Step 6: Is quality controlled?
Every pharmacy must have a system in place to ensure there is control of quality processes and documentation.
This includes:
- Who can change and amend processes and documents
- How this change will be managed, including version control If there are changes to the quality system these should be recorded. If there is no control, a quality system is doomed.
Step 7: Is an internal audit programme in place? Is corrective action recorded? Are risks identified?
Central to continuous improvement is internal audit. Critical functions and processes should be audited at least twice a year. Internal audit will identify weaknesses and noncompliance with the quality system.
Issues that arise from internal audit then need to be addressed with corrective action. Does your pharmacy undertake audits? Do you have this skill?
Identifying risk is important. What areas represent a risk to the pharmacy of achieving its overall quality goals?
For example, employee training could be a risk and also a plan of action must be undertaken to mitigate this risk. Have you identified key risks within your practice?
Step 8: Are training records maintained?
Training and maintaining good records is a key component of a quality system. When training takes place, a record should demonstrate:
- Who was trained?
- Who delivered the training?
- What the training content was and what processes were covered during training
- How the training was delivered (for example, as a one-to-one)
- When the training took place
- How the employee was evaluated (for example, through multiple choice or by visual demonstration of a process).
Employees should sign and date their training record, and the record should be stored safely. Each job role in the pharmacy should be mapped to those processes that underpin that role.
Then each employee should be trained in those processes and full records maintained. Do you have a comprehensive training system?
Step 9: Are processes reviewed?
Many pharmacies fall down in this area. They produce a folder of SOPs which sits on a shelf. Processes should be reviewed to identify any changes that have happened and must reflect the actual activities within the pharmacy.
Engage employees in the review process, as this encourages ownership. Are your processes in a format that can be easily understood by employees? Flowcharts are often a good way to communicate processes.