Module 1: Writing for the Audience
- Writing for the audience.
- Getting the message across.
- The Outside-In approach.
- Word choices and editing.
- Do’s and Don’ts of Writing for the Auditor.
Module 2: Writing Problem Statements
- Stating the issue from the Outside-In.
- Identifying the What, Where, When, Who and How of the issue.
- Giving each of the above the prominence it deserves.
- Communicating the risk associated with the issue.
- Documenting containment actions.
- Viewing the problem through the eyes of the auditor.
Module 3: Defining the Root Cause
- Writing Root Causes based on RCA tools such as Fishbone and 5 Whys.
- Documenting the investigation.
- Presenting the information using a logical flow.
- Writing the rationale for the root cause.
- Documenting the rationale for the exclusion of potential root cause candidates found not to be part of the actual root cause.
Module 4: Identifying Verifiable Corrective Actions
- Identifying corrective actions that address the root cause not the symptoms.
- Identifying corrective actions that are implementable.
- Establishing how the effectiveness of the corrective action will be verified.
- Documenting corrective actions that are verifiable.
- The Investigation Summary.
Module 5: Applying the Learning to Other Documents
- How to apply the learning points form the course to other documents such as;
- Change Controls
- Memos
- Procedures and Work Instructions
- Issuing instructions and the use of the imperative.
The programme will be built around the client’s examples and requirements, and will feature practical exercises to help learners hone their skills during the course.
At the end of the course each participant is asked to prioritise a personal list of learning points and to commit to implement these when writing deviations or investigation reports.