Regulations and standards in some industries require an organization to maintain readiness for control, audit, or inspection. Examples include GMP (Good Manufacturing Practices) in the pharmaceutical industry, MDR (Medical Device Regulation) for medical devices, and more recently the AI Act for high-risk AI systems. Maintaining inspections readiness requires coordinated cooperation between the relevant units, and this is where the use of assurance case can be helpful. The assurance case structure ensures that audit objectives are explicitly linked to the evidence. It also supports control over the documentation timeliness and change management. When implemented for a process or system, dynamic assurance cases are an effective means of maintaining inspection readiness. An assurance serve as a knowledge base on readiness, and at the same time it has mechanisms to help control consistency, completeness and maintain up-to-date evidence.
Effectiveness and vulnerability detection
Structured arguments force the connection of compliance goals with all evidence items into a logical chain of dependencies. This makes audits easier. This is useful for maintaining readiness for inspection. Assurance case tools show the readiness status for each area in real time. When an assurance case is integrated with a document management system, it is possible to efficiently verify readiness for inspection. This allows for quick detection of gaps and vulnerabilities, and after all, the point is to detect and fix them yourself so that they are not detected during external audits.
Most of the time during inspections is spent searching, selecting and preparing data, rather than analyzing it. Sometimes the analysis is only 20% of the control time. The use of assurance case changes this, because the data is organized from the beginning and this is maintained at all times. More time can be spent on analysis. Audits are more effective. Even if the initial structure of the argument is not optimal, subsequent inspections also provide feedback to help improve it. Good assurance cases ensure high inspection efficiency.
Structural arguments facilitate inspections and verifications, which can sometimes be interpreted as helping the inspectors rather than the inspected units. But here we control our own readiness for inspections and this feature of the assurance case becomes an advantage for us.
Assurance cases are a universal solution effective at the level of the entire organization, it can include various business units, systems and technologies. In this way, the assurance case also becomes a communication platform.
Communication and clear responsibilities
A single inspection readiness management platform creates a means of communication not only between units of the organization, but also in communication with inspectors. Because assurance cases facilitate inspections, inspectors are happy to work with them. Each section of the argument has a clearly defined goal and context, making communication more specific and goal-oriented. There is less ambiguity and misunderstanding of the other side, which helps to create a more positive and productive environment.. The problem of information silos is practically reduced, because the decomposition of argumentation is automatically linked to responsibilities for its parts.
Individual parts of the assurance case have their owners, so they automatically participate in communication on a given topic. We avoid a lot of ambiguity about liability. For each piece of evidence, the argument also specifies its source. Such information makes it easier to assign responsibilities and shows the inspectors that the organization has real control over the areas covered by the inspection.
Change management
When there is a change in a process, product, or regulation, an assurance case allows to quickly evaluate its scope. The argument structure helps to identify the argument branches that need to be updated. If there are relationships, they are explicitly defined in the argumentation and are taken into account in the analysis of the scope of changes.
Some changes are due to the passage of time itself. Evidence of compliance is often not valid indefinitely. Their expiration is reported and causes the need to run specific actions, such as performing a re-review and renewal.
All changes are explicitly specified and reported. Reports show the current state of readiness for inspections, indicating areas requiring action or expected to require action in the near future. The assurance case data is subject to configuration management and versioning. This enables analysis of any previous version.
Customization and scalability
Changes can also result from business decisions and events. By their nature, assurance cases provide the flexibility to adapt the structure of argumentation to the specifics of processes or systems. This gives us flexibility while remaining under the control of change management processes. At all times, the consistent argument structure and the associated evidence are maintained.
Divide and rule. This principle also applies to the assurance case. We can divide the case into modules and distribute responsibilities accordingly. This is integrated with permission management, authorising the right people to perform tasks such as providing and updating evidence, or conducting reviews. The entire assurance case solution can be scaled for large organisations and systems.
Summary
Applying an assurance case to manage inspection readiness requires a little more work at the initial stage, but later, during maintenance, it significantly speeds up the implementation of inspections and makes them more efficient, also from the perspective of an organization demonstrating compliance and readiness for inspection.
Andrzej Wardziński
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