Chris Paris is a consultant, as am I, so I speak from experience as does Chris. I have over 30 years as a consultant before retiring earlier this year. I have performed many internal audits or pre-audits for my clients. In addition, I have done a number of CB audits that had help from other consultants through the years. There are a number of consultants out there that I would highly recommend without hesitation. But there are also the consultants out there that do not provide good advice or service to their clients and thus degrade the systems. It is those who do not do a great job for their clients that this article is focused on. No names are used in order to protect the good ones.
Let me start with a focus on the lack of experience and the lack of knowledge to do the job. In my years as a CB auditor I have given several major non-conformances to the clients because they got bad information from a consultant, or to a trainer, they hired to help them. There is no particular order to the following examples and the shortcomings of the consultants involved.
In one case, the trainer had told the client they did not need to justify the “not applicable” sections of the standard. They were told that went out with the new 2015 standard. We looked at section 4.3 of the standard and I asked the client how their trainer explained the following or how they were told to address it: “The scope shall state the types of products and services covered, and provide justification for any requirement of this International Standard that the organization determines is not applicable to the scope of its quality management system.” The client said they were told they could ignore that part. The client manufactures product to their customer’s prints so they had determined design did not apply. They were correct in the determination and they only needed to indicate the justification for it.
Several times I have run across clients who were told to indicate an exclusion (under older versions) and not applicable in the 2015 version for design. Clearly the consultants involved did not know what they were talking about. The consultants indicated that if they talked to the customer about a project, they designed the project as to what was to be done to meet the end goal, they did not do design because the client had given them what the end product or service should loosely do or be done. That is like me telling you I want a car with 4 wheels. It does not say how big or small or color or speed it can go, or how many windows or seats if any. If you tell me you want to sell me a Cadillac or a VW both could meet my goal of a car but actually, I do not want either one. I had one who tried to tell me that Dell does not design computers. I tried to ask who they thought designed Dell computers and they said the person who buys it. If Dell does not design all the parts to work together (because I clearly do not know what all needs to go with what) then who does the design?
Calibration (or control of inspection, measuring, and test equipment) is another big issue that not only consultants but many CB and AB auditors have no idea about what is required, I am saving that for a later article that will also encompass the control of ISO17025 through the years as well as ISO17025 registered companies or the lack thereof. I have had consultants tell companies that they don’t need to treat their calibration sources as outsourced processes. While this may seem like a stretch it is not. If the company is depending upon the accuracy of their equipment to ensure product meets customer requirements then the equipment is an integral part of the process and therefore must be considered for control under both the old standard and in the new standard. What I have seen through the years is not just companies but their consultants and auditors may not know what is required. The fact that a calibration house has a certificate from a recognized AB does not mean the calibration is correct or the certificate with them are correct. Please read the next article I submit to Chris regarding calibration and its many flaws. It also includes information on why mistakes occur that can cause many failures in products and likely contributed to failures of some of the products Chris has mentioned along the line.
I have seen overkill as well us underdeveloped systems. Both can have a negative effect on the QMS of a company. Too much documentation and especially with too much detail can lead to issues. With too much detail you have employees who find it so overwhelming they don’t read it or they just drift away from the documented process. Years ago, when I was an engineer at an internationally recognized high-tech company, the procedures were 10 and 12 pages long. So much unnecessary detail and not well organized that you could get lost just trying to figure out what to do. In reality, a 3 or 4-page well-organized document worked fine after a rewrite to it. I have seen documentation so extensive (over 200 documents) that no one read or followed. Why? What good does it do especially when the employees may not have ever seen them or read them or could even find them?
When I was on the advisory board of a CB, one of the members came in complaining about 2 of the NCRs they had just received from their CB audit. The first was because they had a procedure that said they could only use black ink to sign their documents. Someone had used a red ink pen. I asked why the black requirement. He said their consultant told them that they needed to use only black. As always, I asked him where the standard said it had to be black. He said he had just listened to the consultant. I ask if there was any other reason for the black and was ink required. He went back and they said it had to be ink of any color.
The second NCR was for photocopying forms. Their procedure (again because the consultant told them they had to) said all copies need to be made by this one person in the front office. The problem was she worked days and production worked 2 other shifts that she was not available for. Suggestion: make the shift supervisor (or their back up if gone) be responsible. In their case an off–shift supervisor had made a bunch of copies from the last copy they had in production and they need more.
Under documenting can be an issue as well. A new person may need the documentation to do a process that may be done one way for one customer and another way for a different customer. If there is no documentation, how is the new person suppose to keep track of what to do when? This may also be important for someone who takes over a job once or twice a year when the primary person is on vacation.
Some consultants are good at working with the client in determining how much is needed and how it should be written for each specific client. In other cases, I have seen a “quality in a box” approach. In way of explanation, the consultant has developed a QMS with a set of documents that they hand to the client to use as is or with small modifications if the client is educated enough to see what and how to change them.
I was in one company that had gotten a “quality in a box” system. The documentation looked great when I got it for review prior to a pre-audit of the company. When I got on site for the pre-audit and asked questions about parts of the documentation the company employees did not understand what the documents said and did not do them. This was before I even became a consultant and was trying to qualify the company as a supplier. Needless to say, I would not approve them.
Having forms to choose from can have advantages and is most effective when the consultant works with the company to choose the one most fitted for that company and the processes that the company does. It can also be very effective if the consultant has designed them to be more generic to fit any industry. When I started, I had a contract with a group of companies. When I signed on, I was told they all worked the same. Fool me once applied there. Only once did I agree to something like that. They did not work the same and therefore they needed different procedures and forms. They were all the same type of industry for the most part but each one was different in some way or another from the others. No two were able to use “quality in a box”.
Recently I was in a company that used a consultant to help upgrade their system to the ISO9001:2015 version. The consultant understood what they did and did their internal audits for them. The consultant made sure the owner/president could find things in their documents. But no one else could. The consultant went away as did the president/owner who sold the company. No one could figure out how to do the audits or where to find things in their documentation. If it is not designed so all who need to follow the documentation and/or perform the internal audits, then who is the documentation written for? As their prior CB auditor, I had taken a lot of time earlier in the year to make sure all requirements of the standard were met but even I had trouble finding it as did the prior owner during their audit. If the client can’t figure it out (and I mean all involved within the company) then what is the point of the documentation? It then sets the client up for non-conformances but worse yet may cause a system or process issue that affects their customer/s.
The result of lack of knowledge, over documentation, and under documentation on the part of the consultant can and does lead to negative results. I have to wonder how many of the issues Chris has and continues to provide us with may start even farther back in the process with the consultants or trainers that were used to set up the systems. Since often times the consultants also provide part, if any, training on effective corrective actions we may never know if they played a part in these.
I have seen consultants who have told their clients that you do a corrective action only if it gets to the customer. Otherwise, any non-conforming product or service caught before it gets to the customer is just a preventive action and does not need a full analysis of the cause and effective implementation of actions taken. I have seen trend analysis to be almost non-existent in some cases and the consultant got upset when their client got a major for not doing trend analysis to see the bigger picture. Could this be because they do not understand or see the trends? Maybe that is why the companies continue to have bad product or service or rejects or waste.
As I said when I started, there are all levels of good and not so good consultants. If a company is going to choose a consultant, they should interview several and ask questions just like interviewing someone they hire. Maybe in improving the quality of the consultants the clients will have better systems and we will all benefit from improved products and services.