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Process indicators in quality control

Process indicators in quality control
Process indicators in quality control

Cement and cluten between strategic orientation and operative business.

A structured procedure is essential to establishing a good system of performance indicators. It serves as a basis for decision-making and facilitates prompt responses to new developments.

In most companies – both in the pharmaceutical industry and elsewhere – the quality divisions (quality assurance [QA] and quality control [QC]) are at best grudgingly perceived as necessary, but not as value creators. However, it is precisely these units that function as an important link between the physical product within the value creation chain in pharmaceutical production and its regulatory recognition: Without regulatory approval, the corporate basis of which is crucially influenced by quality assurance and made available as specification documentation for a company, for example, a company may not participate in the market for GMP products – it literally does not have the right to exist in this market. Many companies offer one and the same material or service in varying qualities and at varying prices for GMP and non-GMP markets. The customers are aware of the underlying additional costs incurred and are prepared to pay a higher price for the «GMP».

Bearing this in mind, quality departments can be, want to be and must be perceived as competent, punctual and flexible partners for internal and external customers. Process management is the only way to reconcile quality costs with the high performance of the quality departments. Measurability of the quality processes using key performance indicators is thus crucial1 to ensure that the quality departments focus on their core tasks – ensuring compliance, analytical testing as well as product approval. However, it is not enough merely to collect key data that describe the throughput of the quality units. Rather, an adequate instrument must be created with which you can direct and control the process in the quality unit in the context of your company’s strategic orientation.


Where do you find key performance indicators for your quality unit if you don’t steal them?
Hunting for suitable key figures often becomes the proverbial search for the needle in the haystack. In the German index alone, Google lists around 194,000 hits for the terms «key figures» and «quality control». More in-depth research quickly reveals that key figures are far less firmly established in the quality units than in other corporate departments. In fact, there are very few key figures that describe quality. Rather, quality units collect and monitor the (quality-related) data via other parts of the company. Which figures are appropriate for the quality unit itself remains an open question. So what could key figures for your quality unit look like?


We offer you a structured procedure for the determination of key figures in your quality unit
We’ll give you the bad news first: there is NO single key per- formance indicator for the quality unit. Rather, it is important to describe the work processes using a suitable set of key performance indicators. This ensemble has to do a difficult balancing act: on the one hand, the work processes must be described against the background of the corporate goals and the demands of the various stakeholders. On the other, performance indicators should also drive the implementation of the corporate strategy forward in the quality unit by describing the availability of the success factors.2

Thus, a good set of key performance indicators not only presents the results of the work retrospectively, but offers an active basis for making decisions and reacting to contemporary developments. In this regard we need to ask two fundamental questions: what goals should a quality unit pursue with which processes? And how can the corporate goals be reflected in the processes of the quality unit?


The basic assignment
In a pharmaceutical environment, compliance with regulatory requirements and the absence of product defects must not be perceived as features critical to success that distinguish a company from its competitors. Instead, these factors are part of the routine «hygiene» that customers expect as a matter of course. A mere description that states the «Percentage of rejects» or «Number of OOS cases» is simply not enough. Across divisions, performance indicators such as «First Time Right» are often recorded, which cover the «Percentage of production processes without deviations» or the «Percentage of error-free batch documentation». «On Time», as a level of compliance with delivery dates/deadlines compared to those specified, is an indicator that describes product availability from the weighing to the approval. Thus, «First Time Right» is applied as a measure for avoidable rework and «On Time» describes retrospectively how satisfied the customers should actually have been with the delivery of the ordered products and services. Only the combination with upstream early indicators and data analysis from quality perspective enables us to trace problems back to causes such as

  • quality of the specified documentation (topicality, compre- hensibility, usability and complexity),
  • educational and training status of the employees,
  • availability of suitable resources.

In quality assurance, the indicators «Percentage of (over)due SOP reviews» or «Schedule adherence/target fulfillment» with regard to the training target derived from the training requirements are useful for this purpose. The evaluation of the «Quality of the specification documents» should not be left merely to a periodic review by just a few participating reviewers.


Integrating your criteria for success
Plants grow best when you give them what they need the most: light, carbon dioxide, water, nutrients and trace elements. The addition of factors that are not required does not necessarily lead to increased growth of the plants, and in the worst case can even cause damage. The knowledge of what is lacking is essential. The same can be said of the business processes in your company. Suitable key performance indicators show you not only if a process works, but they can provide you with information about shortcomings that may exist within the respective process. If innovative strength is the criterion for the success of your company in the market, this applies all the more to quality control. It can be useful to include the valida- tions of analytical methods for new products in the set of performance indicators. This not only lets you describe the performance of a laboratory; such an indicator can also be a valuable early indicator of future sales with the associated products: today’s validation forms the basis for the (routine) analysis of the products manufactured tomorrow – at least in the following clinical phases. Appropriate indicators can help to detect bottlenecks at an early state and enable you to provide adequate resources in a timely manner.


You benefit from our structured procedure
We offer you a structured procedure for the determination of key performance indicators in your quality unit. The procedure is divided into nine main steps:

  1. selection of the processes to be reviewed
  2. definition of the process goals against the background of the corporate strategy
  3. reconciliation of the process goals with the owners of the standards
  4. establishment of the relevant criteria for success
  5. establishment of measurability for the relevant criteria for success
  6. implementation and installation of the associated key perfor- mance indicators
  7. collection of the process performance indicators
  8. assessment of the effectiveness and controllability of the processes
  9. implementation in the daily routine: repeat step 8 regularly.

Take advantage of our experience to develop a suitable system of key performance indicators for your quality unit. The Chemgineering Business Designers offer your company more than just the documentation of the usual key performance indicators with regard to productivity, speed and quality. Together with you, they model the critical success factors of your processes in your quality unit with suitable performance indicators, enabling you to control your processes proactively.


1   Rengers, J. U. in Chemgineering Newsletter 58 (2010)
2   Nørreklit, H. in Management Accounting Research 11 (2000), 65 – 8


Dr. Thorsten Ebbinghaus|Senior Consultant|Chemgineering - The Business Designers



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