IDQTF Uniform Federal Policy for Implementing Environmental Quality Systems

2.0 QUALITY SYSTEM AND DESCRIPTION

This section specifies that organizations must document a Quality System in a QMP or equivalent document. Any QMP written in conformance with this UFP will also be in conformance with ANSI/ASQC E4.

While this UFP establishes specific requirements for documenting a Quality System, it is not necessary to write a lengthy narrative that sequentially addresses each requirement. Tables and other simplifying charts are useful tools for communicating this information. For example, most of the requirements found in Section 1.1 a-c can be consolidated and addressed in a table such as the one below.

Example Table Headings for Section 1.1 of the QMP.

Whether documented in a Quality Management Plan organized in the manner of this document or in some equivalent document, writing down the Quality System processes and procedures is the foundation for a Quality System. Documented processes are the starting place for communication of responsibilities and requirements throughout the organization. Common expectations, when documented, yield accountability.

2.1 Documentation of the Quality System

1. The Quality System of an organization performing environmental data collection and implementing environmental technology programs must be formally documented in a QMP or an equivalent document.

   Other Documents Included in Quality System Documentation:

   The Quality System itself will include other documents, such as Quality Assurance Project Plans and standard operating procedures. Furthermore, documents may be in electronic format when the controls in Section 5.0 are applied to the electronic document system.

2. The QMP or equivalent document for each organization must also describe the subdivisions of the organization required to provide either separate QMPs or supplemental information to be referenced in the parent organization’s QMP. Responsibilities for receiving and incorporating supplemental information into the organization’s QMP must be identified.

3. If documentation of the Quality System is not consistent with the headings of this document, state how the organization’s Quality System is documented and provide cross-references to the UFP.

4. Describe the roles and responsibilities of senior management and QA personnel for developing, reviewing, approving, and revising Quality System documentation. Describe the frequency (at least annually) with which Quality System documentation must be reviewed and updated.

   Updating QMPs:

   Many aspects of the Quality System will remain constant over a number of years:

   • An annual update of the entire QMP is not necessary (although an annual review must be performed).

   • Frequent updates are needed only to change certain aspects (e.g., organizational changes, designated quality management personnel).

   • Elements of the QMP that are subject to frequent change can best be handled as tables and/or appendices that can be easily revised, or they can be referenced or linked to other readily available documents.

   • The initial QMP or equivalent document should include the expected schedule for updates, such as “annually if needed.”

5. For each program in the organization, provide a list of all other quality-related documents, including suborganization QMPs, program management plans, quality manuals, organizational policy statements, requirements and guidance documents, and standard operating procedures.

   Identifying Other Quality-Related Documents:

   This requirement can be accomplished either by attaching a list or by identifying (1) where the list is maintained, (2) the process for maintaining the list, and (3) personnel responsible for maintaining the list.

6. Provide a signature page for the QMP that demonstrates that (1) the QMP (or equivalent document) is the official policy of the organization, and (2) the QMP has been reviewed and approved for implementation by both senior management and QA staff.

   Electronic Reviews and Approvals:

   Reviews and approvals may be “electronic” when users and stakeholders have access to electronic document control systems and the policy of the organization allows electronic approvals.

2.2 Quality System Tools

The QMP must discuss the principal tools utilized in the Quality System and describe how they are used to implement the Quality System. These tools include, but are not limited to, QMPs, management assessments (self and independent), Systematic Planning Processes, QAPPs, requirements and guidance documents, standard operating procedures, technical assessments (self and independent), data quality assessments, and corrective action tools. The discussion must also identify how and when these tools of the Quality System are to be applied to individual products, services, and activities.

Table Format Ties Quality System Tools to Function:

A table may be a useful way of tying products, services, and activities to specific quality tools. A few examples are provided below:

Previous Section: 1.0 Management and Organization
Next Section: 3.0 Personnel Qualification and Training