Chapter 8 : Tool Quality Assurance Process

8.0 TOOL QUALITY ASSURANCE PROCESS
This section discusses the objectives and activities of the tool quality assurance (TQA) process. The TQA process is applied as defined by the tool qualification planning process (section 4) and the Tool Quality Assurance Plan (see 10.1.6). Outputs of the TQA process activities are recorded in Tool Quality Assurance Records (see 10.1.14) or other tool life cycle data.
The TQA process assesses the tool life cycle processes and their outputs to obtain assurance that:

a. Objectives are satisfied.

b. Deficiencies are detected, evaluated, tracked, and resolved.

c. The tool product and tool life cycle data conform to this document and additional regulatory requirements, if any.

8.1 Tool Quality Assurance Process Objectives
The TQA process objectives provide confidence that the tool life cycle processes produce a tool that conforms to its requirements by assuring that these processes are performed in compliance with the approved tool plans and standards, including the Tool-specific information in the PSAC.
The objectives of the TQA process are to:

a. Obtain assurance that tool development plans and standards including the Tool-specific information in the PSAC are developed and reviewed for consistency.

b. Obtain assurance that tool development processes and integral processes, including those of suppliers, comply with approved tool plans and standards including the Tool-specific information in the PSAC.

c. Obtain assurance that the transition criteria for the tool life cycle processes are satisfied.

d. Conduct a conformity review of the tool product.
The applicability of the objectives by TQL is specified in Table T-9 of Annex A.

8.2 Tool Quality Assurance Process Activities
Activities for satisfying the TQA process objectives include:

a. Those performing the TQA process should take an active role in the activities of the tool life cycle processes, and have the authority, responsibility, and independence to ensure that the TQA process objectives are satisfied.

b. The TQA process should provide assurance that tool plans and standards including the Tool-specific information in the PSAC are developed and reviewed for consistency.

c. The TQA process should provide assurance that the tool life cycle processes comply with the approved tool plans and standards including the Tool-specific information in the PSAC.

d. The TQA process should include audits of the tool development and integral processes during the tool life cycle to obtain assurance that:

  1. Tool plans and the Tool-specific information in the PSAC are available as specified in section 4.
  2.  Deviations from the tool plans and standards are detected, recorded, evaluated, tracked, and resolved
    Note: It is generally accepted that early detection of process deviations assists efficient achievement of tool life cycle process objectives
  3. Approved deviations are recorded
  4. The tool development environment has been provided as specified in the tool plans.
  5. The problem reporting, tracking, and corrective action process complies with the Tool Configuration Management Plan.
    Note: Monitoring of the activities of tool life cycle processes may be performed to provide assurance that the activities are under control.

e. The TQA process should provide assurance that the transition criteria for the tool life cycle processes have been satisfied in compliance with the approved tool plans.

f. The TQA process should provide assurance that tool life cycle data is controlled in accordance with the control categories as defined in section 7.3 and the tables of Annex A.

g. A tool conformity review should be conducted prior to the delivery of the tool product which is intended to be used by resultant software submitted as part of a certification application.

h. The TQA process should produce records of the TQA process activities (section 10.1.14), including audit results and evidence of completion of the tool conformity review for each tool product.

i. The TQA process should provide assurance that any supplier processes and outputs comply with approved tool plans and standards including the Tool-specific information in the PSAC.

8.3 Tool Conformity Review
The purpose of the tool conformity review is to obtain assurances, for a tool product, that the tool life cycle processes are complete, tool life cycle data is complete, and the Tool Executable Object Code is controlled and can be regenerated.
The tool conformity review may be supplemented or performed in the context of a software conformity review.
This review should determine that:

a. Planned tool life cycle process activities, including the generation of tool life cycle data, have been completed and records of their completion are retained.

b. Evidence exists that tool life cycle data have been produced in accordance with tool plans and standards, including the Tool-specific information in the PSAC, and is controlled in accordance with the TCM Plan.

c. Evidence exists that Tool Problem Reports have been evaluated and have their status recorded.

d. Tool requirement deviations are recorded and approved.

e. The Tool Executable Object Code can be regenerated from the archived Tool Source Code.

f. Tool Problem Reports deferred from a previous tool conformity review are re-evaluated to determine their status.

g. If certification credit is sought for the use of previously developed tools, the current tool product baseline is traceable to the previous baseline and the approved changes to that baseline.
Note: For post-qualification tool modifications, a subset of the tool conformity review activities, as justified by the significance of the change, may be performed