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For internal and external auditors: 5 steps to implement remote ISO/GMP audits

8 MINUTE READ

The current COVID-19 crisis has forced manufacturing companies to rethink how to keep workers safe. While there is a limited scope for remote work in most manufacturing activities, audits can actually be done remotely reducing cost and risk.

At Unifize, we’ve been able to help our customers conduct remote audits using our software platform. As an example, The Will-Burt Company, an Ohio-based manufacturer, has been able to conduct internal audits on a factory location in Tulsa that’s nearly 1000 miles away from their head office.

You can read the complete case study by clicking here.

“We can probably do 90-95% of our audit without stepping into the Tulsa location”

Director of Quality

Why should I be reading this?

You should take 8 minutes to read this if:

  • You manage quality or internal audits, and you’re looking to streamline how internal audits are conducted at your company
  • You’re worried about not completing your internal audits because scheduling/conducting on-site meetings is difficult
  • You’re an ISO/GMP auditor looking to reduce risk/cost associated with conducting ISO/GMP audits
  • You’re looking to increase traceability on your internal audit process
  • You’re under home quarantine, and your version of fun is reading articles like this

Why haven’t we all been doing remote audits up until now?

Auditors have always preferred conducting audits on site. There’s many reasons for this – let’s look at some examples from a survey we conducted: 

  1. Auditors feel like they won’t get an understanding of the process without being present
  2. Auditors are afraid they’ll miss something crucial if they aren’t on site
  3. Auditors and participants feel that the audit process is too difficult/confusing to conduct remotely
  4. Auditors feel that it’s hard to be organized on the volume of data required to be exchanged

There’s nothing wrong with these concerns. However, each of them can be mitigated when conducting remote audits if you use the right tools and prepare in advance. This is the key concept.

During COVID-19, the obvious benefit of remote audits is that you can reduce the risk of catching the disease by limiting your in-person meetings. No one has yet caught the virus from an email 🙂

Certainly, a completed audit is better than no audit.

Before we learn about how to conduct audits remotely, let’s understand what ISO has to say.

ISO guidance on practicing remote audits

In April 2020, the ISO Audit Practices Group released guidance on completing remote audits.  This guidance acknowledges that new Information and Communication Technologies (ICT) have made remote auditing more feasible and that the ‘value of this audit method resides in its potential to provide flexibility to achieve the audit objectives’.

ISO has created detailed guidelines on conducting remote audits (you can find out more here). In this article, we will look at the more practical aspects of conducting remote audits.

“These techniques transform the way we work. These information and communication technologies open the opportunity to audit sites and people remotely, shortening distances, travel time and costs, reducing the environmental impact associated with audit travel, adapting audits to different organizational models.”

ISO 9001 Auditing Practices Group

The benefits of remote audits

Remote audits reduce the need for meetings

Meetings are, by definition, synchronous.  Specifically, they require multiple people to stop whatever else they were doing and focus on the audit.

By using information and communication technology properly, a large amount of the audit work can be made asynchronous.  This can actually increase the effectiveness of your audits by allowing people the time and space to complete certain tasks in their own time.

Remote audits can actually be better audits

Audits are expensive and time consuming.  They also require people with different skills to come together to be effective.  As the ISO Audit Practices Group itself says that the effective use of Information & Communication Technologies during a remote audit:

‘…allows for the inclusion of expertise in an audit that otherwise might not be possible due to financial or logistical constraints. For example, the participation of a technical expert may only be needed to analyse a specific project for only two hours. With Information & Communication Technology available the technical expert may be able to analyse the process remotely, thereby reducing time and costs associated with travel’.

Remote audits can give you better visibility & traceability

By effectively using information & communication technologies, remote audits can actually increase traceability and give quality leadership better visibility into the progress of simultaneous audits.  Communication before, during and after the audit that was otherwise unrecorded or scattered across different email inboxes can now be part of the audit trail.

Step 1: Select the right tools for conducting your audits

Selecting the right tools will go a long way in making your audit successful. You will need to cover these basics.

Live meetings – about 5%-10% of the work

  1. Phone conference – ideally make sure you can record calls if required.
  2. Video conference – Phone calls can be substituted with a video conferencing tool of your choice. Minimize the meetings over video as they aren’t efficient and can cause fatigue. Make sure you record your calls – and advise participants / auditees that they have access to the recordings.

What are your options?  Zoom, MS Teams, Google Meet, Blue Jeans, Cisco Webex are some of the popular tools

 

Asynchronous collaboration – about 95% of the work:

  1. You will need all your tools to be cloud based (or at the very least, your participants/auditees should be able to access them in real time).
  2. You will need to select a tool for asynchronous communication. Conducting all your work over the phone/video meetings will be impossible.
  3. You will need a place to organize all your files into categories.
  4. You will need to manage a checklist of items. Ideally, this checklist will update in real-time so both you and the participants can track progress.
  5. You will need to track/assign ownership for each step of the process.
  6. You will need to create reports and print out pdf forms.

     

Option 1 – a combination of multiple tools:

Your first option is to use a variety of different tools, ideally all of which will be integrated with one another:

  1. Asynchronous communication – Slack, MS Teams, Flock. Do not use email unless you want to create a collaboration nightmare
  2. Project management tool to create checklists, track ownership and status of tasks – Asana, Trello, Basecamp, Airtable, Monday.com
  3. Data collection on the cloud – Excel 365 or Google Sheets
  4. Reports – use Excel/Sheets formats
  5. Files – use Google Drive / Dropbox / Office 365 to manage a set of folders and sub folders. The project management tools above can also perform some basic file management

     

Option 2 – Use Unifize

Unifize is a cloud-based collaboration platform that has been built to address the needs of quality teams conducting remote audits.  It enables both auditors and auditees to plan, execute and review audits both asynchronously and in real-time, where required.

Unifize is the only tool that covers all the asynchronous collaboration requirements in one place, including those specified by the ISO remote audit guidelines.

Step 2: Get on the same page about the tools and security/privacy requirements with auditees

If you’re conducting an internal audit, your team should be familiar with the tools and protocols you use. If not, it’s better to educate them on what the tools are, and ensure they have access.

If you’re conducting a remote ISO audit, you will need to agree on the above set of tools before you get started. Try to use the minimum amount of tools by using Unifize. However, if your auditee/participants are already used to certain tools, that might be a good starting point.

Ensure that you have an agreement on data security and privacy before you start.

Step 3: Prepare your auditees/participants on what documents they will need to produce in advance

By sharing a checklist of documents and tasks with your auditees/participants in advance, you will reduce the need for a lot of meetings. You can create this checklist using the tools that are listed above.

Ensure that there are instructions (or a guide) on what can be expected. This could just be a single page of instructions.

Since you will be using a real-time asynchronous collaboration tool, you will be able to give feedback as your auditee uploads information. Quick feedback will ensure that this process is painless for both of you.

Step 4: Set a date and time for your audit - but ensure that your checklist is complete beforehand

By sharing a checklist of documents and tasks with your auditees/participants in advance, you can reduce the questions for the meeting. 

Ideally, you should have already responded to documents uploaded with feedback and follow-up questions. Having a traceable list of questions and answers on your collaboration tool will make the audit process transparent and easier to build documentation.

In your meeting (preferably over video conference), your auditee/participants might have to share additional documents with you. It is best that a copy of those documents also enter the asynchronous conversation so you can keep track.

Having too many surprises during the video conference is going to be disruptive to your auditee. As such, you may need to modify your audit techniques to keep these to a minimum.

Step 5: Ensure that gaps and deviations are created as tasks with owners and due dates

You’ve always documented deviations and gaps before. But since you aren’t present to explain clearly, you should create separate tasks for each deviation or task. That way you can collaborate asynchronously to ensure these are completed. 

Ensure that the relevant auditees/participants are assigned as owners on these tasks, and restrict communication to your asynchronous collaboration tool. Random emails and phone calls out of context will only add to confusion.

What if you can’t avoid an on-site audit? Plan your visit and make sure everything is ready

Every once in a while, you might have to conduct an onsite visit. To reduce the risk of contamination and wasted time, have a checklist of documents shared in advance. 

Ensure that you conduct a risk assessment to reduce the chance of contamination. You need to make sure all attendees are in place and wearing suitable PPE.

Make it short. While instincts might shout out for a more thorough investigation, the current times call for compromise. If there is any part of your audit that doesn’t require a visit, do it asynchronously.

If you need more help - reach out

Our process experts have implemented processes in hundreds of organizations. We can help you think through your audit and suggest ways to adapt to remote.

Please get in touch with us if you need: [email protected]

Alternatively, click here to book a demo directly with a Unifize process specialist to learn more on how the platform can be used to implement remote audits in your organization.

Ben Merton is CEO of Unifize, a software platform that makes every process collaborative for manufacturing companies. He is also a contributor for various publications on business, technology and entrepreneurship, including the Wall Street Journal, the Financial Times and Business Standard.  You can get in touch with him directly at [email protected]

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