Starting from Zero - Corrective and Preventative Actions
1. Basic overview
The CAPA database has two main functions:
- It allows users to submit Corrective or Preventative actions
- It allows those actions to be reviewed.
Details for how to submit corrective and preventative actions are detailed on the ‘how to’ tab of the database. The information from those submissions are saved into the database for review.
This guide will focus on how to set up the database and how to use it to review submitted CAPA’s.
2. How to use the CAPA database
When first opening the database you will need to enable macros:
You will then see a menu pop-up. You will need to select the ‘Database access’ option.
The default password is ‘Noncon’, this password can be changed on the ‘Math’ tab, cell J1. Please note that the password is case sensitive. The password is the same for the example version.
Before you can properly use the database you will need to set up certain lists. The first of these can be found on the ‘Lists’ tab & are highlighted blue.
In column A you will find ‘Category’. This list is used to identify how you will categorise your CAPA’s. When users submit a CAPA they will select from this list. When you populate this list it will change the database throughout. There are example categories in place to help get you started.
In Column E you will find ‘area’, this is to detail any specific parts of your service – e.g. Clinical or admin. When entered in here they will star to appear throughout the database.
Column G can be used to detail themes used when reviewing CAPA’s. This is currently populated with some which have been used previously but can be changed as needed.
After this you can also alter the timings for how long there is for a corrective or preventative actions review to start. These are altered on the ‘KPI’ tab. There you will find something called ‘timings’. Changes here will cascade throughout the sheet.
The final part of the setup is to fill in the documents list found on the ‘docs’ tab. This is to list any local documentation used throughout your service. These are shown in the submission windows for both corrective and preventative actions.
With these steps completed the database is ready for use.
CAPA submissions can be reviewed one of two ways, either manually directly into the ‘CAPA DB’ tab or using the review window. This guide will cover both. A worked version of the database can be found within these resources.
3. Using the review window
It is recommended you use the review window as it auto-completes several fields that would otherwise require manual update.
To access the review screen, click one of the ‘Click to open review screen’ buttons on the CAPA DB tab (found in column R) – please note this is after going into admin access from the initial menu
When you open the window, the following screen will appear:
General navigation –
This screen can be navigated through tabs shown below the selection window
Or through buttons on the bottom.
View records – returns to the view record screen
Review – goes to the review screen
Concession details – goes to the concession screen
Scoring index – shown in this guide but not included in the template. This is in case you use a different scoring system. Please note the scoring index tab can be changed as needed.
Exit (buttons only) – closes the window.
View record details –
All Actions which are currently ‘New’ or ‘Under review’ will appear in the window towards the top left.
These are organised by date, going oldest first. You will see the CAPA ID, the type of action (corrective or preventative), its status (this will also show if any ‘New’ actions are overdue) and the area of service it applies to.
To view a record in detail, select it. This will now populate all of the information (where entered):
To start a review of this action, click Go to review. You can always return to this window by clicking Record details on the bottom or the tab of the same name.
When you click go to review you will see the review window:
Review screen –
It is here you will record all relevant information for the review.
The date started is auto populated once a review has been updated
Reviewer is where you record your name or initials
Incident themes are 6 drop downs to select themes from, you do not have to use all of them
Review notes is for recording any information relevant to the review
RCA is for the RCA
Action plan details is where you provide details of the action plan
If you are scoring the action, this is recorded in the score box
Final outcome should only be used when you are ready to finalise an action as complete, rejected or NA
A complete review may look like this:
Concessions –
If you need to record a concession against the action click the ‘record concession’ button at the bottom or ‘concession details’ tab below the selection window.
What is a concession?
A concession is a bit like a time extension for a non-conformance where the resolution is being worked on but will not necessarily be ready in the time frame for review. An example of this would be a document which is past its review, but its review is dependent on updated national guidance that is shortly launching. In this instance, you would raise a concession against the review date (essentially extending it) until the new guidance is launched. In short, it’s like saying ‘we acknowledge there’s a problem & need a bit longer to resolve it”.
This will take you to the concession screen.
Concession number is for the concession number to be recorded.
Concession length (days) is where you record the concessions length. When the action is saved the review start & expiry will auto-populate.
If a concession is already in place or ending you can record the outcome in the concession outcome textbox.
Once you’ve completed this click return to review
Update or complete action –
Once you have entered information you save it by clicking ‘update action’. The action now have its status changed to ‘under review’ and will continue to show in the list until it’s completed.
To finalise an action, click the drop down under ‘final outcome’ and select what the outcome is. When you update action now it will be recorded as ‘complete’.
Create report –
If a senior colleague needs to authorise an action plan a report can be created by clicking ‘create report’ on the review window. This will create a new workbook with a summary of the action and space for feedback on the action plan.
Example Report:
General –
The review screen has lots of inbuilt prompts, so if you forget to enter something important it will likely show a message box to remind you before continuing.
4. Manual review
Data from submissions goes directly into the ‘CAPA DB’ tab. The columns breakdown into several key groups:
ID &status, Record & record details, incident details, Review details, Themes, and concession details.
ID & status:
Whenever a new record is created it receives a unique ID, this can be found in column A.
Column B contains its current status, this is either ‘New’, ‘Under review’, ‘Complete’ or ‘Closed’, its really important you remember to change this status when needed (this happens automatically in the review screen).
Definition of terms
New – A new action which has not been reviewed yet
Under review – An action currently under review
Complete – An Action which has been completed i.e. RCA carried out & action plan put in place
Closed – An action closed for any other reason i.e. it may not fit the CAPA remit.
Record & Record details:
This section contains the key information about the submission. All of this information is populated from the CAPA submission.
Column C – contains the type of action – Corrective or Preventative
Column D – Shows who submitted it (unless they were anonymous)
Column E – shows the date of submission
Column F – shows whether the incident affected a patient
Column G – shows the affected patients ID number (if relevant)
Column H – shows the area of service the action applies to
Column I – shows the category of CAPA
Column J – details if the incident relates to a document/documented process
Column K – is the title of the document (where relevant)
Column L – it’s a description of what happened.
Incident details:
If the user who raised the action also raised an incident*, this is where they would provide its details.
*This refers to you Trusts own incident management systems e.g. DATIX.
Column M – shows if an incident was raised (this is a drop down)
Column N – shows the incident number.
If, following an investigation, an action has to be transferred to the Trusts incident management system the details should be recorded here.
Review details:
This section covers information detailing the review of the submitted action, its here you will record the RCA & outcome.
Column O – Contains the date the review is due to start, this is auto generated when its submitted
Column Q – This is where you record the Date it was started in DD/MM/YYYY format
Column R – The name or initials of the reviewer
Column S – Any notes relevant to the review
Column T – The RCA for the action
Column U – The action plan to resolve the action
Column V – The outcome of the review. This is a drop down list with Accepted, Rejected or NA
Column W – is the Actions score as per the CAPA scoring index
Column X – is the date the review was completed in DD/MM/YYYY format.
Please remember that once a review is completed you need to change the status in column B.
Themes:
This section provides a more detailed analysis of the Action’s themes beyond the one selected by the submitter.
Column Y provides a combination of all selected themes to allow easier filtering, column Z-AE are all drop downs listing theme options
Concession details:
During the review process there may be need to raise a concession against an action, particularly if the review is taking some time. All the relevant details are recorded here.
Column AF – is a drop down to select if there is a concession
Column AG – is where the concessions number is recorded
Column AH – is the concessions length in days
Column AI – Auto populates when the concessions review should start
Column AJ – Auto populates when the concessions expires
Column AK – is where you can record the concessions outcome.
This covers all sections for manual entry of information.
A note on timeframes:
The CAPA tool contains formula and formatting aligned with the following timeframes
- Corrective actions show as overdue if a review is not started within 28 days of being raised
- Preventative actions show as overdue if a review is not started within 84 days of being raised
4.1 Colour Key
The CAPADB tab has some conditional formatting to help highlight certain things:
*there may be instances where a review cannot be completed due to unforeseen consequences and needs to be closed.
5. Other sheets in the database
KPI’s
The KPI’s tab provides a comprehensive breakdown of Corrective and Preventative actions by category and theme across areas of the service as well as showing current performance measures such as how long it takes for reviews to be started and how long it takes them to be completed.
Reports
This tab can be used to generate a report of key CAPA information across a set time frame. Enter the start and End date into the light blue cells then click ‘create report’ this will generate a new spread sheet with the information.
Lists
This tab should mostly be left alone. However, Themes can be updated here. The themes are in column G and should only be entered in the light blue cells. Anything outside that will not be detected
Docs
This is where you record the titles of documentation used in the service. Document titles should be entered in the light blue cells. This populates the documents list used when submitting a CAPA.
Math
Best to leave this one alone.
General note:
This database has been left ‘open’ for you to adapt as you see fit, however, certain processes will cease to work if you move/delete parts of it, it will likely stop other parts functioning. The user screens in particular are set to populate set rows/columns and do not automatically shift to any changes.
The CAPA database is set to auto save itself on closure.