A manufacturer’s quality manual is often referred to as the ‘quality Bible’ of the business and the phrase is apt enough in some ways: the manual is an ultimate source of authority, and every factory has one. However, as a document, it often is somewhat inaccessible and if not, downright intimidating to many factory workers.
Quality manuals should be living and breathing documents. They are not set in stone but should be in constant dialogue with the realities of the factory floor, amended, versioned, and inspected almost as if the manual itself was also a process. Ultimately, you want everyone to like your quality manual as you would appreciate and like any tool that helps you do a better job at improving quality performance.
This article presents how to manage your quality manual in AlisQI.
In this article
Let's start with a two minute introduction video of the AlisQI Document Management functionality.
A controlled document is a document that must undergo formal review, formal approval, controlled distribution, controlled modification, and controlled storage and access. AlisQI facilitates all of this for you. Any document uploaded in the AlisQI DMS is controlled by definition. There is no way to circumvent the control mechanisms.
Result attachments are not controlled documents. They can be added and removed without formal approval, but are subject to permission management (this is derived from the analysis set Read permission).
A requirement in quality norm systems is for documents to remain legible and readily identifiable. This normally involves a reference code or numbering system and a standard document format. AlisQI gives you full control over the numbering of your documents. There is no predefined numbering system, you can import all your existing documents with their current numbers and start from there.
Best practices in document numbering
Choosing a document control numbering system may seem challenging when faced with a number of different types of documents. There are no requirements in the ISO 9001 standard for document labeling, only that each document is easily identifiable.
Type of document can be differentiated by a prefix, such as "SOP-" for a standard operating procedure, "POL-" for a policy and so on. Numbering can be done either sequentially as created or using a numbering system in which each digit represents something. For example, SOP-PRO-006 could mean the sixth standard operating procedure within the department designated as PRO (Production).
On document publication, AlisQI automatically adds the publication date, owner and version number to the document. Read all about versioning here.
Documents in the AlisQI DMS can only be edited by the document owner, document delegate, or others with explicit document management permissions.
Every user can suggest a document modification, but that first step is only considered a suggestion by the document owner. Please refer to the document modification flow chart to see the full flow.
Read all about document modifications in this article.
All changes to documents are recorded in a per-document audit trail. These trails provide the who, when, what answer for all changes. Read all about audit trails here.
Automatic expiry notifications
For every document, we record a revision term. This defines how often the document is presented to the document owner to assess its validity. The document owner will be notified that the document is due to expire one month before the expiration date. This counter resets after every change of the document.
The default revision term for documents is 12 months.
The AlisQI DMS allows you to upload basically any file formal except for application files or videos. For videos, we suggest using a dedicated video platform like YouTube or Vimeo and linking them from your flow charts.
We strongly advise using MS Word files (in .docx format) as they can be edited right away in your desktop Word client.
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Uploading a new document
New documents are uploaded in the document overview. Click "+ New document" or simply drag and drop a document from your PC to a folder.
After selecting the file, a panel will appear where you can specify document properties like the owner and revision period.
We recommend uploading Word files (.docx) as they can be edited directly from the app. The in-app document viewer will convert Word files to PDF to ensure they are immutable.
Currently, there is no mechanism to approve new documents, they are considered approved right after uploading.
Import an entire quality manual
When starting with AlisQI, you most likely already have a full repository of documents in your current quality manual. We can assist you with uploading all your current documents and folder structure in one go.
For that bulk import, we advise you to create a ZIP file containing the folder and documents and reach out to firstname.lastname@example.org to discuss secure file transfer.
The document tree is unlimited in its nesting. Add as many levels as you need.
Add subfolders by clicking on the + icon of a parent folder.
The Root level is always present. Your first level of folders will be added as children of the Root.
The Root level cannot be deleted or renamed.
Changing documents can be done in two ways. Small changes can be performed without the formal modification and approval flow, whereas more fundamental changes will require this formal flow.
Any change will be recorded in the audit trail. There is no way to circumvent this.
Modification and approval flow
For more fundamental changes to documents, AlisQI offers a formal modification and approval flow.
Any document reader can initiate a modification. The document owner and delegate will work on a new draft version of the document, inviting others in the organization to collaborate on that draft. When they are done and have a new version to be published, they will request publication with the caresystem administrator. This role will have the final verdict in the publication. Only when the caresystem administrator approves, will the new version be published. The old version is archived and the audit trail is updated.
Desktop Word client editing
AlisQI integrates seamlessly with your desktop Word client. When editing a document, there is no need for manual downloading and uploading. Just open a document for direct editing. Your Word client will be loaded, and changes you make to the document will be automatically sent to AlisQI.
All the built-in edit, comment, and track changes features of Word work in this direct edit mode. So, don't hesitate to use them, as they are of great value in collaborative document editing.
Watch this video below to learn about the clever Document Management features AlisQI offers.
Desktop Word client integration currently only works with Chrome, Edge and Safari. Firefox does not support this integration.
When a new version of a document is published, the old version is archived and all links refer to this new version. Furthermore, the organization will be notified of this new version. In order to only notify those involved with this document, there is a notification list per document. This notification list is a list of user groups. All users in the groups on the notification list will receive a message that a new version has been published.
When there is no explicit notification list, all users with read permission will receive a notification on the publication of a new version.
The AlisQI DMS has a set of predefined user roles.
The document owner is the formal owner of a document. They can modify their own documents.
The delegate technically has the same capabilities as the document owner, but they lack the formal ownership of a document. This means they can operate as the owner, without being the formal owner.
Any team member can be invited to join a document modification and collaborate in reviewing or editing the (draft) document.
The caresystem administrator is defined under Application settings.
In an upcoming release, the caresystem administrator will be replaced with an approval committee that can be configured per document. Stay tuned for product updates.
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Automating your Document Management significantly speeds things up, but the big advantage of an omnipresent quality management system might be new to you.
The version number of a controlled document accounts for the two types of changes one can do to a document:
- Changes to document content
Only changes to the content or body of a document
- Changes to document meta properties
Like owner, revision term, reconfirmation term, …
In the version number, we explicitly distinguish between these two types of changes. More specifically, AlisQI will mark every document with a version number that will be structured as ‘x.y’, where x represents the major version and y the minor version.
Changes to the document itself (1) will lead to a new major version number, while changes to meta properties (2) will lead to a new minor version number.
Word files are automatically converted to PDF in the in-app document viewer. This makes the files immutable. Furthermore, this allows for automated versioning of the documents.
Document owners can always download the raw (.docx) version of the files.
In the in-app document viewer, documents are enriched with automatic version information. A header is added to every document showing title, owner, and version properties. This header is added to the PDF and present in PDF downloads as well.
There is no way to circumvent this versioning in the in-app document viewer.
There is a reason why you maintain your quality manual: it's to be used by your organization. And you want these documents to be easily accessible. That's why AlisQI enables you to link documents to the forms and flowcharts. This way the documents pop up right there where you would need them.
The visualize feature provides you with an overview of the links between documents, analysis sets and models.
To link documents to forms, navigate to the Results overview and click More » Documents. This UI enables you to link documents to fields or the entire set.
The linked documents will appear in the Results overview and data entry screens.
Presenting all relevant documents per process step is one of the key features of the flow charts in AlisQI. Read all about linking documents to flow charts here.
Every document has its own permanent link. This links directly to the current version of the document stored in AlisQI. You can use this to create deep links to your documents from external applications or documents.
Retrieve the permanent link from the active assignments panel. This is accessible by clicking on the chain icon in the Document overview.