As you know, we’ve been thinking and writing about what the world could look like, if we use the Coronavirus situation to our advantage.
Using the feedback we received from our article ‘What will life after Coronavirus look like’ and having then thought about it some more, we’ve come up with an idea – which we’d like to share with you.
How you can help
Our idea is quite revolutionary and with anything new, there will always be things that will stop it from reaching its true potential – so that’s where we need your help. We need you to rip this idea apart and tell us all the reasons why you think it won’t work. That way we can tackle each problem, one by one and fix them. Please be as critical as you can, we really do want you to be – as it will only help us, to make it better. So, without any further ado, here it is…
Imagine there is a cloud-based system, which you can log onto – to do your internal audits.
Depending on which Standard you work to, or which customers you make product for – there are pre-loaded system audit proformas on the system for you to use. The system also holds your GMP inspections.
Each systems audit topic has what we call ‘cross cutting themes’. This means that when you do a foreign body detection audit, you also audit the training of that topic and the document control of that topic. So, training and document control are ‘cross cutting themes’ as they apply to everything when auditing. This means you’re not auditing these topics once a year, but actually every time you do an audit – because they are important and we need to make sure they are robust.
You can complete your internal audit risk assessment on the software, which works out for you, at what frequency each of your systems audits should be done and also, the frequency at which your GMP inspections should be done.
You then assign an internal auditor to each system audit topic and each departmental GMP inspection.
When the audit is due the system emails the internal auditor.
The auditor wears a pair of glasses to do the audit, which records the audit. This is also the case for GMP inspections. The video eliminates the need for uploading paperwork as evidence or taking photos.
The auditor fills out the systems audit proforma or the GMP inspection either on a PC or on a tablet in the factory.
Any non-conformances are agreed with those that are responsible for them and they are instantly emailed to those who need to complete them.
When a non-conformance is received, the person responsible for it can complete it on the PC or on a tablet and upload evidence. On completion, this is sent back to a designated person to verify before signing it off.
Here’s where it gets really good.
The site can share their internal audit system; the systems audits and the GMP inspections with their customers.
The customer can log into the system and see their internal audits, GMP inspections, watch the videos, read the audit reports, and assess the close out of the non-conformances.
This means, that if they want to, they can re-audit any of the audits themselves, to establish if they would have come to the same conclusions.
If they feel that there are gaps in the audits, they can contact the site to ask them to fill in the gaps. This ‘gap filling’ audit would then be conducted following the same process and everything uploaded to the system for the customer to see.
If the customer, wants to share this information with their customer (up the supply-chain) they can do so, with site’s permission and permissions on what they can see can be set.
This way, in theory the information can be shared all the way up the supply-chain to the retailer.
Providing visibility and this much detail to the retailer will allow them to carry out a much more comprehensive risk assessment of their suppliers and supply-chain, which in turn, will allow them to more confidently focus more on the sites who need it. Therefore, reducing audit frequency at sites who are on the system.
All sites who are using this system, are listed publicly, so that buyers can see which suppliers are working transparently. The list will not show anything about what ‘score’ the site has, because getting non-conformances is not a bad thing, if they are resolved and the site is continuously improving.
We’ve started to work through some of the benefits and issues with this idea, which we’ve outlined below.
The site customer doesn’t need to visit to site to do an audit, in order to verify and approve them as a supplier. As they can audit their supplier virtually – reducing costs to the customer.
Because the customer doesn’t come to site to do an audit but uses the internal audits that would be happening anyway, this frees up time in the technical team to focus on improvement, rather than hosting audits.
Because third party audits are not repeating the same things, but rather looking at what’s been done and either drilling down where focus is needed, or filling gaps in the audits – this drives improvement for the site.
There is a commercial benefit to sites who are on the public list, from a customer point of view.
Typically, audit reports contain the names of employees. Therefore, there are GDPR implications. This could be resolved by adjusting the way we work, so that employee numbers are recorded rather than names. The aim is to allow traceability of paperwork, so an employee number would do this, if it is used instead of a name.
Trust is a big issue. Because the internal audits are scheduled, rather than unannounced, it means that they could be staged. However, by including the GMP inspections, which are done much more regularly, staging these would make it hard if not impossible.
What to do next
We’ve create a simple 3 question idea feedback form. We would be ever so greatful if you could fill it in for us please. It shouldn’t take more than a couple of minutes.
We've tagged this article as: Internal audits
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