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2.13.1 Quality assurance and quality control

The goal of quality assurance and quality control (QA/QC) is to identify and implement methodologies and procedures which limit the introduction of errors into the remediation process. For EURSSEM a system is needed to ensure that plans are of the type and quality needed and expected for their intended use in an environmental remediation process.

A quality system is a management system that describes the elements necessary to plan, implement, and assess the effectiveness of QA/QC activities. This system establishes many functions including: quality management policies and guidelines for the development of organization- and project-specific quality plans; criteria and guidelines for assessing data quality; assessments to ascertain effectiveness of QA/QC implementation; and training programs related to QA/QC implementation. A quality system ensures that EURSSEM decisions will be supported by sufficient data of adequate quality and usability for their intended purpose, and further ensures that such data are authentic, appropriately documented, and technically defensible.

Any organization collecting and evaluating methodologies, procedures or data for a particular program must be concerned with the quality of the results. The organization must have results that: meet a well-defined need, use, or purpose; comply with program requirements; and reflect consideration of health, environmental issues, cost and economics. To meet the objective, the organization should control the technical, administrative, and human factors affecting the quality of results. Control should be oriented toward the appraisal, reduction, elimination, and prevention of deficiencies that affect quality in a not wished manner.

Quality systems already exist for many organizations involved in the use of radioactive materials. There are self-imposed internal quality management systems or there are systems required by regulation or by another entity, which require a quality system as a condition of the operating license. These systems are typically called quality assurance programs. An organization may also obtain services from another organization that already has a quality system in place.

Table 2.14 illustrates elements of a quality system as they relate to the data life cycle. Applying a quality system to a project is typically done in three phases:

  1. The planning phase where the different data quality objectives (DQOs) are developed for the actions of an environmental remediation project and documented in the quality assurance project plan (QAPP)1;
  2. The implementation phase involving the actions, e.g., the collection of data in accordance with approved procedures and protocols;
  3. The assessment phase including the verification of actions and validation of survey results and the evaluation of the environmental data using data quality assessment (DQA) and audits.

Detailed guidance on quality systems is not provided in EURSSEM because a quality system should be in place and functioning prior to beginning environmental remediation activities [EPA-1997a], [ANSI-1995], [EPA-1994a].

Data life cycle Quality system elements

Planning Data quality objectives (DQOs)
Quality assurance project plans (QAPPs)
Standard operating procedures (SOPs)

Implementation Quality assurance project plans
Standard operating procedures
Data collection
Assessments and audits

Assessment Data validation and verification
Data quality assessment (DQA)
Audits

Table 2.14 The elements of a quality system related to the data life cycle

A graded approach bases the level of controls on the intended actions and use of the results and the degree of confidence needed in their quality. Applying a graded approach may mean that some organizations make use of existing plans and procedures to conduct an environmental remediation/restoration. For many other organizations, the need for clean-up and restoration of contaminated facilities may create the need for one or more quality assurance project plans suitable to the special needs of environmental data gathering, especially as it relates to the demonstration of compliance with regulatory requirements. There may even be a need to update or revise an existing quality management system.

1 EURSSEM uses, like MARSSIM, the term quality assurance project plan to describe a single document that incorporates all of the elements of the environmental remediation design. This term is consistent with ANSI/ASQC E4-1994 ([ANSI-1995]) and EPA guidance ([EPA-1997a][EPA-2002][EPA-1994a]), and is recommended to promote consistency. The use of the term quality assurance project plan (QAPP) in EURSSEM does not exclude the use of other terms (e.g., decommissioning plan, sampling and analysis plan, field sampling plan, remediation plan, health physics and safety plan, etc.) to describe planning documentation as long as the information in the documentation supports the objectives of the work to be performed.