These preferences are OU specific and affect only the records found within the OU selected. This makes each OU semi-autonomous, as these settings allow it to govern itself.
This section allows selecting who should be informed when an external change control request is submitted to their OU. It also allows defining a list of users who will be tasked with performing the triage of the incoming request. Once one of the users completes the triage, the tasks become invalid for the rest of the triage team.
There are also some security settings for the PDF copies of any printed change control projects.
To set up the users responsible for receiving new Change Control requests in a given OU:
and then, to select the triage team:
The Triage Team (Triage Users) is only responsible for new Change Control requests submitted to its OU.
When a new form is submitted all members of the triage team will be tasked to triage the change control request. Only one person may actually perform the triage and once completed, any tasks for other team members will be automatically invalidated.
It is not necessary to set up a triage team. Any user with permission to edit change control records (in the record’s OU) can triage new records, they just will not receive ‘Change Control Triage’ tasks when new requests are submitted.
The cover pages setting allows a user to link existing cover page PDF documents. These are added to the system through the Cover Pages sub-menu option, found within the Administration -> Cover Pages.
The OU should be selected from the Organisation Unit drop down menu at the top of the page. Once this is selected, select the cover page to be used for each of the documents. Each record can have their own cover page.
There are some important preferences within this setting.
Allow Document Owners to perform any action on their documents, regardless of permissions - ships checked by default so that document owners can even authorise their own documents. If this option is unchecked, document owners will only have the permissions they have already been granted through user group membership in the OU and for the type of document they own.
Allow minor change for that OU - allows admin to determine whether the OU is to allow Document Correction or not. With this active/checked, it is possible for users with suitable permissions to make adjustments to authorised controlled documents without having to create a new version. This preference controls ‘Document Correction’ for all controlled documents.
Allow uncontrolled prints of… - This series of preferences allows admin to print ‘forms’ from each of the controlled document types. With this preference active/checked, a user can select that the print does not need to be recovered should a new version be created. This allows a user to print documents that would not normally be destroyed should a new version be created.
When the settings to allow uncontrolled prints are enabled, a checkbox becomes available in the print/download lightboxes (within that particular OU):
Controlled Prints - Prevent editing of the PDF - Downloaded PDFs will carry settings to prevent them from being edited
Controlled Prints - Prevent form filling or annotations of the PDF - Downloaded PDFs will carry settings to prevent the ability to complete forms contained within them or adding annotations with a PDF editor
Controlled Prints - Prevent printing or copying the contents of the PDF - Downloaded PDFs will carry settings to prevent content being copied from them
Disable Preview printing - allows admin to choose whether users can print the controlled document PDFs they are previewing or not.
Disable verification step for the document reviews - allows admin to choose if the verification step is required when performing a peer review within the selected OU. Activating this preference removes the verification step, so that when a peer review has been accepted or rejected by the author, the workflow closes.
Enable Controlled Print Flag by Default When Downloading Files Without a Preview - If the preferences above, “Allow uncontrolled prints of…” are enabled, the default setting of the option, “This download should be controlled” can be toggled here. The option to control downloads so they can be tracked, appears when downloading files that can’t be previewed online, as shown in the image above.
Pin and Signature required for authorising…. - This series of preferences allows admin to determine whether a separate PIN is required when authorising any of the controlled document types. If this is active/checked, then a user is required to enter their PIN (set in: My Profile > Change Password or PIN) when attempting to authorise the controlled document. Until a PIN is entered that matches the one stored with the user, the document cannot be authorised.
Setting a PIN in the My Profile area:
Navigate to My Profile (link in left side bar) and click the tab Change Password or Pin
Document Control Preferences in an OU named, Vaccine Centre:
When making a change to any of these preferences it is important to remember to scroll down and click Save.
These are OU specific options so if a user chooses to enable them for their OU, other OUs will not be affected.
The document review settings allow administrators to determine when a document’s review cycle should start in relation to its review due date. The default is for review tasks to be issued 30 days before the review is due.
The notifications themselves can be received as either a Daily Reminder, a Weekly Reminder, a Daily Summary and a Weekly Summary email, with this being chosen within the Profile -> Preferences Tab of iPassport QMS.
To change the values on the ‘Document Review Settings’ page click the relevant field and type the new number of days notice required.
The Index Generation settings page allows admin to design their own index ‘recipe’ for records that offer automatic index generation. The variety of records included can be viewed in the image below.
The automatic index generation process is applied by default when the manual option is ignored at the time the record is being created.
An index is automatically prepared but a user can choose to override the system’s index by clicking the cog icon (next to the Index field in the record creation page) and entering a different index.
In all cases, each index has to be unique across all OUs and the system will validate it before allowing it.
A manually created index can be replaced with a system generated index, as long as the record can still be edited and a pencil icon shows next to the index field.
To add a system generated index:
A new index, prepared with the recipe set in this section, should display.
An index can be built by combining variables with static text.
The following variables are available:
|%day||the current day|
|%month||the current month|
|%year||the current year|
|%id*||the number of the record (generated by the system)|
|%ou||the name of the Organisational Unit that contains the record|
These options can be used with controlled documents:
|%section||the document’s section|
|%category||the document’s category|
* The number (%id) is generated sequentially in each OU but as each index has to be unique, the system will go up in increments of “1”, until a valid index is obtained. Numbers can be repeated across OUs as long as the index as a whole is different from indices that use the same number. Please see additional information in the section, Index ID Settings.
Any static text can be used in conjunction with variables. However, there is a total limit of 255 characters for any generated index.
Here are some examples of recipes and what the index could look like:
|Index recipe||Example Index Generated|
|%year-%month-%day Incident-%id||2020-02-20 Incident-36|
|%ou %id||BIO 37|
If a non compliance is entered via the external form then a notification will be set to the distribution list selected.
Should the verification step be active (see Disable verification step for the document reviews) within the peer review process, then the management list (Distribution list) selected in the Review Feedback preference would be sent details of the peer review(s) for the selected controlled documents.
A distribution list needs to be created within that area of the system: Laboratory Management -> Distributions Lists -> New Distribution List and needs to have the List Type of ‘Review Verifier’.
Every Organisational Unit can have it’s own Risk Assessment matrix, based on a customisable set of ‘Risk Consequences’ and ‘Risk Likelihoods’. The matrix is added to every new Change Control request, where Risk Scores are then calculated by either adding or multiplying (according to user preferences) the consequence and likelihood values selected.
The ‘Risk Assessments Setings’ page has some basic settings in the top section, a middle section to enter all the parameters and a bottom section where you can preview what the risk matrix will look like.
The names, ‘Risk Consequence’ and ‘Risk Likelihood’ can be changed as required in the fields provided.
Please note that the terms, Risk Impact and Risk Mitigation are used in other fields.
The Save button must be clicked before navigating away from the page or changes will be lost.
Any changes made will only apply to new change control records. A snapshot of the risk matrix is taken when the record is created so the matrix can’t be changed on an existing change control record.
Default labels and values are provided for each OU to have a starting point in case any Change Control requests are created before the risk assessment settings are configured. These can be edited to suit the requirements of each department.
The risk matrix consists of a set of Risk Consequence levels laid out horizontally (x-axis) against a set of Risk Likelihood levels stacked up vertically (y-axis). The largest value of each of these is used to calculate the maximum Risk Score.
For example, if the highest Risk Consequence and Risk Likelihood values are set to “10” and addition is selected, the highest Risk Score will have to be “20”; if multiplication is selected, the highest Risk Score will have to be set to “100”.
The Risk Matrix in a Change Control Record
The risk consequences and likelihoods created in this section are selectable from a dropdown menu in the Change Control forms; the system calculates the Risk Score by adding or multiplying them.
Both the risk consequences and risk likelihoods should be set in bands, spreading the scores across the range of risks. The names, scores and colour of each band can be edited and previewed until the desired matrix is accomplished.
To configure Risk Consequence Scores and Risk Risk Likelihood Scores:
To configure the Risk Score, the same steps apply but some calculation is required:
When the parameters have been edited, the risk matrix can be redrawn by clicking the 🔄refresh button above it, on the right.
The skilled task setting page contains a number of items that relate to the whole skilled process.
‘Issue new Task for re-issued skills’ This creates new tasks when a skilled task is re-issued; this in turn invalidates the existing task. If this option is not selected then the system simply sends a reminder to the user when a skilled event is re-issued.
‘Reissue skilled tasks only on Major revision’ This option allows admin to choose when to send a new task out, by default this item is not selected which means iPassport sends a new skilled task for each document revision be that major or minor. With the option selected iPassport only automatically issues a new skilled task on major revisions but provides a choice to send them on each minor revision.
‘Require verification of skills from user with tasks’ When activated for the OU this requires that all skilled task events created with a task should be verified via the skill management area. This option applies to all controlled documents with associated skills within the OU.
‘Require verification of skills from user without tasks’ When activated this requires the verification of all skills marked as completed that were not created via a skilled task. As such this only refers to those skill events created as Trained (not issuing a task). This task does not control the normal skilled task process. It can be used whenever a staff member is signed off as trained to add supporting evidence if needed.
‘Set skilled tasks’ due date to be the same as a release date if document is Pending Release’ This option works in conjunction with the pending release feature/ delayed release which allows all skilled tasks associated with it to have their due date set as the date of the release of the controlled document. This is especially useful if trying to keep track of staff that completed the skilled task on time.
‘Skill Verification Summary Email’ determines how often verifiers will receive reminders of outstanding verifications.
‘Time interval for Due Date on system reissued skilled tasks’ When a skilled task is sent by the system as part of the automatic reissue interval it is possible to set the Due Date of this which is the number of days after issue when it should be completed.
‘Time interval for reissuing skilled tasks for … document type’ This allows the system to operate independently. Setting an automatic reissue interval means that if no changes occur (new versions) and no compulsory reviews happen, iPassport will automatically contact the users on the list again with a new skilled task. This is set as a day countdown. For example, if the time interval is set at 365d this means that 365 days after the skill was completed, if no further action is taken, iPassport will send another task in 365 days. If after say 360 days the document is reviewed and a new version created iPassport simply starts is countdown again.
The Standards settings allows admin to choose what standard statuses are available for use within their iPassport QMS. If all options were activated then admin would be able to assign any one of them to a standard. Should they be deactivated, then that status would not be available for selection. Any setting(s) that is deactivated are also not visible within the list of standards, but any set before the change can be found in the standard search.
This is an OU specific option, which allows OUs to manage their own standards without complications.
The summary setting allows a user (only one per OU) to receive a summary email on a daily basis of all task activity within the selected OU. In order to receive this email, an email address needs to be added into the ‘Email address to send summary to’ field and the ‘Send daily summary via email of tasks for this department’ field needs to be activated/checked.
The combined Watermark Preferences cover each type of controlled document on the system; the example used here is for SOPs.
The watermark preference allows admin to customise the watermarks used on a controlled document type within a given OU. This overrides any default watermarks set under System Preferences > Default Watermarks.
It is important to note that it is not possible to include images within the watermarks.
The watermark preferences cover the following scenarios:
- Footer Information
- Spine Information
- Footer Information
- Spine Information
- Footer Information
- Spine Information
Each of these three scenarios is used for each controlled document status e.g. Draft, Authorised, and for each controlled document type e.g. SOP, Policy.
Key users can be set to be notified when staff under their supervision have overdue tasks. Different users can be appointed for different types of tasks. The time between the task becoming overdue and then escalated can be set separately for each type of task too. For details, please refer to the user guide, Task Escalation Settings.
The Index ID Settings page allows admin to input the value they would like each type of record’s index number to start counting from. By default, the system automatically generates an index for every new document, following the rules set in the Index Generation section. If the variable, %id is used there, a sequential number will be assigned in the index. This number will normally start counting from “1” but a different starting number can be declared in this section.
A user can choose to add a different index manually, by clicking on the cog icon next to the index field in the record creation page. In this case and also when an index is automatically generated, the system will check that it hasn’t already been used. When it’s automatically generated and the number has already been used, the system will try to assign the next number up, in increments of “1”.
The counter works independently for every OU but every index has to be unique in the whole account. It’s therefore recommended that the index generation ‘recipe’ includes a differentiating variable, like %ou.
As an example, suppose an account has the two OUs, Biochemistry (BIO) and Virology (VIR):