DEVIATION MANAGEMENT & CAPA
Identify quality deviations and
develop measures to avoid them!
DEVIATION MANAGEMENT AND CAPA WITH SAP QM
No company process runs perfectly and so quality deviations are part of daily business. These include, for example, production and logistics problems, but also incoming customer complaints or deviations in the area of suppliers. Therefore, every company needs processes and tools (including dashboards and analytic apps) to detect quality deviations at an early stage, to track them, to correct them successfully and, last but not least, to avoid them in the future.
Deviations must be recorded and documented in a detailed error description. This can be done in S/4HANA using mobile apps with modern usability. After confirming the quality-relevant deviation, a detailed root cause analysis must be performed.
These causes form the starting point for identifying the measures required to perform corrections on the one hand and to implement preventive actions on the other.
Following implementation, the efficacy of these measures must then be assessed.
The life sciences industry in particular requires effective and reliable CAPA and deviation management. CAPA also forms part of the FDA and EU GxP guidelines, and is therefore relevant for manufacturers of pharmaceuticals and medical devices.
DHC digitises the CAPA processes in the SAP Quality Issue Management (QIM) module or with the help of the quality notifications (Q notifications) in SAP QM. The advantage of both solutions is the full integration into SAP ECC 6.0 & S/4HANA and thus the avoidance of redundant data and error-prone interfaces.
DHC CONSULTING SERVICES FOR DEVIATION MANAGEMENT / CAPA WITH SAP
In the business case, we set out the arguments for or against the deployment of the QM module in SAP and about the scope in which the module could be cost-effectively deployed. We also provide answers to the question of costs as well as the benefits achievable by a SAP rollout. We therefore assess the compatibility of SAP QM functionality with your company’s quality management strategy and the appropriate business scope for deployment of the module.
We work with your QM experts to specify the field of application and application scenarios for the 8D system, while also defining a high-level strategy. The objective here is to identify an implementation recommendation in SAP, including a rough implementation plan. You can then use this deliverable to specify your roadmap and the next steps to take. This then serves as a starting point for all of the next steps in the project, from decision-making and implementation through to the final cutover to production.
Proof of Concept (PoC)
We use a feasibility study to compare your requirements with the functional and technical options offered by SAP QIM or SAP ERP with QNs, and assess the degree of fulfilment that this provides for the costs involved. This yields the decision document for or against SAP QIM/ERP with QNs. The proof of concept produces a recommendation as to whether SAP meets your requirements, what the pros and cons are for a SAP solution compared with third-party software, which costs are involved and what the next steps are to be taken.
As a SAP QIM/ERP specialist, we provide you with support for SAP-specific design, configuration, production planning and production cutover, both for SAP QIM as well as the quality notifications/integration into SAP ERP.
Our many years of experience with SAP QIM and QM – and particularly with integrating other SAP modules – provide you with expert help for mastering your challenges.
Our implementation work can also include the following services:
- Conceptual design and programming of role-specific QM apps
- Conceptual design and programming of interfaces
- Programming of additional functions
- Programming of additional data fields
- Any modifications to forms as required
We specialise in particular in the development of Analytical and Functional Apps.
This makes it much easier for you to deploy deviation management with SAP as part of a digitalisation strategy.
Even after your deviation management process in SAP goes live, we can provide second- and third-level support services as required. Regardless of whether you need remote service provision or direct, on-site support, our SAP specialists offer a mobile and flexible service. Our wealth of experience means we are familiar with the key questions asked by your users and can guarantee prompt support into the long term.
WHY CHOOSE DHC?
Use our experience as specialists for Deviation Management with SAP:
- Over 20 years of expertise in the implementation of SAP QM and deviation management
- Comprehensive experience gained in a wide variety of SAP ERP implementation projects
- A wealth of pharmaceutical know-how applicable to the handling of deviations and deviation/CAPA management
- Detailed functional and technical expertise related to SAP QIM and QNs in SAP QM
- Incorporation of process-oriented and agile rollout strategies (BPMN 2.0, SCRUM, Design Thinking)
Managing Director & Industry Unit Manager
Life Sciences, Chemie and Medical Engineering
phone: +49 681 93 666 0
CEO and Director Sales & Marketing, DHC Switzerland
phone: +41 44 500 888 7
Learn more about our consulting services for Deviation Management / CAPA with SAP!
WEBINARS AND EVENTS
DHC & LSA Web session (in German)
SAP S/4HANA Transformation and Validation in the Life Sciences Industry
Learn everything about phases for the system transformation (system conversion) of an SAP ECC to S/4HANA with integrated validation.more
DHC web session (in German)
Integrated LIMS with QM in SAP S/4HANA
The web session gives an overview of the different QM functions in SAP and their integration into logistics.more
DHC web session (in German)
Validation of Microsoft Dynamics 365
What validation requirements arise when using Microsoft Dynamics 365 in a regulated environment.more