Effective quality management is based on transparency and tracability. Determinding standards and policies and operating a system to establish and monitor and them. Medical technology and pharamaceutical industries must comply tot he highest standards as lifes do dependend on their application.
Deviations and deficiencies must be systematically tracked and resolved in a documented way – establishing an appropriate CAPA process.
From manufacturing medicinal equipment throughout pharmaceuticals production, integrated systems all along the supply chain are essential.
Consolidated, documented data and quick response times are a pre-condition to manage the operational, strategic and regulatory risk.
The toolset should contain:
- FMEA – Failure Mode- and Effects Analysis: Definition of thresholds, evaluation and criticality of deviations on quality – as expected by regulatory authorities and customers, consumers
- Deviation Analysis: structured and systematic approach ot a problem scanning all possible influence factors drilling down to the root-cause – with a traceable and dynamic project management – typically the general project plan is displayed as a fishbone or Ishikawa- Diagram graphically
- CAPA – Approval: Control and approval workflow for implementation of correction measures.(Corrective Action – Preventative Action
- Correction Project: project management for planning and managing the implementation of correction project incl. monitoring timely progress, budget and effort.
- CAPA-Dashboard: Overview on current quality situation, incl. Deviations, implementation projects, their priority and progress, product approval processes.
Develop your individual approach for your organisation, technology, market and regulatory context.
Embedded into the overall risk management, a centralised complaints collection, audits, employee observations and improvement proposals, goods entry checks, laboratory- /test reports, contracts or a social radar provide quality information form broad variety of sources. The co_suite includes all necessary modules and allow to detect patterns and analyse deviations from all the different sources on one platform.
Time and effort consuming data consolidations are no longer necessary. Quick insights, analysis and decision making allow reacting instantly helping to avoid life-threating crisis or harms to the reputation.
Eliminating (causes of) deviations
Once a risk materialises – detected from any of the various channels, it must be prioritised and evaluated. A FMEA beforehand minimizes time and effort of the analysis.
The cure can include a variety of correction methods from which the most appropriate (economic) solution must be implemented. This combination approved must spell out the measures clearly, plan the resulting tasks precisely and monitor their execution continuously.
Of course, and audit trail is necessary to document the appropriate procedure and risk awareness not only internally but to prove it to authorities and other stakeholders.
Compliance related Information
The information transfer among all organisational parts needs a documented and effective communication system. All modules and data that are relevant to compliance require a unified notification system tailored to the organisational structures, competencies and responsibilities. It must be designed to break the odour detection threshold of the recipient according to the level of risk.
Without IT a reliable and traceable communication for each individual position at any organisational level and geographical location an effective risk management becomes illusionary.
Therefore, co_suite is an integrated modular system that allows
- Displaying the influence and interdependencies of multiple, externals norms with the internal standards and instructions,
- Risk based implementation of and compliance with regulations,
- Structuring requirements to user, position, department and location related components,
- An audit trail – for communication, content and workflow,
- Product related reporting features,
- Encryption of security or confident information.
- Documents relates external norms with internal standards, policies and regulations risk based and process driven.
- Complaints collects criticism from any channel (social media, E-Mail, phone, …) Registered deviations or suggestions are assigned to solutions complying tot he own quality standards.
- Ideas is a Platform to collect observations of and proposals to cure shortcomings internally.
- Training ensures the coverage of the organisation with the necessary competencies.
- Contract monitors the harmony of rules and standards with legal and commercial conditions.
- Audits plans and records the investigation from independent internal or external staff detecting deficiencies in processes or operation.
- The module Issues plans and manages all initiatives beyond a routine workflow compliance related or not) and ensures a timely implementation.
- CAPA controls the discovery, analysis and tracking of deviations from the organisation’s quality standards documenting the elimination of the root cause.
- The integrated Dashboard displays workload, due dates and KPIs related to processes, products organizational units or level of risk.