A Design History File Index is a summary of the deliverables (most often documents) that makes up the Design History File. It includes information such as the title, version and location of each deliverable.
Furthermore, it is common that the company Quality Management System (QMS) defines required deliverable state at specific project phases. For example, the QMS might require that the DHF contains a "Product Requirements Document" and that this deliverable must be available as draft at Milestone 2 but released at Milestone 3.
Normally, the QMS provides a DHF Index Document Template, that specifies:
The deliverables of the DHF (e.g. Product Requirement Document, Master Test Plan, Risk Management Plan).
At which Project Phase each deliverable must be available in which state. (e.g. PRD must exist as (at least) draft at M2 but must be released at M3)
The Project then fills out this template with the concrete deliverables.
The Aligned Elements DHF Index has been built to reflect this behaviour.
In the Project Explorer, navigate to the DHF Line Item section. Create a DHF Line Item.
In the title of the DHF Line Item, write the name of the deliverable (e.g. Product Requirement Document or Risk Management Plan).
A DHF Line Item is a Document Object and therefore can be used as all other Document Object Types i.e. traced, updated, checked for inconsistencies etc. Just like for any other Document Object you can use Chapters to group the objects.
We recommend that you use the top level Chapters to group which DHF Line Items that belong to which Project Phase. This grouping will later be displayed in the DHF Index.
Define the required status of the document object according to the QMS. In the Status Per Phase data grid, specify the required status of the document in each phase according to your QMS. Use the Plus buttons to add rows.
The control assumes that the entered status is applicable for all phases up to entered phase. For example, if you enter only one row with the Phase “M3” and the Status “Draft” it is implied that “Draft” is the only valid state for all the phases “M1”, “M2” and “M3” but not for “M4”.
Consequently, if you enter only one row with the Phase “M3” and the Status “Release” it is implied that “Release” is the only valid state for all the phases “M1”, “M2” and “M3”.
This can be somewhat confusing. Therefore, you should always enter at least two rows in this table with adjacent phases. In the case above, the correct way is to enter one row with Phase “M2” Status “Draft” and a second row with Phase “M3” Status “Release”.
If you have a Document (Word) Template for the deliverable (e.g. a Product Requirement Document template) you can add it using the Template File Attribute.
Up until now we have defined what the Design History File should contain, i.e. which deliveries that must be included and the "status to phase" rules according to the QMS.
The next step is to define what the Design History File actually contains at this given point in time.
A DHF Line Item may point to documentation within Aligned Elements (Internal mode) or to documents stored outside Aligned Elements (External mode). The applicability is defined in the attribute Mode.
If the mode is set to External, you shall specify the name of the concrete deliverable that fulfils this required deliverable. This is done in the attribute "Fulfilled by External References". If this attribute is empty, the DHF Line Item is considered inconsistent.
The Document Version and the Current Status of the document must be set manually using the available Status and Version attributes.
For the Internal mode, normal traces define which document objects that fulfil the deliverable. You may use one DHF line Item and trace to any number of document objects.
If no trace is set, the DHF Line Item is considered inconsistent.
If the File Object has a status attribute, then this status overrides the Current Status attribute in the DHF Line Item. The mapping of statuses can be done in the DHFStateToPhase validation rule.
If the File Object has a version, then this version overrides the Document Version attribute in the DHF Line Item.
Your project might not apply all documents defines by the QMS. For example, the QMS might require a document called "Electrical Wiring Plan". If you are working on a software project it does not make sense to include this document. In such a case you can set the mode to N/A ("Not Applicable") to explicitly declare that you intend to skip this document in your DHF. You are required to write a qualified reason in the attribute "Qualification for N/A" for a N/A item to be consistent.
The following convention should be used:
For DHF Line Items in internal mode, you may use one DHF line Item and trace to any number of document objects.
For DHF Line Items in external mode, you should create one DHF Line Item for each external document to be able to track the individual version and status of the document. 3
If you are using Signatures in your project, you may extend the DHFLineItem template with a table where the default users that should sign this type of document including their role can be listed. Please contact firstname.lastname@example.org for configuration assistance.
To track external documentation in Aligned Elements:
Open the applicable DHF Line Item (or create a copy of an existing DHF Line Item) and set the mode to External.
Type the name of the document in the attribute Fulfilled by external References and the file path in Hardcopy Location.
In the Navigation Bar, select DHF Index. In the next dialog you can select the DHF Index view mode.
The first option shows you the current state of your DHF Index.
The second option displays the most recent release version of Documents which primarily makes sense when using e-signed documents in the DHF Index.
The third options is similar to the second but also shows all revisions of the Documents that have been released as opposed to the most recently released revision.
A fully released document means that the document has a completed signature object with the sign status set to “closed”.
If such documents exist in your project history, that revision of the document will be displayed.
Once the DHF Index has been displayed, each column represents an attribute in the DHF Line Item or the underlying Document Objects.