Instruction: You are required to populate three documents as part of this assignment i.e. the Management Review Guideline document, the PESTEL analysis (see details below) and the Management Review Template document.
Information: Use the lecture notes provided so far in Management Review process, also the ICH Q10 guideline document (Management Responsibility Section 2. A Management Review example from Astra Zeneca is also provided for information purposes in the assignment folder.
Note: The key elements that an auditor would look for in a Management Review document are;
A Company Risk Register showing all the major risk areas that could affect the current and future performance of the Company based on the PESTEL analysis (Political, Economic, Social, Technical, Environmental, Legal)
The Management will then prioritise these risks and crystallise them into a series of key Company objectives for the coming e.g. Quarter, 6 months, year.
These objectives will then be worked into follow up action plans where the Quality Management System will be updated to align it with the Company Objectives.
Most Important: Use the knowledge you have gained in your working career so far to provide a Company profile (no actual names to be used) at the beginning of the Management Review template. The remainder of the document should then be used as a tool to describe the current attributes and on-going improvement needs of this Company.
Outcome of this assignment: Your submission should provide a Management Review Guideline document which details the information (based on all the source information above) that should be populated in the Management Review Template document. The PESTEL analysis should provide a list of potential risk areas that could impact on the Company’s performance and need to be actioned in the Management Review. The Management Review Template should have the detail and overall feel of a Management Review document that you have prepared as a Quality Engineer in conjunction with the Senior Managers of a Company and are satisfied to have this submitted into the Company’s Quality System Management Review records.