining documents and records

including transmittal, distribution, retention, access, preservation,
traceability, retrieval, removal of obsolete documentation, and
disposition?
39. Describes process for establishing and implementing appropriate
chain of custody and confidentiality procedures for evidentiary
records?
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Page(s) Comments
40. Above processes comply with EPA Order 2160 and EPA
Directive 2100, Chapter 10?

41. Includes roles, responsibilities, and authorities in description of

above processes?

COMPUTER HARDWARE AND SOFTWARE

42. Describes process for developing, installing, testing, using,
maintaining, controlling, and documenting computer hardware and
software?
43. Describes process for assessing and documenting the impact of
changes to user requirements and/or the hardware and software
on performance?
44. Describes process for evaluating purchased hardware and
software?

45. Describes process for ensuring that data and information

produced from or collected by computers meet applicable
requirements and standards?
46. Includes roles, responsibilities, and authorities in description of
above processes?

47. Are the requirements of EPA Directive 2100 are addressed in the
above processes?
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Page(s) Comments

PLANNING
48. Includes a description of the systematic planning process for
environmental data operations?
48a. Does process include identification and involvement of all
customers and suppliers?
48b. Does process include description of the project goal,
objectives, and questions and issues to be addressed?
48c. Does process include identification of project schedule,
resources, milestones, and any applicable requirements?
48d. Does process include identification of the type and quantity
of data needed and how the data will be used to support the
project’s objectives?
48e. Does process include specification of performance criteria
for measuring quality?
48f. Does process include specification of needed QA and QC
activities to assess the quality performance criteria?
48g. Does process include description of how, when, and where
the data will be obtained (including existing data) and
identification of any constraints on data collection?
48h. Does process include description of how the acquired data
will be analyzed, evaluated, and assessed against its
intended use and the quality performance criteria?
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Page(s) Comments
49. Describes process for developing, reviewing, approving,
implementing, and revising QA Project Plans?

50. Describes process for evaluating and qualifying data collected for
other purposes or from other sources?

51. Includes roles, responsibilities, and authorities in description of

above processes?

IMPLEMENTATION OF WORK PROCESSES

52. Describes process for ensuring that work is performed according
to planning and technical documents?

53. Describes process for identifying operations needing procedures?

54. Describes process for preparation, review, approval, revision, and

withdrawal of these procedures?

55. Describes policy for use of these procedures?

56. Describes process for controlling and documenting the release,

change, and use of planned procedures?
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Page(s) Comments
56a. Process includes description of necessary approvals?

56b. Process includes removal of obsolete documentation from

work areas?
56c. Process includes verification that the changes are made as
prescribed?
57. Includes roles, responsibilities, and authorities in description of
above process?

ASSESSMENT AND RESPONSE

58. Describes the process for assessing the adequacy of the quality
system at least annually?

59. Describes the process for planning, implementing and

documenting assessments and reporting results to management?
59a. Process includes selecting an assessment tool, the expected
frequency, and the roles and responsibilities of assessors?
59b. Process includes determining the level of competence,
experience and training needed for assessment personnel?
59c. Process includes ensuring that personnel have no real or
perceived conflict of interest, and have no direct
involvement or responsibility for the work being assessed?
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Page(s) Comments
59d. Process includes ensuring that personnel conducting
assessments have sufficient authority, access to programs
and managers, access to documents and records, and
organizational freedom?
60. Describes process for management’s review of, and response to,
findings?

61. Describes process for identifying how and when corrective actions
are to be taken in response to the findings of the assessment?
61a. Process includes ensuring corrective actions are made
promptly?
61b. Process includes confirming the implementation and
effectiveness of any corrective action?
61c. Process includes documenting actions?

62. Describes process for addressing disputes encountered as a result

of assessments?

63. Includes roles, responsibilities, and authorities in description of

above processes?
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Date: September 28, 2001
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Page(s) Comments

QUALITY IMPROVEMENT
64. Describes process for ensuring that conditions adverse to quality
are prevented, identified promptly, corrected promptly and that
actions are taken toward prevention, documented and actions
tracked to closure?
65. Describes process for encouraging staff to establish
communications between customers and suppliers, identify
process improvement opportunities, and identify and propose
solutions for problems?
66. Includes roles, responsibilities, and authorities in description of
above processes?

OTHER REVIEW CRITERIA

67. Are regulatory or other citations accurate?

68. Are there any inconsistencies in the text?

69. Is the writing clear?

70. Are organizational units identified consistent with the most recent
reorganization?
71. Are past QS management assessment findings resolved? (Put date
of Final Report in Column 3.)
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Date: September 28, 2001
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Page(s) Comments
72. Are activities described in the QMP consistent with QA Annual
Report and Work Plans?
73. Are tasks proposed for other organizations not covered solely by
this QMP documented elsewhere (e.g., in another organization’s
QMP)?
 ATTACHMENT 2
EPA-SPECIFIC QUALITY MANAGEMENT PLAN REQUIREMENTS

The following items from the Checklist for Reviewing EPA Quality Management Plans are only
applicable for EPA QMPs required under EPA Order 5360.1 CHG 1 (July 1998):

4. Signature line for Quality Staff

5. Signature lines for OEI approval1
15. Dispute resolution process
23. Performance standards
30a. Review and approval of responses to solicitations to ensure they satisfy EPA quality
requirements
31. Review and approval of quality-related documentation from suppliers
32. Policy and criteria for delegating approval of quality-related documentation
33. Process to ensure EPA contracting policies satisfied
40. Conformance to EPA Order 2160 and EPA Directive 2100, Chapter 10

1
For non-EPA organizations, if EPA approval of a QMP is required, the approval page must include a
section for the signature of the responsible EPA official.

15