Risk based quality management

Risk based quality management (ISO 9001:2015)

The new version of ISO 9001 : 2015 challenges organisations in various ways. Although it keeps the focus on process orientation, collaborative knowledge management, risk-orientation and the integration with other norms and regulations require modifications to the existing or the introduction of a new QM-system.

Be well prepared to the new release of ISO 9001:2015 with the holistic C.O. Quality Suite of C.O.S!

Risk orientation

Various phases and processes of product/service lifecycle that at first define and later contribute to the quality. The key concept of a risk based approach is to avoid (commercial) impact of poor quality at all stages and in all processes and allocate the quality management resources, where they are most efficient.

Magnitude of impact times probability is the standard measure of risk which we applied also in our risk map and catalogue to help organisation to master this challenge.

Product definition and Market research

Estimating tomorrow’s demand and defining the product strategy to meet the customer’s expectations is a key to success. To stay successful all characteristics of any product must be defined developed using the creative potential of the organisation and its stakeholders. Stimuli and innovation can originate from various sources beyond marketing and engineering department today.

  • Employee ideas
  • Customer complaints
  • Social listening – evaluating the flavour of rumours, chats, blogs gives long range insight to the product/service consumer community and provides warn signals way ahead of disasters
  • Internet Intelligence – observing own product performance in online trading platforms

Quality management feeds observations and deficiencies along with improvement potential and innovations back to the early product invention stage. Furthermore, a vital quality management function monitors technical (costly construction process, poor design, …), commercial (warranty claims, call back initiatives, …) and marketing risks (like unreachable customer expectations) also at an early product life cycle stage to avoid and mitigate them the earlier the more efficient – before reputation and brand are spoiled or a drop in turnover sends the signal from the market place.

Target costing allows a first specification of the demand. The product characteristics relate to risks and costs. Quality risks are detected, hedged, mitigated or avoided bevor they materialise, if addressed in this early stage.

Product development

A short time to market and the trend to a broad variety and product individualisation poses enormous pressure to the design and construction department. An integrated information base provides all stake holders insight to the project progress and documents all quality risks and control measures at an early stage.

Results of measurements for prototypes should be stored in structured and consistent way to allow a transparent analysis and reporting, if any undesired features occur after market introduction.

Operations

During production or service delivery the quality risks can be monitored under various aspects:

On the input side the quality level of the supplies must be monitored. Goods reception beyond the commercial focus of an ERP-system avoids risks originating from poor supplier quality.

At the process stage the own production results can be measured and results documented in a corresponding module. Knowledge of the workforce can be tracked in a training module. The reliability of the equipment and assets is addressed by a gauging and maintenance plan.

Audits and employee ideas can stimulate new quality enhancements at all stages.

The organisation’s output can be controlled by various ways. Product specifications and service levels as contractually agreed must be available to evaluate the commercial risks. However, analysing customer returns and complaints is not enough anymore. Post sales satisfaction should include listening to social media and looking at durability information and customer expectation on online platforms.

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  • Goods reception helps to monitor the quality of supplies commercially and technically beyond the scope of an ERP-system.
  • Analytics management collects your testing results.
  • Complaints management feeds customer satisfaction back to your organisation.
  • Social listening is your short range radar for more reaction time in case of problems, disasters ,or call backs while the long range radar observes future customer expectations.
  • Training tracking maintains the knowledge of your workforce vital and quality-aware.
  • Gauging and maintenance management keeps your equipment in a shape that enables continuous quality output.
  • Contract management monitors the contractually agreed quality and service levels and the commercial implications.
  • Audit tracking allows to systematically collect all follow up findings.
  • Issue Tracking tracks all initiatives (quality related or not) of the organisation and manages their timely execution.

Strategic process orientation

Management system

C.O. Documents provides processes and documents to structure the manual on an integrated platform. Visual navigation by process maps and process ownership keep the structure transparent to all user groups. Process owners are enable to take responsibility through a clear monitoring and reporting scheme.

Project management embedded

A vital organisation reacts to external change by adapting internally to the new situation. Steering and tracking these adaptions requires a flexible centralised tool that is easily available to everybody.

Quality relevant information

Passing information from one process / organisational unit to another in a structured manner requires a common platform of all quality related modules and data with a solid notification engine that knows your structure. Furthermore, the importance of information to the recipient must be reflected in the communication channel.

Integration

Management system

Multi-norm compliance is a common requirement for larger organisations today. Therefore, C.O. Documents includes a “norms & regulations” module to refer all content accordingly. Thus, the relationships of any of the internal documents to all respective norms is maintained and can easily be reported.

Module integration

All quality related tasks throughout all modules can be assigned their cost, which become then reportable. Moreover, interfaces between audit management, idea management, customer complaint, gauging and maintenance and the issue tracking module or goods reception and analytics module allow to follow up all (risk mitigating) projects on the same platform.

E.g. a customer complaint can lead to a counter measure in the construction, an audit can report a process deficiency…

Collaboration

Collaboration can only function if

  • no redundant data produces inconsistencies,
  • (only) relevant information is shared,
  • responsibilities are transparent,
  • communication channels are defined and
  • timelines are monitored.

No barriers should block the quality information stream. On the other hand, a modern quality management should avoid to contribute to today’s information overkill, if it wants to cross the threshold of perception. The information should flow in the organisation traceable, secured and controlled.

A common database and a web-interface integrates all modules of the C.O. Suite. Access controls, encryption, certification of software components provide a secure environment that is open enough to enable effective collaboration, but avoids information leaks or overkill.

Tablet, Smart- or I-Phone: delivers the quality information according to the information needs directly to the work place.

Search and navigation functions simplify the usage and lead directly to the relevant content. Superfluous complexity is filtered to boost the acceptance of the system.

Common patterns from all modules in the content or the metadata are easily retrieved. Thus, the quality risk can be detected and mastered throughout all business processes.