Management Reviews are held to ensure the quality management system’s continuing suitability, adequacy, and effectiveness. The reviews are a look back and forward; review action items from the last management review, assess flagged opportunities for improvement and discuss future changes to the quality management system including the quality policy and objectives. The management review process helps drive continuous improvement and business benefits.
Is your Management Review Process adding value?
Qualio is here to help as your eQMS platform but also to help with ideas to get started.
Let’s understand ‘What’s happening in a Management Review meetings’, you can watch the below webinar recording.
NOTE: The structure and complexity of your company should be considered as you define appropriate management review mechanisms as required by ICH Q10, ISO 13485, and FDA QSR 21 CFR 820.
(Recorded 11/30/2022. Runtime 45:22)
How to Prepare for a Management Review
Start to prepare as early as possible. You’ll need time to collect data/information for your Management review and to schedule the review on calendars with plenty of advanced notice.
If you’ve performed Management Reviews previously, you’ll want to reference the last meeting minutes and action items. If those action items haven’t yet been completed, reach out to the action owner to nudge them to complete or update the task status before the next review.
Whether it’s your first management review or your 100th, you’ll still want to review or create a Management Review procedure document. This is discussed during our webinar. You’ll want to detail items in your procedure for scheduling, conducting, and recording Management Reviews of the quality management system, such as management review inputs and outcome of the meeting. If you would like assistance with creating procedure documents like this, Qualio Plus services help customers with professional quality advice and we also have templates we can share. Learn more about Qualio Plus services here.
Analyze reports and data to review
Data visualization is an art form and highly effective in situations like a Management Review. Use exported data from Qualio to create charts and graphs in your presentation to show trends, spikes, and intriguing insights that would otherwise be hidden in rows of text.
Here are some quick links on how to export or leverage data in Qualio for different features:
Example Data Visualizations
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How to Use Qualio for Management Reviews
A document template can be created in Qualio and used to record your management review meeting agenda, minutes of the meeting, and action items. By using a Qualio document, you're not only taking steps to build out your document library for all Quality related documents, but you will also have a consistent document structure to match your Management Review Procedure. Also, you can also easily leverage the smartlink feature to link to other documents and events. To get a head start on creating a Management Review document template, click the button below and download the sample template.
We also advise that you build an event template where you will assign the management review action items to individual team members. Hint: link these action items from the Event to the Management Review Minutes and Action Items Document. You will also be able to monitor the action items and track to completion if you follow this suggestion and create a task for each action item. Click below to download the event template.
Management Review Tips & Tricks
Senior leadership support and engagement is critical for success of the management review process.
Identify the Management Representative (MR) from the team / resources that you have. Ensure the MR is from the Senior leadership/Quality/Senior employee able to take the MR role.
Promote a Culture of Quality in your organization by inviting the entire company. We do this at Qualio. Our employees really appreciate the transparency and education they can share with their customers.
Make it fun. We choose a different theme for each Management Review. The last theme was Star Wars. Other ideas: Lord of the Rings, Dilbert, Marvel or DC comics, Mad Men, gemstones, memories of the 80’s, mad hatter tea party, classic cars…so many options.
Use tags to highlight documents and events that should be addressed in the next Management Review. For example, let's say you perform a Management Review every 6 months. Create a tag for your next Management Review (MR-H12023) and apply it to any new document created prior to that management review. Then when you are preparing for your next management review, do a tag filter to quickly identify all the H1 2023 documents.
Questions and Answers from the Webinar
How can we utilize Qualio for measurable quality objectives?
The objectives can be measured by the data. For example All CAPAs will be closed within a due date. You can collect the data the Quality Events for CAPA if they all were closed within the due date and review the data.
Is the Management Review document created in Qualio using a template?
Yes. All documents in Qualio are based on a template. While you can create and use a generic, general use “Quality Record” template for random documents, we recommend creating a unique document template specifically for Management Reviews. This will provide repeatable structure to your Management Review documents now and in the future. We’ve provided an example template in this article.
Are the graphs and visuals displayed in the slide presentation available with Qualio or did you extract the data and use an external program to generate the visuals.
The data was first exported from Qualio, then we used pivot tables in Google Sheets along with their chart features to create the visuals. Customers can use any external program that can import the data from a CSV.
Can you add the graphs directly into the management review document? Or do you have to take screenshots and add to the document as pictures?
Because Qualio documents does not currently have “chart/graph” functionality you’ll need to save screenshots of the visuals and add to your document as images. Other things to consider:
Use the chart/graph functionality in your slide program (PowerPoint, Google Slides, etc.) and keep visuals in your slide deck that will be attached to the final Qualio document.
Document aggregated data in your Management Review document in a table - which is available functionality in Qualio Documents.
Can you input data from Qualio directly/automatically into a Management Review in Qualio?
Unfortunately no. Functionality like merge fields within a document or document template are not available. Data will need to be collected, analyzed, possibly sanitized and manually added to the Management Review document.
How do you suggest Action Items be tracked in Qualio?
Sumatha demonstrated in the webinar that an Event template can be created and an event generated for each Management Review. Then leveraging the Task Step type, tasks can be created and assigned to team members and monitored and tracked to completion by the larger Quality team.
Wouldn’t it be less complex to manage all management reviews within an Event template? The first step could be a content step with all the details outlined in your document template? What is the advantage to using both a document and event?
Option 1: using only a Quality Event template
Pros: You can have all the steps in the Quality Events, and assign the tasks.
Cons: suppose you have Customer audits, you may want to share on a high level the records of the Management review that was conducted and not the actual action items, to whom it was assigned, etc. . But if you use Quality Events everything will be in the same record
Download the Event Template for this scenario by clicking here.
Option 2: using only a Document template
Pros: for a smaller team where you do not want to send back and forth for approval for every step, using a only document template will be helpful.
Cons: if you want to assign the action items that need action, then you may have to use the Quality Events template.
Option 3: Combination of both Document template and Quality Events
Pros: 1. You can have the record of the Management Review in the document template. During the audits you can share the Management Review document template, action items are not readily visible to the auditor. If the auditor asks then you can take them to the actual action item. In this way, you can limit access to the action items.
Pros: 2. It is something similar to Internal audits. You use a document template, to perform an Internal audit, in the same template you can record the audit plan, an audit checklist can be added, and in the attachments section you can add the auditor's certificates, any objective evidence, etc, add the audit findings, and finally when you have to log the CAPA, then you use the Quality Events template. Similarly same for Management Review you can use both the document template and the Quality Events template.
Cons: it may be complex for small teams to use both. But it is up to the user to see how they can adapt these options.
How do completed Action Items drop off from the list? Automatically based on status or manually?
If you are referring to the action item list on the document: action items will need to be manually updated once the status changes to completed along with adding any additional notes/context.
If you are referring to the task within Qualio and viewing the Tasks page: This page can be filtered by status, owner, etc. to create a targeted list of what you wish to view.
You demonstrated creating a smartlink to an event within the document. Is this feature currently available? I only seem to be able to create a smartlink to documents.
It is a link/attachment and not a smartlink, you can copy the URL from the quality events and add the link in the related document template. See Document Editor article.
Can you create an API integration to connect it with a Google Sheet?
Thank you for the enhancement suggestion. It has been logged on our Product Board.
How do you ascertain that you have reviewed all pertinent regulations that impact your business? This is documented so it is important to have evidence of completion.
Generally the referenced documents are used for compliance and improvement of Company's Quality System can be listed in the Quality Manual and you can also list them in the Quality Plan. You can use the Regulatory document template where you can list all the Guidance documents, ISO standards that are applicable. You can review on timely basis these standards and can update the impacted QMS documents. You can share during the Management Review meeting as well.