Control of Software Checklist




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ASQR 07.5

Control of Software - Checklist



#

Par #

Requirement

S

CAR

N/A

Comment









Non-deliverable Software














1

4.1

Does the supplier have a defined, documented and implemented non-deliverable software control procedure(s)? Does it define the minimum types of software, as outlined in the “Non–Deliverable Software Definition”?













2

4.1.1

Does the procedure define the organizational responsibility and authority including product and process integrity?













3

4.1.2

Does the procedure define the software “identification requirements”.

- Defining the purpose or function of the software.

- Defining the requirements and how the software requirements are initiated, documented and approved.














4

4.1.3

Does the procedure define the software “coding standards”:

- Naming conventions, including developmental version production file names.

- Software Version

- Header information

- Comments














5

4.1.4

Does the procedure define the “verification & validation” of the software:

- Defining the Verification and Validation process.

- Including the test procedure or test description and that results shall be documented, reviewed and retained.

- Provide objective evidence that the software performs its required function.

- Trace software to requirements.

- Require that someone acting in an acknowledged product integrity role must perform the inspection review and approval of software. That software used to verify quantitative values (e.g., CMM, etc.) requires an independent method of validation (i.e., layout inspection, fixture check or comparison with another CMM program previously verified by an independent method) and correlation of the two sets of results.

- Acceptable correlation requires the difference to be within 10% of the tolerance for each characteristic. Differences greater than 10% but not exceeding 25% may be acceptable with documented justification.

Differences greater than 25% are not acceptable.


















6

4.1.5

Does the procedure define the “target environment” and:

- Identify interfaces to other software and to target computer hardware.

- Identify the target computer hardware and software environment.














7

4.1.6

Does the procedure define “version control” and:

- Uniquely identify each version of the software.

- Identify each item that makes up a software product.














8

4.1.7

Does the procedure define “change control” and define the software change process. This includes, but is not limited to:

- Identifying problems.

- Analysis for problem cause.

- Implementation and verification of corrective action

- Re–verification and re–validation of software shall be employed to ensure that the modified software meets the changed requirements.














9

4.1.8

Does the procedure define “access control” and ensure:

- Limited access control shall be defined and implemented.

Examples of such controls include:

a)Read and write access of the master and copies.

b)Edit Key restrictions (e.g. NC, CNC Machine, etc.).














10

4.1.9

Does the procedure define “archiving, backup & recovery” and:

- Define the process used to prevent the use of obsolete software programs.


Software that is no longer required for production shall be restricted and/or removed from all systems so it is no longer available for use.

- Master copies, duplicates, and user copies shall be restricted and/or removed from all areas except the archive.

- Obsolete software in the archive shall have restricted access to prevent unauthorized use.

- Master copies shall be stored in a secure location.


- Software programs shall be archived in a manner that allows retrieval of all released versions of software programs for traceability purposes.













11

4.1.10

Does the procedure define “identification, storage, handling & release” and:

Define the method for identification, storage, handling and release of software to the user. The end user shall only access the latest software program version.















12

4.1.11

Does the procedure define “training & maintenance requirements”?












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