Clinical audit consists of 6 key steps within the audit cycle:

  • Choosing the topic
  • Defining standards and criteria
  • Defining methodology
  • Analysing results
  • Implementing change
  • Re-audit
Choosing the topic

Clinical audit is a cyclical process that starts with choosing a topic to audit. Several factors could influence the choice of topic including:

  • Areas of patient care that are considered a priority for improvement locally e.g. highlighted on Pharmacy Needs Assessment or nationally e.g. NHS England or government priority
  • Pharmacy practice that is associated with a high level of risk
  • Services that generate a lot of patient complaints
  • Services that are new to the pharmacy
  • Practice associated with higher number of clinical errors or incidents
  • Ease of data collection or accessibility within the specified timeframe
  • Resources and support available to facilitate change identified as necessary
  • Available support:Will manager or colleagues agree with the choice
  • Other stakeholders involved in the audit e.g. patients, other healthcare professionals including local GP practices
  • When deciding on the audit topic it is important to focus on specific problem areas where there is room for improvement, every audit should focus on patient care and not simply be influenced by personal interest or experience.

Involving the pharmacy team in the choice of audit topic will increase staff participation in the audit and facilitate delivery of change to existing working practice.

Define standards and criteria

Criteria and standards are audit terminology that can be simply defined as:

  • A criteria is a statement that describes what is to be measured during the audit, criteria should always be SMART- Specific, Measurable, Achievable, Relative, Timely e.g.  All patients who are prescribed an inhalation device for the management of their asthma should be able to use their device
  • A standard is the definition of the success level that is expected e.g. 90 % of asthma patients are able to demonstrate how to use their inhaler device correctly

Once the topic is determined it is important to identify existing standards or guidelines that can be used as comparators. Suitable standards or guidelines could include:

  • Local policies or protocols including service specifications for currently commissioned services
  • National policies
  • Professional standards e.g. GPhC
  • Clinical guidelines e.g. NICE, SIGN, BTS

It is beneficial to investigate whether a similar audit has been conducted previously as existing data collection tools can be used.

Audit methodology

Once the topic is decided and standards or guidelines identified the next step is to determine what data to collect and how to collect it- this is where pre-prepared audit templates can be useful. These templates can either be used as they are or adapted to meet the specific criteria of the audit. It is important to ensure that the data collection tools when used effectively will collect all of the necessary data, and are easy and quick to complete.

Details of available audit templates can be downloaded from NumarkNet.

Trialling a data collection tool (e.g. with colleagues or the pharmacy team) will ensure that it is fit for purpose and avoids collecting the wrong data or recording it in a way that is difficult to analyse. Typically a trial of between 5-10 questionnaires will demonstrate the suitability of the data collection tool.

At this stage it is valuable to consider:

  • Was the data easy to collect?
  • Did the questions flow in a sensible order?
  • Could the questions be completed in a reasonable amount of time?
  • Could patients answer the questions on their own?
  • Are the questions acceptable to the patient i.e. easy to understand, non-offensive or intrusive?

Considering these factors will allow the audit tools to be refined if necessary before undertaking the audit.

Part of the methodology involves determining the sample size i.e. how much data do you need to collect for the audit to be effective, and how to identify the target population e.g. clinical condition, or user of a specific service. It also involves agreeing a timeline for completion of the audit. In an ideal world the audit will be completed using the simplest method for the shortest period of time.

Analysing the results

A spreadsheet can be used to collate, store and analyse the data collected. Comparison of the data collected with the standards or guidelines identified at the start of the audit will allow effective analysis and identification of under and over performance in specific areas, this in turn is used to identify any procedure or process that requires change to benefit patient care.

The analysis does not need to be complicated, it can be as simple as a tally chart or totalling the number of “yes” or “no” responses and calculating this as a percentage of responses.

During the analysis process it is beneficial to consider whether all of the information collected was complete and accurate, especially during busy times and if anything unusual happened that could have affected the results such as unplanned staff absence or locum cover.

Making changes

Once the analysis is complete it is important to discuss the results with key stakeholders including the pharmacy team, local GP practices or PCO- this will help to ensure that any proposed changes are understood, supported and implemented.

Changes made as a result of the data collected should be both necessary and achievable. Good communication skills and involvement of the pharmacy team will increase the likelihood of effective implementation of change. Any change also needs longevity i.e. it must become integrated into daily practice rather than stopping once the audit is completed.

Typical changes following clinical audit involve staff training, introduction of new guidelines and/or protocols, or the development of new ways of working.


The final stage of any audit is the re-auditing stage. This is not another audit it is an essential part of the overall process as it completes the cycle by demonstrating that any changes made have been effective and patient care improved.

Ideally re-audit should be completed 3-12 months after implementation of changes. In most cases the same data collection tools can be used to ensure that the results are directly comparable.

The outcomes of the re-audit should be shared with the key stakeholders identified at the start of the audit process.