At this time of year many of us are surveying the wreckage of our laboratory internal audit programs, wondering if we can fit in a couple more before the end of the year and reign in the backlog. Rest assured that you are not alone!
This is a good time to review your approach to the audit program and see how you can shake it up a bit. Think about what determines the success of your audit program. Is it whether every single audit that was on the schedule was completed on time? Or is it whether your senior management are happy with the outcomes and control of risks?
Don’t confuse purpose with objectives
The purpose of an audit program is to do audits. If you only focus on the purpose, you will just keep on doing audits, producing reports and piling up a lot of minor non-conformances. This is when we can get demotivated and disenchanted.
Take a look at your laboratory’s objectives and think about how the audit program could support them. If your organisation wants to become more efficient, then your audit program should be aiming to identify process improvements that can save time or resources in producing test results. This will inform what approach you take to audits – you may move away from looking for compliance to adopt a process approach.
If your organisation is new to accreditation and just wants to meet NATA’s (or ISO) requirements, then auditing for compliance with the criteria documents can be a priority. This is also a great way for staff to learn about the requirements. But avoid getting stuck in this type of auditing for too long, as it rarely leads to any real improvements.
When the customer is the primary focus, your audits should concentrate on making sure that customer requirements are met. This might mean looking at timeliness of results, accuracy of reports, and responses to customer feedback and questions. If your lab is involved in sampling, you’ll want to audit how often repeat samples have to be collected as well as the actual sample collection method.
Common objectives for an internal audit program are:
- to fulfil external requirements (i.e. NATA & ISO)
- to identify risks
- to verify compliance with contractual and legal arrangements
- to identify improvement opportunities (waste) in laboratory processes
Finally, make sure you get senior management involved in setting the objectives – don’t keep them to yourself!
Get to know what internal audit really is
Internal audits can be a whole range of things, not just the ‘tell me, show me’ style of audit that many of us have used for years, believing it was the ‘right’ way to do audits.
If you follow the trail of references from ISO 15189 and ISO/IEC 17025 looking for a definition of audit process, you won’t find one that specifies a particular approach. The laboratory accreditation standards lead us back to ISO19011 Guidelines for auditing management systems, which defines audit as a:
‘systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled’.
So any activity that provides you with the information you need to ‘determine the extent to which audit criteria are fulfilled’ can be an audit. This means you can include a whole range of activities as part of your audit program, so long as evidence is collected and used to assess compliance with audit criteria. It also means that you can use internal auditors with a range of different skills to collect the information.
When you combine this with a clear understanding of the objectives your organisation has for the audit program, you can develop a much more focused program, using audit techniques suitable for the type of information you want to collect.
Adjust the audit schedule
To align with organisational objectives in the context of changing regulations, staffing and new tests, the audit schedule must be flexible. And sometimes it is just not feasible to conduct the audit at the time it was originally scheduled. Unfortunately NATA can have trouble understanding this and at times views every overdue audit as a non-conformance. Different laboratories have adopted a variety of methods to avoid being told ‘you must stick to your audit schedule’ repeatedly and ending up with a ‘major condition’.
It would be madness to stick to an audit schedule conceived in the peace and calm of the beginning of the year when new risks and opportunities arise during the year. One simple way to ensure that you don’t end up with a NATA condition for not sticking to the audit schedule is to keep a record of the change and who approved it. This might be in meeting minutes, for example.
So when there are frequent staff changes in a section, or new regulations & requirements make sure you do adjust the audit schedule. Management will be grateful that you addressed those risks, rather than just keeping on with ‘routine’ audits.
You need to balance many different factors when designing an audit program. If you keep the objectives in mind, and remain open to different types of audits and flexible with your scheduling, you will have a program that doesn’t just meet the requirement to have an audit program, but one that actively assesses risk, updates the organisation to new requirements and responds to changing external influences.
If internal audits are getting the better of you, O’Dwyer Accreditation can help with contract auditing or a review of your audit program. Phone Cathy now to find out more: 0414 859 507.
Find out more about internal auditing courses.