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Chapter 2: Quality Assurance and Configuration Management Data Package (manufacturer)

This section contains requirements on the content of the quality assurance and configuration management documentation that manufacturers must supply to the certification authority.

2.1 Quality and Configuration Management Manual

2.1-A Develop and present

All voting system manufacturers SHALL develop and present to the certification authority a complete Quality and Configuration Management Manual.

Applies To: Voting system

Source: New requirement

2.1-A.1 Processes and procedures

The Manual SHALL detail the manufacturer's Quality Assurance and Configuration Management processes and procedures required by the VVSG. These processes and procedures SHALL conform to all requirements of the VVSG and the standards listed in Requirement Part 1: 6.4.2.1-A.

Applies To: Voting system

Source: New requirement

2.1-A.2 A binding commitment

The Manual SHALL declare that meeting the requirements of the entire VVSG is a binding commitment for the entire manufacturer organization.

Applies To: Voting system

Source: New requirement

2.1-A.3 Project plan

The Manual SHALL provide for the formulation of a project plan for the design and development of a voting system. It SHALL require the project plan to be clearly and unambiguously documented.

Applies To: Voting system

DISCUSSION

The project plan should be consistent with the Design and Development Planning requirements, as specified in ISO 9001:2000, Quality management systems – Requirements [ISO00] Section 8.3.1.

Source: New requirement

2.1-A.4 Quality check

The Manual SHALL require the project plan to include, at a minimum, one quality check at the end of the design phase, and one quality check at the end of the development phase. The project plan SHALL define the progress that is required before each quality check can be passed.

Applies To: Voting system

DISCUSSION

A "quality check" is the sum of the activities Design and Development Review, Design and Development Verification, and Design and Development Validation, as defined in [ISO00] Sections 7.3.4. through 7.3.6.

Source: New requirement

2.1-A.5 Problem log

The Manual SHALL require the manufacturer to maintain a log in which all difficulties encountered during the design and development phase for a voting system are required to be recorded. Any remedial action taken to correct a difficulty SHALL also be recorded. The log SHALL be available for inspection by the test lab.

Applies To: Voting system

DISCUSSION

"Difficulties" are any occasions when it is recognized that changes in past design decisions or in the project plan (see Requirement Part 2: 2.1-A.3) are necessary to complete the project.

Source: New requirement

2.1-A.6 Critical parts, components, and assemblies

The Manual SHALL specify rules that define what parts, components, and assemblies of the voting system are to be considered as critical. A part, component, or assembly SHALL be defined as critical if its failure may:

  1. Cause a faulty display of options;
  2. Cause an uncertainty if voter's choice has been recorded;
  3. Cause a false recording of vote cast;
  4. Cause the change of stored votes;
  5. Cause the false transmission for polling station totals;
  6. Cause injury to voters or staff;
  7. Provide an opening for tampering;
  8. Violate a voter's privacy;
  9. Cause a false accumulation of polling station totals;
  10. Cause a false transmission for regional totals;
  11. Give the appearance of irregularity;
  12. Violate a voter's ability to vote independently; and
  13. Impede the usability of the polling station for all voters.

As used here, "components" include software modules.

Applies To: Voting system

Source: New requirement

2.1-A.7 Testing statements for every part, component, and assembly

The Manual SHALL require that the design and development process of a voting system produce statements for every part, component, and assembly, whether to be manufactured by the manufacturer or obtained elsewhere, that impacts conformity to the VVSG. These statements SHALL define verifiable requirements against which the part, component, or assembly can be tested at the end of its manufacturing process, or upon delivery, as appropriate. The requirements SHALL be defined in such a way that any part, component, or assembly that meets the requirements will provide the functionality and reliability required of it for the voting system to meet the overall functionality and reliability requirements specified in the VVSG.

Applies To: Voting system

Source: New requirement

2.1-A.8 Inspection processes for every part, component, and assembly

The Manual SHALL require that the design and development process define or identify processes by which all parts, components, and assemblies of a voting system can be tested for compliance with requirements developed under Requirement Part 2: 2.1-A.7.

Applies To: Voting system

Source: New requirement

2.1-A.9 Testing statements for the entire voting system

The Manual SHALL require that the design and development process of a voting system produce a statement that defines verifiable requirements against which any voting system can be tested at the end of its manufacturing and assembly process in such a way that passing the test provides assurance that the voting system meets all requirements defined in the VVSG.

Applies To: Voting system

Source: New requirement

2.1-A.10 Inspection of all purchased parts, components, and assemblies

The Manual SHALL require that all purchased parts, components and assemblies are tested according to the testing requirements developed under Requirement Part 2: 2.1-A.7 and the processes developed under Requirement Part 2: 2.1-A.8 before they are incorporated into a voting system. The records SHALL be maintained until such time as the certification of the voting system model expires or is revoked.

Applies To: Voting system

Source: New requirement

2.1-A.11 Inspection of all manufactured parts, components, and assemblies

The Manual SHALL require that all manufactured parts, components, and assemblies are tested according to the testing requirements developed under Requirement Part 2: 2.1-A.7 and the processes developed under Requirement Part 2: 2.1-A.8 before they are incorporated into a voting system. The records shall be maintained until such time as the certification of the voting system model expires or is revoked.

Applies To: Voting system

Source: New requirement

2.1-A.12 Records of all critical parts, components, and assemblies

The Manual SHALL require that for each part, component, or assembly, whether purchased or manufactured by the manufacturer, that has been defined as critical (Requirement Part 2: 2.1-A.6), records SHALL be kept that document the complete history of the part, component, or assembly. The records SHALL include:

  1. The source of raw materials;
  2. The processes used in the manufacture;
  3. The time when critical manufacturing steps were taken;
  4. The organization or person that performed each critical manufacturing step, and
  5. The persons who performed the required inspections.

The records SHALL also include documentation of:

  1. Any failures, discrepancies or anomalies that might have occurred during manufacture;
  2. Any actions taken to correct the failure, discrepancy or anomaly; and
  3. The final determination that the problem has been corrected.

These records shall be available for inspection.

Applies To: Voting system

Source: New requirement

2.1-A.13 Technical capability for monitoring

The Manual SHALL require the manufacturer to identify and maintain the technical capability to monitor the in-service performance of each voting system sold throughout the life cycle of the voting system's model.

Applies To: Voting system

DISCUSSION

For the purpose of this and subsequent requirements in this section, the term life cycle of a voting system model is defined as the time period from the delivery of the first voting system of that model to the time when the certification of the model expires or is revoked.

Source: New requirement

2.1-A.14 Technical capability for developing and implementing remedies

The Manual SHALL require the manufacturer to identify and maintain the technical capability to develop and implement remedies that are suitable to correct any defects that lead to in-service difficulties in all voting systems sold, throughout the life cycle of the voting system model.

Applies To: Voting system

Source: New requirement

2.1-A.15 Financial capability to provide the product support

The Manual SHALL require the manufacturer to identify and maintain the financial capability to provide product support, as defined in Requirements Part 2: 2.1-A.13 and Part 2: 2.1-A.14, throughout the life cycle of the voting system model.

Applies To: Voting system

Source: New requirement