DEVIATION MANAGEMENT & CAPA

Identify quality deviations and
develop measures to avoid them!

SAP Qualitätsmanagement

DEVIATION MANAGEMENT AND CAPA WITH SAP QM

No business process runs perfectly all of the time, which means quality deviations are part of day-to-day life. Deviations are not just part and parcel of production and logistics, however, but can also affect customer complaints or be related to vendors. Accordingly, every company needs processes and tools that can identify quality deviations early on when they occur, so as to track them, rectify them and – last but not least – avoid them in the future.


Deviations must be recorded and documented as part of a detailed description of the non-conformity/defect. Once the quality-relevant deviation has been confirmed, a detailed root cause analysis must then be conducted.

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 digitalises CAPA processes in the SAP Quality Issue Management (QIM) module or with the help of quality notifications (QNs) in SAP QM. The advantage of the two solutions is full integration with SAP ERP, and therefore the avoidance of redundant data as well as error-prone interfaces.


DHC CONSULTING SERVICES FOR DEVIATION MANAGEMENT / CAPA WITH SAP

Consulting

Business Case
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.

Scoping
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.

Implementation

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.

Services & Support

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)

 

Germany
Matthias Bothe

Managing Director & Industry Unit Manager
Life Sciences, Chemie and Medical Engineering
phone: +49 681 93 666 0
email: matthias.bothe@dhc-gmbh.com

Matthias Bothe, DHC GmbH
Switzerland
Carsten Buri

Director Sales & Marketing
phone: +41 44 500 888 7
email: carsten.buri@dhc-ag.ch

Carsten Buri, DHC AG
Request information!

Learn more about our consulting services for Deviation Management / CAPA with SAP!

WEBINARS AND EVENTS

08. November
German Webinar

Prüfmittelverwaltung und -überwachung mit SAP

Vorstellung der in SAP integrierten Prüfmittelverwaltung mit allen Funktionen für die unternehmensweite Verwaltung betrieblicher Prüfmittel

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12. November
English Seminar

SAP: Validation and GMP Compliance

Seminar with speakers from DHC GmbH, organized by Concept Heidelberg on behalf of the ECA Academy, Steigenberger Hotel Berlin

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22. November
German Webinar

Validierung von SAP S/4HANA Enterprise Management

Neue Compliance Aspekte und Wege zu SAP S/4HANA sowie Vorstellung der prozessorientierten, risikobasierten DHC Methode auf Basis von SAP Activate

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29. November
German Webinar

APQP, FMEA und PLP mit SAP QM

Vorstellung der verschiedenen SAP Werkzeuge zur Abbildung von APQP und Darstellung von SAP PPM, FMEA, Kontrollplan, Prüfplan und Qualitätsmeldung

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06. Dezember
Webinar

SAP QM als integriertes Laborinformations- und Managementsystem (LIMS) in der Life Sciences

Vorstellung von LIMS-Funktionen des SAP QM sowie Integrationsaspekte zu Einkauf, Lagerung, Produktion und Vertrieb

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