Increased requirements for result and process orientation

The third part of this series of articles is concluded by notes on the handling of knowledge in connection with process management. The supplementary tools presented in this article represent possibilities and suggestions for implementing the standard requirements, but do not claim to be the only possible ones or to be mandatory in this form.

What applies to the QMS?

"According to the scope definition, the organization shall ensure that context, interested parties, and products and services have been considered" (NC 4.3.5.). Previously, the scope and any exclusions had to be defined as part of the QM manual. Recently, the definition of a scope is more precisely specified: For example, organizational parts, physical locations, etc. can be delimited. Within the delineation made, all ISO 9001 requirements are to be applied as far as they are applicable (no free exclusions). The documented scope shall include the type of products and services covered and shall include justification for any standard requirement that the organization classifies as not applicable. When defining the scope, the contextual issues, i.e. relevant internal and external issues, the requirements of identified key interested parties (NC 4) and the organization's products and services shall be considered.

Processes for results

The new standard requirements for process management hit an important point of competitiveness. The current economic context forces companies more frequently to adapt processes at shorter intervals if constantly changing requirements are to be successfully met. What is required in terms of an effective and suitable QMS in terms of processes is to be determined by the company itself. The NK 4.4.1 provides precise guidelines and explains how processes are to be equipped, taking into account risks and opportunities, so that they achieve full effectiveness in terms of achieving the intended results of the company.

Documented processes help the company to implement effective process management. Documentation must now be viewed with a much stronger focus on benefits and not as a rigid obligation. Documented process information (process documents) must be maintained at least to the extent that it is able to support the implementation of the processes in a suitable manner. The amount of documented information depends on the expected risk and efficiency-reducing factors such as misunderstandings, sources of errors, higher expenses, communication deficiencies, etc. In the introduction (NK 0.3), the standard also contains a helpful schematic representation of the elements of an individual process, including the interactions of its elements and the control points required for monitoring and measurement.

Managing and improving processes in the control loop

The stronger result and benefit orientation of a QMS is expressed in particular in the improvement cycle of process performance and (QM) system performance according to the PDCA model (Plan, Do, Check, Act). This applies in particular to the (business) processes.

"Increased emphasis on quality objectives related to processes ensures that the organization quantifies and consistently meets the needs of service recipients, strives for effective process performance, and guides its process improvements based on evaluation of data and information" NC 6.2.1. Guidance for this is provided by the standard's requirements related to process maturity (NC 4.4.1.). The following specifications are required:

• Sequence and interactions of the processes, 
• Input, (implementation) and results,
• Responsibilities and Powers,
• Availability of resources,
• Risks and opportunities,
• Effect and control of the processes, 
• Methods for monitoring, measurement and evaluation,
• Opportunities for improvement.

Sequence and interaction of the processes

"Consistent and predictable results can be achieved more effectively and efficiently when activities are understood, managed and directed as interacting processes - functioning as a coherent system" (NC 4.4.5.1.). Such a system of processes is called a process architecture or process landscape. One or more business processes (BPs) ensure outcomes for external customers. Effective GPs are identified by analyzing the needs and expectations (requirements) of customers. If all customers have roughly the same requirements, one GP is sufficient. For groups of customers, each with vastly different service needs (e.g., corporate finance vs. a bank's youth savings account) or with vastly different complexity of requirements (e.g., standard vs. special project, standard machine vs. special equipment, etc.), the obvious choice is to establish multiple GPs (which does not yet mean that they use different resources). Support processes run from internal customer requirements to their fulfillment. The management processes have both external (e.g., capi

As a link between strategy and operational processes, a concise representation and the mapping in IT should take place.

The strategy should be presented in a concise manner and mapped in the IT system. As a link between strategy and operational processes, there should be a concise presentation and mapping in IT.

Input, (implementation) and results

"Process and risk-based planning and control should ensure that the outputs of planning are suitable for the organization" (NC 8.1). Various methods exist for the representation of processes, e.g. flowchart, BPMN (Business Process Model and Notation), swim lane representation etc. At the operational level, the use of checklists should be examined, which can serve as a default and verification document if required (or for IT-supported workflows). Procedural instructions provide further support.

Responsibilities and powers

in relation to appointed process owners and employees can be recorded, for example, in a responsibility matrix and/or as authorizations in the workflow, information, planning and control systems.

resource availability

The resources required for the processes must be defined and made available. It must be clear what kind of resources are needed, where there are any limitations and what is therefore sourced externally. The planning of resources refers first and foremost to people, infrastructure, process environment, and it also specifically includes those resources that are needed to measure and monitor the processes and the quality of products and services: "Through a systematic analysis and evaluation of internal resources, bottlenecks can be avoided and, if necessary, external resources can be evaluated and made available in good time" (SC 7.1). This may mean, for example, that staff skills are recorded in competency matrices, also as a basis for their further development. Capabilities and performance limits of facilities and infrastructure should be similarly known. Selection criteria for external providers, "make or buy" evaluations, etc., and their documentation serve as evidence.

Risks and opportunities

A description in a process sheet contains, in concentrated form, details of the process owner, regulations and guidelines to be observed, particular risks, methods and IT tools used, inputs, outputs and interfaces of the process, suppliers to the process, (internal) customers and, in particular, process metrics with their targets for measuring and improving process performance (see also the management review in the June issue of this magazine).

Effect and control of the processes

The ISO 9001 requirements on the procurement side cover the 3 categories "products, services and processes", which are procured via external suppliers and which contribute to the company's performance. Here

• the ability of the company to continue to deliver compliant products and services to its customers (value proposition) and to achieve customer satisfaction and/or loyalty must be maintained,
• processes or functions provided by an external service provider must remain under the QMS control of the company,
• the nature and extent of control of those processes involving external providers and their relevant outcomes must be risk-based by the company (impact on ability to deliver intended outcomes).

"Through risk-based control of external providers, the organization thus also ensures that customer requirements can be met on a sustainable basis." (NC 8.4.2). Supplier audits, performance controls, validation/verification certificates, etc. serve this purpose.

It is advantageous to introduce risk (and opportunity) oriented performance measures for the processes.

It should be noted that the control of production and service provision also suitably includes post-delivery activities. These are, for example, services

• which are based on customer requirements and/or performance promises (warranty, maintenance, recycling, returns, repair, communication, etc.),
• which are based on legal/regulatory requirements (e.g. control tasks, product monitoring, recall capabilities, information and reporting obligations, etc.),
• which are decided on a risk basis in order to avoid undesirable consequences in connection with product or service use, 
• which are decided on an opportunity-oriented basis in order to position/differentiate themselves through special (service) achievements, 
• include other customer services (feedback, complaint handling, customer support, loyalty programs, etc.).

Methods for monitoring, measurement and evaluation

It is advantageous to define risk- (and opportunity-) oriented performance measures, key performance indicators, etc. for the processes, specifying the measurement occasions, frequency and measures in the event of deviations in the process sheet (see above). In many cases, the measurement results are clearly summarized in a process cockpit. A traffic light system allows a quick overview of the performance status of all relevant processes. Last but not least, the results serve (in part) as a basis in the process perspective of a balanced scorecard. The basis is the determination of the measurement method used per process.

Opportunities for improvement

With the (prioritized) measures such as internal audits of processes, process analyses, training, improvement workshops, etc., the (PDCA) control loop is closed. The permanent improvement of processes is supported by methods such as brainstorming, Ishikawa diagrams or process FMEA.

What do we know and how do we use our knowledge?

A challenging innovation of ISO 9001 is the required systematic handling of the organization's knowledge. Knowledge management is clearly in focus and serves successful and efficient processes and the achievement of intended QMS results. Effective use of knowledge works better when

• the knowledge required for the key processes is suitably defined, maintained and optimally accessible, 
• changing requirements and decisive trends are regularly observed in order to have additional knowledge, necessary updates, etc. ready for use in good time.

"A systematic approach to knowledge of the organization from

• - internal sources such as intellectual property, experience gained, learning from mistakes or successful projects (PDCA!), capturing undocumented knowledge, specialist know-how in the organisation as well as from 
• external sources such as standards, science, conferences or in exchange with customers and suppliers enables the organization to maintain and increase competitiveness. " (NK 7.1.6. )

In addition to the increased documentation of experience knowledge in the process descriptions and work instructions, from FMEAs, etc., easily accessible collections of information, e.g. in a media library or in knowledge databases, and a regular exchange in working groups (e.g. ERFA or in improvement project groups) can contribute.