How do you manage risks with quality documentation?

1 Define your documentation requirements

The first step is to identify and define your documentation requirements, based on your quality objectives, standards, regulations, and stakeholder expectations. You need to specify what types of documents you need, who is responsible for creating, reviewing, approving, and updating them, how they will be formatted, stored, and accessed, and how often they will be revised and audited. You also need to establish clear criteria for quality, accuracy, and completeness of your documents.

2 Implement a document control system

The second step is to implement a document control system, which is a set of procedures and tools that ensure that your documents are properly managed throughout their lifecycle. This system should enable you to assign unique identifiers, versions, and dates to your documents, track their status and history, control their distribution and access, protect them from unauthorized modification, deletion, or disclosure, and retain and dispose of them according to legal and operational requirements.

3 Train and communicate with your staff

The third step is to train and communicate with your staff, who are the main users and creators of your quality documentation. You need to ensure that they understand the purpose, importance, and benefits of quality documentation, as well as their roles and responsibilities in following the document control system. You also need to provide them with the necessary skills, resources, and feedback to produce and use quality documentation effectively and efficiently.

4 Monitor and measure your documentation performance

The fourth step is to monitor and measure your documentation performance, which is the extent to which your documents meet your quality requirements and support your quality goals. You need to define and collect relevant indicators, such as the number, type, and frequency of documents, the level of compliance and satisfaction with document standards and procedures, the occurrence and impact of document errors or issues, and the improvement opportunities and actions taken. You also need to analyze and report your findings and recommendations regularly.

5 Review and improve your documentation processes

The fifth step is to review and improve your documentation processes, which are the activities and methods that you use to create, manage, and use your documents. You need to evaluate and compare your documentation processes against your quality requirements, best practices, and stakeholder feedback, and identify and implement any changes or enhancements that can improve your documentation quality, efficiency, and effectiveness. You also need to monitor and evaluate the results and outcomes of your improvement actions.

6 Learn from your documentation experiences

The sixth step is to learn from your documentation experiences, which are the lessons and insights that you gain from your documentation performance, processes, and improvement actions. You need to capture and share your documentation experiences with your staff and stakeholders, and use them to inform your future documentation decisions, plans, and actions. You also need to celebrate and reward your documentation achievements and successes, and foster a culture of continuous learning and improvement.

7 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?