Featured Book of the Month:

Title: Customer Satisfaction: Tools, Techniques and Formulas for Success 

Author: Craig Cochran

Publisher: Paton Press

Notes: Customer satisfaction is the single most important issue affecting organizational survival. Despite this fact, most companies have no clue what their customers really think. They operate in a state of ignorant bliss, believing that if their customers were anything less than 100-percent satisfied they'd hear about it. Then they are shocked when their customer base erodes and their existence is threatened.

You can order this book from internal-auditor.com at: http://www.internal-auditor.com/books.htm

This Month's Feature Article

One of the new aspects of ISO 9001:2000 is the process approach. Last November, we looked at Process vs. System Audits. In that issue, we discussed what to audit, but we didn't particularly look at what evidence to look for. Since that time, process audit evidence has taken on greater emphasis, especially with ISO/TS 16949. 

A process can be defined as a managed activity that uses resources to transform inputs into outputs. (ISO 9001 Clause 0.2). Clause 4.1 goes into detail of how we must manage our processes. and 4.2.2 requires a description of the interaction of the processes to be in the quality manual. So, in order to audit these things, the internal auditor must rely on auditing the process. To do that, the internal auditor must be able to identify the evidence that will determine whether the process, and its management is compliant.

 When examining the process , we ten to categorize the process into one of three parts:

• Process Inputs

• Process Operation

• Process Outputs

Let's look at each category and discover what evidence can be applied to each part. Before we do, let's review the three ways to obtain objective evidence. The first method is through observation, here the internal auditor watches performance/behavior to determine if the operator is following the instruction. The second method of obtaining evidence is through examination. That is, you look through documents or records. The third method is interviewing. You ask questions, and record answers. 

Process Inputs

This is the start of the process. It may begin with a customer request, or with the output of an earlier process. As internal auditors, we need to be able to identify the process inputs. Our process descriptions should contain this information. Most processes will be linear, so the outputs of one process will be part of the inputs to the next. However, not all process inputs will be from the previous process. If the input is the output from the previous process, examine how it is "handed off". What are the steps in transforming the output into an input of the subsequent process. 

One good way to look at a process for inputs is to apply the standard to each process. That is, to look at the major parts of the standard and how they apply to the process. for example, Clause 4 covers the QMS, document control and record control. From these parts we can determine what documents, records and other QMS requirements apply to the process in question. We then consider Clause 5, Clause 6, etc. The primary method of obtaining evidence here would be through examination., with some interviewing. 

One of the primary pieces of process input evidence will be the process description, or process map. The process owner and operators should also be able to identify the process inputs. It would be expected that the process owner would be considerably more aware of process inputs than process operators, and would be the best source for information related to inputs. 

Process Operation

This is where the transformation occurs. Most of ISO 9001 and ISO/TS 16949 deals with this part of the process, and this is probably where most of your audit will occur. The process description, or procedure, should identify the steps in performing the process. The process operators will undoubtedly use some form of work instruction, be it as simple as a print, or a control plan (these would be considered inputs). This can be verified by observing the process in action, and interviewing the process operators. Do the process operators follow the process plan? do they know how to react in response to certain circumstances. 

Many internal auditors use a checklist, based on the process flow diagram for auditing the process operation. Understanding the inputs is also critical in determining process operation. Are the operators following the process for product identification, measuring, and handling nonconformities? These are just a few of the questions that must be answered. This is why auditing the process will typically be the bulk of the audit. 

Process Outputs

The output of the process comes in multiple forms. The form that is of greatest concern, of course, would be the product. In some cases, this product will go to the customer, however, in most cases, this product will be the input for the next product in line. Other outputs include any required forms, charts (such as SPC), and other paper work (such as shippers). Once again, the process description should indicate what the process outputs are. Once again, the primary method of determining the evidence will be through examination. 

Also, do not forget to examine how the output is handed off to any subsequent process, how the output is verified/validated and what records are maintained to show output meet input requirements. 

Summary: 

Before auditing a process, the auditor needs to have a certain level of understanding of the process. As a minimum, process inputs and outputs should be outlined and available for the auditor prior to the audit. The auditor must make sure that all inputs are recognized and that the process plan is adhered to. Process outputs need to be verified and compared to requirements. 

Process auditing is an integral part of process thinking. If we are to look at our operations from a process standpoint, then we also need to audit the operations the same way. 

As always...Good Auditing!

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www.mmtc.org 

Q – Must all process evidence be documented (as with a record)?

A – No. There are three ways to obtain objective evidence: Observation, Examination and Interviewing. Most process audits will involve all three methods. Although documented evidence is probably the most sure way of proving the process, there are always steps in the process that do not need that level of "proof". Otherwise, we would spend more time filling out records than performing the work. The tough thing for an auditor is to determine when a record is required and when one is not. 

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The reports we are getting from the field concerning transitioning from QS 9000 to ISO/TS 16949 are rather interesting. Companies that have been registered to QS for over 3 years are reporting that the transition audit centers around three things. First and foremost is process identification. All have reported they had some sort of graphical process map showing the overall process, with significant processes having their own maps. The auditors spend a considerable amount of time on the process identification, including inputs and outputs.   Related to this, the auditors also spent time on the metrics used to monitor and measure the processes. They also looked at competencies and how competence was assured. 

Of course, this does not mean that your registrar will focus on these things, but all are important to maintaining an effective QMS, and time should be spent to ensure your system works as planned.

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ISO 9001:2000 Clause 4.2.4 Quality manual

"the organization shall establish and maintain a quality manual that includes
c) a description of the interaction between the processes of the quality management system. "

You are required to have a description of the process interaction in your quality manual. Although the most common approach to this is through a process map, a process map is not required. Regardless of what type of description is is used, the description must adequately describe the interaction between the processes. How do the processes interrelate? If one process is changed, how will it affect other processes, both up and down stream? How will changes affect parallel processes? The key is to understand that processes are interrelated and co-dependent on each other. Your description needs to reflect this.

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January 2002’s question:

As part of the audit, you must determine if the quality policy is understood through out the organization. To determine this, you decide a random sample of persons exiting the break area. The next five people leaving the break area will be questioned. The first two go quite well. The third person is someone you know that has a reputation of being anti-company. You decide to ask anyway and the response is that he is sure the company doesn't have a quality policy. He has never heard of one, and has never been trained on a quality policy. You record his response and continue. The last two are also positive.

The answer:

The heart of this case study centers around data influence and conducting an audit which is impartial and objective. It is easy to simply disregard the person's answer and write it off as corrupt data. some organizations and some internal auditors do this, with a clear conscience. However, in this case, you already decided to ask the question. Now what do you do with the answer? What we want to find out is whether the quality policy is understood and implemented though the organization. Yet we also want a fair and useful audit. We must balance the needs carefully. In this case, to not consider the person's answer would add bias to the audit. After all, we are automatically assuming the person is giving us wrong information. However, if you write up a nonconformance, then the truth will eventually come out. 

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Giving Thanks

Each November, this nation takes a moment to reflect and give thanks. As internal auditors we, too, should reflect on what things we have to be thankful for. Internal auditors have a though job, especially considering that most of us have regular jobs to do, and internal auditing is just another "hat" we wear. Many of us are "draftees" into the internal auditing, that is we didn't volunteer for the extra work. Because we write nonconformances, we tend to get static from time to time. It doesn't sound like we have a lot to be thankful for. But consider this. We tend to have a different view of the organization. We see more "big picture" stuff. We ten to see more of other operations, and with process-based auditing, we have a better chance to understand other processes, than our own. This adds value in our employment. We can cross-train for other jobs better than most. 

We also should look back at all of the nonconformances and observations we've written to see what positive changes have been made to the organization as a result. We should be able to take pride in our work, and in the outputs. More importantly, we should be able to look toward the future and anticipate what positive changes we can influence. Overall, we should give thanks that we are trusted enough to verify the QMS and use that trust to march onward. 

Dave

...Good auditing!

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