Simplify the reporting and organization of your audits
In the quality management system context, the internal auditing process aims to evaluate the procedures in place in the company. Every internal process should be audited at least once a year, depending on the annual internal auditing program.
The objective is to ensure that procedures are:
- Effectively implemented
- Known and controlled by everyone
- Associated with controlled documentation
It thus contributes to the continuous improvement of the quality management system.
These audits are intended to bring to light potential strengths and points for improvement in order to enhance the QMS processes over time.
We aim to detect four types of deviation:
- Understanding: The participant has not read or understood the process; this usually involves a problem regarding internal communication or an explanation in the process documentation.
- Application: What is described is not what is done in reality. In this case, it is necessary to ask why and to consider what action seems best in order to change the actual process or working methods.
- Documentation: Poor process description/poor formalization of quality documents. Revision of the documents or the process description is usually required in this case.
- Effectiveness: The process is not effective/efficient. It is then necessary to review the process to make it more effective.
Each internal audit involves interviewing one or more participants and the process leader. These interviews generally take 15 to 20 minutes.
Typical internal audit questions
Here are some examples of typical questions that may be asked (to be adapted to the process and the issues identified during the preliminary analysis):
- Have you read the process documentation?
- What did you understand? Do you apply it?
- How often? What is your role in this process?
- When do you intervene? Do you think it is effective/efficient?
- Is there too much/too little control? Have there ever been problems/incidents? How were they resolved?
- For control steps: Why are checks performed?
- If sending documentation to a customer without checks: Why?
- Upstream process: Is the input data clear/complete/provided on time at each startup?
- Downstream process: Is the expected data properly produced/complete/provided on time?
- Connected process: Combination of upstream and downstream.
Then, for the leader interview (usually longer), a few additional topics can be discussed: They should be asked about conflicting narratives (without reporting on what was said).
- From an efficiency/effectiveness standpoint: Were there any non-conformities (Ncs)/incidents? How many in progress/completed in the period? Has there been any customer/supplier/employee feedback?
- Regarding metrics: Are they followed up? Analyzed? (how? by whom?) Relevant? Easy to calculate? How are the participants trained?
- What are the possible improvements to this process?
Auditors must be selected from the list of certified auditors. This auditor should not be the process leader.
What does the process consist of?
First, the quality manager will define the audit plan and choose the team to audit. Participants will be automatically alerted to ensure that everyone prepares for the audit. During the audit, notes are recorded in Iterop along with the corrective actions to be implemented. A “corrective action implementation” subprocess that includes the identified deviations is called.
Once the audit steps are complete, the report will be sent to the entire team and archived in the current document management system (DMS).
The following are the key indicators associated with the process:
- Unprocessed discrepancy rate
- Ineffective corrective action rate
- Audit no./process/year
- Processing delay
Process leader: quality manager
Process Initiator: quality manager
Process participants: all process leaders
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