PROCESS APPROACH

A process is defined as a “set of interrelated activities that transform inputs into outputs.” ISO makes extensive use of this definition. First, a process model is used to define the relation of the various elements of a … management system. The process model is also used to further define the relationship between inputs, value-added activities, procedures,

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measurements, and outputs. The inputs include materials (ingredients or components), machines, time and finances. Procedures may or may not be documented (Chapter 6). Monitoring and measurement opportunities are used to provide feedback and feed- forward information on the process and product quality (Surak 2001).

Figure 5.2 describes the relationship between process inputs and outputs. PROCESS AUDIT

Process audits vs. element-specific audits were mentioned briefly previously in rela- tion to scheduling. In scheduling the audit and maintaining the audit schedule or pro- gram, the combination of process or area audits and specific element audits should be discussed.

Process audits have proven to be much more efficient and value-added than ele- ment-specific audits, especially in a mature system. Think of the system as having processes within a process. An organization is defined as a collection of processes, all of which work together to transform inputs into outputs. The key point to remem- ber is that all processes have inputs that must be met in order for the process to suc- cessfully meet its outputs (goals and objectives). The output of every process is the input to another process. The output must meet its objectives and be successful for it to be a successful input to another process. When preparing for a process audit, it is best to divide the inputs into six different focused parameters: people, equipment, environment, measures, methods, and materials. Russell (2003) when applying these parameters, ask the following question. This question can and does lead to a success- ful gathering of information and the identification of related trails that may not have surfaced otherwise:

What are the outputs of the process or area of responsibilities? In other words, what are the objectives, and what measures are being used to know if this has been accomplished successfully? Once the goals/objectives and an idea of the measure of success are determined, then ask about related inputs. Figure 5.3 provides a sampling of process audit questions.

Process auditing is an excellent audit tool. It is recommended that every organiza- tion move into the process audit approach as its management system matures. The parameters, such as those mentioned earlier, are just one of many methods applicable for learning process auditing.

There are many other good ways to approach process auditing. One very popular tool that is good for internal auditors is the turtle diagram. The use of the turtle diagram

Input Process A Output

Input Process B Output

FIGURE 5.2 Process relationship. (From Surak, J., International Organization for

Standardization ISO 9000 and related standards, in Schmidt, R. and Rodrick, G., eds., The Food Safety Handbook, Wiley, New York, p. 707, 2001.)

creates a picture of the process which includes related system elements along with related process inputs. Figure 5.4 is an example of the turtle diagram that is then completed during the audit preparation stage. It can also be maintained as a refer- ence document for future audits although content may vary depending on the scope of the audit.

As with every tool, there are advantages and disadvantages; thus, it is recom- mended that the audit program owner review and learn its application, and then share with the audit team to determine its role in the organization’s audit program.

It is recommended that management also review other sources such as textbooks and workshops focusing specifically on process auditing. Once the process auditing concept and the best way for the organization to apply it to its internal audit program are understood, then it is recommended that training and practice audits be per- formed. It takes practice to get used to the concept, but this type of approach used long term, is invaluable to the management system overall.

Keep in mind that the questions that may relate best to a specific area, process, or element are going to vary depending on the system itself, the organization, the auditors, and the scope of a particular audit. It is important that the auditors, in their preparation stage, do not worry about getting the questions right or missing some- thing critical, but focus on preparation, experience, and common sense. Once this confidence or comfort level is achieved, then effective audit activities fall into place for the audit. Each audit is different. It is the combination of all of the audits that result in an effective and value-added internal audit program.

a. Are people involved? b. Is specific equipment required to complete the process? c. Are there any environmental considerations? d. Are materials needed? e. Are there measures or standards? f. Is a specific method required?

FIGURE 5.3 Process audit questions.

Equipment/ facilities Inputs Outputs Performance indicators With whom? Process name Support processes Instructions/ procedures

FIGURE 5.4 A basic example of a turtle diagram. (From Micklewright, M., Auditors, turtle

diagrams and waste, Quality Digest, 1/8/2007. http://www.qualitydigest.com/inside/quality- insider-article/auditors-turtle-diagrams-and-waste.html.)

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