Dave Rushton
Founder
of Paradigm Shift Consulting Limited.
Dave Rushton is Founder of Paradigm Shift Consulting Limited, a Good Distribution Practice Consultancy.
Audit Planning: Tips and Tricks
Tips for Audit Planning
Whether you are performing a ‘First Party’ internal audit, otherwise known as a self-inspection, a ‘Second Party’ external audit, usually relating to a supplier or customer, or a ‘Third Party’ audit, audits performed by a regulator, accreditor or an independent auditor, it is important to first understand the reason for the audit.
First Party Audits
A First Party Audit can be performed for a variety of reasons:
- To check for compliance against guidelines, standards and regulations.
- To evaluate the effectiveness of implemented corrective and preventative actions following a deviation, or customer complaint.
- To ensure actions performed as part of a change control have been effective, and any potential risks have been mitigated.
- To promote continual improvement of your Quality Management System (QMS).
- To meet the requirements of Chapter 8, Section 8.2 of the EU GDP Guidelines.
- To confirm the effectiveness of the current QMS and identify any deficiencies before a third-party auditor finds them.
Second Party Audit
A Second Party Audit is usually performed on suppliers and in some cases, customers, these audits are performed:
- To check for compliance against guidelines and regulations.
- As a risk-based approach to onboarding a new supplier so that they understand your requirements of them.
- To check the ongoing suitability of a supplier.
- To follow up on previous areas of concern with the supplier.
- As a result of a deviation against an agreed Quality Technical Agreement (QTA).
- Following a significant change to supplier operations, personnel or premises.
- Customer audits are performed to check their suitability as a customer and to check their current compliance status.
Third Party Audits
Third Party audits are usually conducted:
- For regulatory purposes.
- For certification or re-certification purposes, e.g. ISO accreditation.
- As an impartial confirmation of your current compliance status.
Now that we have understood the types of audits and the reasons why they are performed, we will look at Audit Planning.
Audit Planning
Audit Planning means before performing an audit, it is important that you establish the who, what and why’s of the audit. For example, when performing a First Party audit of your goods-in procedure, you may want to speak with the Warehouse Manager, look at the goods-in procedure and check that the activities performed by warehouse operatives match that of the procedure.
This audit may be to check the compliance status of this procedure against the relevant regulations, standards and guidelines as well as your own internal procedures, or may be as a result of a deviation relating to a received delivery.
When planning your audit, a planning document is a useful tool to guide you through the audit.
It is recommended that planning documents include the following:
- Date and time of audit.
- Location of the audit.
- Details of who will perform the audit, if more than one person will be performing the audit:
- Appoint a lead auditor.
- Define what areas will be audited by each auditor.
- Details of who you may want to speak to during the audit, this may be the Quality Manager, the Warehouse Manager or Operators who perform the day-to-day tasks.
- The scope of the audit.
- The criteria of the audit e.g. Operations – Goods-in
- The reason for performing the audit, is this a ‘for cause’ audit or a routine compliance check.
- The key areas to review.
- Your objectives.
- Documents you may want to review. Reviewing documents in advance of the audit can save you time on the day!
- A checklist of areas to view and questions to ask to guide you on the day.
It is important to remember that as your planning document is not fixed, you can deviate from your plan and then use it to pick back up on where you left off on the day. When performing an audit, you could see something concerning in a different area that you may consequently want to review it.
Don’t ignore any other sightings you may have because that area is not on your planning document. Deficiencies in any GDP area can impact your own compliance levels and can impact your third party audits leading to deficiencies against your own GDP operations!
Assistance and Support
Paradigm Shift Consulting offer a range of auditing services including performing Third Party supplier or 3rd Party Logistics (3PL) provider audits on your behalf, performing a full QMS gap assessment on your organisation, and providing Quality Assurance Specialists to assist your team when performing First Party audits.
We also have a cost effective ‘Introduction to Auditing’ online training course which can be taken at a time convenient to you and your organisation.
Please contact us today either via the contact form below or call us for a free 5-minute consultation on the phone number at the header of this page to see how Paradigm Shift can help you ensure compliance within your organisation.