If you’re in the Quality Management field, you might not be looking forward to this question.

There are a couple of different approaches. You can mention that you work in “Quality” in the “enter specific field here”. There’s a good chance they will look at you kind of confused and not ask any follow-up questions because it sounds a bit boring (90% success rate, personally). 

Or you can try to actually explain what you do. Now, there are a lot of different careers in Quality Management, so this will have a higher or lower success rate depending on the specifics. But unless you have a couple of uninterrupted minutes (or you can convince them to read this article), the average person will still have no idea what you do on a day-to-day basis.

The point is that Quality Management is completely unknown to most people. Even within a company, most employees outside of Quality do not know what Quality does or just believe that management hired them to make things harder. 

If you’re ever hired to build a Quality department, the people hiring you will have some vague idea of what Quality means based on their past experiences, but trust me, you are on your own for all of the specifics. 

But, with all that said, you’ve found yourself here. Either you started at a company with a Quality department and you’re wondering how to make the switch, you’re in college and searching for what’s out there, or you are already in the industry and looking for positions to advance.

Welcome! Here at Hardcore QMS, we write about different subjects in the Quality Management field, specifically in the Medical Device industry. This article will break down many of the different careers in both the Quality Control and Quality Assurance sides of the industry to help you understand what career options are possible.

What industries have Quality Management Professionals?

For this article, I am focusing on Quality Management careers in manufacturing and related industries.

Many of these careers are in regulated fields, such as Aerospace, Automotive, Medical Devices, and Pharmaceuticals.  There are also Quality Management jobs in the general manufacturing and consumer goods industries, highlighted by the large number of ISO 9001 certificates.

What about software quality assurance?

This article will not cover any positions related to the nonregulated software industry. It is that industries’ fault that the career descriptions and job postings related to Quality are completely jumbled.  The software industry co-opted job names from a long-standing profession that dates back to the early 1900s, and I will not apologize for any disappointment or confusion.

What’s the difference between Quality Control and Quality Assurance?

Before I get started breaking down the different careers, let’s provide some background on the differences between Quality Control (QC) and Quality Assurance (QA).

QC is a set of activities performed once something is manufactured, including testing, inspecting, and analyzing defective materials. In my perspective, this ignores aspects of Quality Engineering, so I will broaden the definition to all hands-on activities related to manufacturing.

QA is considered a “proactive” approach to quality, building processes and systems that lead to a high-quality product or service.

Note: These terms will be used randomly in your career. You may be a “Quality Assurance Inspector” or a “Quality Control Auditor”. As I said, no one outside of Quality has any clue what Quality people do, so try to take everything I say related to specific terminology with a grain of salt.

Salary and “can be done remotely” Chart

Quality Control Careers

Quality Inspector

Quality Inspectors are the most hands-on professionals in the Quality field. They use a variety of measuring tools like calipers, height gages, micrometers, electronic instruments like coordinate measuring machines (CMMs), and others to measure and test products. Their job is to see if the parts and articles meet internal specifications and requirements and identify nonconforming materials.

Quality Inspection is the most “trade” like profession in the Quality space, specializing in one specific area that requires some level of physical labor. 

Quality Inspectors have to understand or learn basic math, geometric dimensioning and tolerances (GD&T), and measurement techniques.

Quality Inspection is often the entry-level position for people on the QC side of things, especially for people without a college degree. That being the case, many Quality Inspection jobs start at the lowest end of the Quality payscale, around $35,000-$60,000 a year.

Once you are in a Quality Inspector there are a few options available. You can transition to a higher level QC role like a Technician or Quality Engineer, or even branch into QA depending on your company (this is the route I took). Alternatively, you can take the experience gained in the manufacturing space to move into a different manufacturing area.

Outside of advancement, if you like your role in Quality Inspection, there is a very high upside for an exceptional Inspector. Please understand that these opportunities are rare, and you will have to specialize, obtain certifications in an industry involving welding or aerospace, and possibly relocate. 

But, at this high end, there are Quality Inspection positions available that pay over $100,000 a year without requiring a college degree. The other benefit at this level is that despite what people will say, you are less likely to have your position taken by AI than other Quality roles. If the materials could be inspected by computers, they probably would be already. Quality Inspection still exists because it is hard to automate the inspection of complex products produced at low volume.

Quality Technician

Quality Technicians share a lot of similarities with Quality Inspectors, as many companies treat it as a natural progression from the Quality Inspection role.

Quality Technicians still inspect and test products and write up nonconforming materials. All skills from Quality Inspection apply, however, there are added responsibilities and expectations. 

For example, a Quality Technician may begin training Quality Inspectors, investigating nonconformances, maintaining audit schedules, and collecting data related to product quality. If a Quality Inspector is the one running a CMM, a Quality Technician could be the one programming the CMM. 

Quality Technicians might also start performing activities related to QA, such as participating in internal audits, maintaining documents, and handling corrective actions.

Being a Quality Technician is another career that can be done without a college degree. From a review of job postings, the average requirements for a Quality Technician are a high school diploma and two to four years of experience (typically gained through Quality Inspection or time in a manufacturing environment). It could also be a job acquired through an associate’s degree or training in a manufacturing role like machining. 

Quality Engineer

Quality Engineering is incredibly broad, so it’s hard to pin down everything a Quality Engineer might do in this article. Quality Engineering can include manufacturing-focused positions, specialization in processes like validation, or QA-focused roles.

A manufacturing-focused Quality Engineer handles statistical analysis, performs complex root cause investigations on nonconforming materials, builds out inspection and control plans, validates processes, and plans process and product improvement efforts.

A QA-focused Quality Engineer may work on the Quality Management System (QMS), communication and investigations regarding customer complaints, audits, and improvement of non-manufacturing processes (speeding up product distribution).

There are also many different subgroups and specializations within Quality Engineering, especially at larger companies. Some Quality Engineers only work on equipment and process validation whenever a piece of equipment moves or a manufacturing process changes. Design Quality Engineers perform risk analysis and evaluate new products for manufacturing and quality impact.

Quality Engineers need to have a strong foundational knowledge of Quality principles and statistics. They should understand problem-solving techniques (8D, Ishikawa diagrams, Pareto charts), the Plan Do Check Act (PDCA) cycle, statistical control, and more. In my opinion, the heavy use of these tools makes Quality Engineering the most “true-to-Quality” career available. 

It’s also useful for Quality Engineers to understand Lean and Six Sigma principles. If you want to gain credentials in Six Sigma, you can learn more in my article about passing the Certified Six Sigma Green Belt exam. 

Quality Engineering is the point where we move from Quality “trades” into a professional career. That being the case, becoming a Quality Engineer typically requires a bachelor’s degree, specifically in engineering (mechanical, biomedical, manufacturing, etc). In fact, many mechanical and manufacturing engineers start their careers as Quality Engineers. 

However, there are some exceptions, and it is possible to advance to a Quality Engineering position with an associate’s degree or accumulated on-the-job Quality experience. (Note, this applies to US-based positions, as countries like Canada have protections in place dictating that you can only have “Engineer” in your title if you have an engineering degree).

Entry-level Quality Engineers sometimes earn less than their counterparts in other areas of engineering, however, the pay range for Quality Engineers is large, and there are lots of growth opportunities. On average, a Quality Engineer can expect to earn between $75,000 (at the very entry level) and $140,000 depending on education and experience. There are even positions for Senior Quality Engineers available that pay upwards of $175,000 a year.

Also, while many career certifications provide marginal utility at best, the Certified Quality Engineer (CQE) certificate offered by the American Society of Quality is beneficial and sought by employers. If you are new to Quality, this won’t help you get a job in Quality Engineering as it requires eight years of experience or four years of experience with a bachelor’s degree, but it is worth pursuing if you want to advance in Quality.

Supplier Quality Engineer

Supplier Quality Engineering is a subgroup of Quality Engineering that focuses on materials coming in the door. A Supplier Quality Engineer should have all of the same skills as Quality Engineers that were listed above, but their day-to-day responsibilities will focus on interactions with suppliers and supplied material.

For example, a Supplier Quality Engineer will manage incoming inspection efforts, monitor supplier metrics and nonconformances, and handle the administration of Supplier Related Corrective Actions (SCARs). They might also perform supplier audits or visit suppliers to help work through quality issues related to products.

Supplier Quality Engineering roles require more experience than entry-level Quality Engineer roles, and someone may have to work as an engineer or Quality Engineer for a few years before transitioning into Supplier Quality Engineering. The pay scale reflects this experience, and a Supplier Quality Engineer can expect to earn between $90,000 and $160,000 a year.

Quality Assurance Careers

Quality Assurance/Compliance/Systems Specialist

Now, we are venturing over into the QA side of things. For ease, I am lumping a bunch of different job titles into this one category, including:

• Quality Assurance Associate
• Quality Assurance Specialist
• Quality Compliance Specialist
• Quality Systems Specialist
• Quality Specialist

These jobs have very similar duties, and they are based on doing everything related to Quality Assurance and the QMS. Also, the industries with the highest number of these positions are the Medical Device and Pharmaceutical industries.

The specifics will vary greatly depending on the position and industry, but some of the activities included under these job titles include:

• Running the document management system.
• Administering the electronic Quality Management System (eQMS).
• Writing Standard Operating Procedures (SOPs), Work Instructions, and other Quality-related documents.
• Coordinating a company’s training program.
• Performing Internal and External audits.
• Leading Change Control Efforts.
• Tracking and trending quality data.
• Supporting customer, registrar/notified body, and regulatory audits.
• Root Cause investigations for internal and supplier nonconformities.
• Creating corrective action plans and ensuring CAPAs are carried out.
• Investigating customer complaints.
• Preparing Management Review material. 

At a larger company, the position may focus on only one or a handful of the listed activities. But at a medium or small company, you may be doing everything on that list!

To excel in the role, a QA Specialist (and related titles) needs to have a background in Quality principles, as well as an understanding of Quality Management Systems. If you are interested in learning more about Quality Management Systems, especially for Medical Devices, our website is a great place to start!

In addition to similar skills as Quality Engineers, these careers rely heavily on writing ability. The role involves a substantial amount of paperwork and the creation and editing of SOPs and other documents. 

Many times, especially at smaller companies, QA Specialists venture into regulatory work. We’ll discuss some specifics with Regulatory Specialists below, but learning or having an understanding of specific regulations, both as they apply to the QMS and other aspects of the regulatory landscape, can be very beneficial.

Becoming a QA Specialist typically requires a bachelor’s degree, however, the type of degree can be more varied. Engineering degrees are useful, but depending on the industry, a Biology, Chemistry, Quality Management, or even an unrelated degree can be sufficient. 

There are positions available that do not require a degree, however, they do require experience to make up for the degree. In my opinion, this is what makes these types of roles the hardest jobs to get in the Quality space. This may seem backward at first, but all of the other roles either don’t require a college degree at the entry level (Quality Inspector or Technician) or can be worked up to by building experience in different areas of Quality. 

But, if someone cannot break into the industry, they aren’t able to get started getting experience to move up through the other careers. 

If you are interested in this type of career and don’t have a degree, my advice is to either start on the QC side of things or try and get an entry-level position related to Document Control. There are some Document Control positions (administrator, coordinator, or specialist) that don’t require a degree and can provide some of the background and experience necessary to move into QA.

A large number of different titles have been included in this section, which leads to a large salary range. An entry-level person in QA can expect to earn between $50,000 and $70,0000, while a more experienced person or Senior Quality Systems Specialist can expect to earn $90,000-$130,000 a year.

Regulatory Specialist

I’m including Regulatory Specialists as a subset of the group I talked about above, however, there are plenty of disagreements about the relationships between Quality and Regulatory.

Regulatory Specialists will have in-depth and experienced knowledge about the specific regulatory requirements of their industry. Taking my industry (Medical Devices) as an example, Regulatory Specialists are tasked with preparing and submitting Medical Devices for clearance or approval to the FDA and other foreign regulatory bodies. They may help with the QMS as well, however, the submission process is typically what separates someone into a Regulatory position.

Becoming a Regulatory Specialist requires at least a bachelor’s degree and a healthy amount of experience in the industry. An advanced degree is also beneficial.

If you are working in a Medical Device or Pharmaceutical company and want to move into the regulatory space, you should try and learn as much as you can about the submittal process and how information is communicated with regulatory bodies.

Being specialized and having more experience, Regulatory Specialists can expect to earn between $100,000 and $165,000 a year. This is a great career path for someone who wants to move into consulting, as companies often rely on consultants for the preparation of submission documents.

Quality Auditor

Outside of being a Quality Inspector, a Quality Auditor may be the only position on this list where you can explain what you do to someone at a party. 

Put simply, Quality Auditors audit companies to Quality Management System and other standards. Some of these standards include ISO 9001, AS91000, ISO 13485, ISO 14001, and ISO 27001.  There are positions available for Auditors in a wide array of industries, including general manufacturing, Aerospace, Medical Devices, Pharmaceuticals, and more.

There are two different types of Quality Auditors I am going to discuss in this article. 

The first is a Quality Auditor who works for a company in one of the above industries. These positions share similarities with Supplier Quality Engineers, however, more time is dedicated to auditing suppliers. Alternatively, a Quality Auditor may be focused on performing Internal Audits at their company or visiting different sites and performing Internal Audits at a larger company.

The second is a Quality Auditor who works for an auditing and accreditation company. These types of Auditors are responsible for visiting different companies to see if they meet the relevant standards and can receive their ISO 9001, ISO 13485, or other certificates.

A Quality Auditor can expect to spend almost all their time (3 to 4 weeks a month) traveling to different sites. For this reason, many Quality Auditors are semi-retired professionals who have spent their life in QA. However, I believe this is also a great career for someone younger, with 2-4 years of experience out of college, who would like to travel for work and is not interested in sales.

Becoming a Quality Auditor typically requires a bachelor’s degree that’s relevant to the specific industry (for example, biomedical engineering or chemistry for Medical Devices) and 2-10 years of experience in the industry, or a substantial amount of experience as a QA professional who is performing audits are part of their duties. 

Quality Auditing also requires outside education and certification as a prerequisite for the position. This could start with the Certified Quality Auditor certification offered by ASQ, but audit training on the specific industry standard is also necessary.

As far as pay goes, a Quality Auditor can expect to earn between $85,000 and $150,000 a year based on experience.

Quality Management Positions

Quality Manager

Now that I’ve gone over some of the individual contributor careers in Quality, it’s time to break down the Quality Manager position. Just as each title can be used for many different types of jobs, a Quality Manager position adds up all of the variance and is as unique to the specific company as a job can be. 

A Quality Manager could manage a specific department for any of the roles we’ve listed. There are Quality Engineering Managers, QC Managers, QA Managers, Quality Auditor Managers, Regulatory Managers, and more. Or, a Quality Manager could lead both the QC and QA programs at a site or company.

In the most basic form, a Quality Manager directs different Quality professionals, interacts with management in different departments, and controls the budget for Quality programs and tools.

One thing that makes a Quality Manager unique from managers of other departments is that the Quality Manager may be officially responsible for the company’s Quality and QMS. This means that they will be in charge of any ISO certifications at the company and will be speaking with federal agencies that come to inspect the company.

In the Medical Device world, the official responsibility is mandated by the FDA as the “Management Representative” who is in charge of the company’s Management Review Meetings and will be held responsible if they allow unethical Quality practices to take place.

To become a Quality Manager, the main thing needed is experience, experience, experience. Typically, this means 5-10 years of experience in a Quality department (Quality Engineering or Quality Assurance) of the relevant industry. 

You also need supervisory experience. For first-time managers, the experience is often obtained through promotion in their company. However, if you are not able to be promoted at your company, look to gain experience by leading projects and quality improvement efforts. Once you have gained experience leading projects, you can seek out other companies that are hiring Quality Managers. 

The certifications mentioned in the above sections can also be useful in becoming a Quality Manager. This includes Quality Engineer, Quality Auditor, and Six Sigma certifications. 

The salary for a Quality Manager will vary depending on experience and industry. The average pay for a Quality Manager is about $100,000-$120,000, with entry-level managers earning as low as $70,000 and senior managers earning upwards of $160,000-$200,000 a year.

Director/VP of Quality

At the very top of the Quality hierarchy are the Director of Quality and Vice President of Quality positions. 

The existence of this type of role depends on the size and geographical distribution of the specific company. At certain organizations, the Quality Manager is the highest level of the Quality department, while at very large corporations, there may be multiple VPs of Quality.

Directors and VPs of Quality usually have multiple Quality Managers reporting to them, and oversight over multiple or all of the sites in an organization. They are removed from the day-to-day activities of Quality and are instead focused on guiding their reports, setting company-wide Quality processes and objectives, and leading large-scale Quality improvement efforts.

Like many Director and VP-level roles, a lot of the focus is on strategy. This can include a company’s regulatory strategy, strategic planning, and resource distribution. 

The Director/VP of Quality may spend a significant amount of time traveling to the different parts of an organization and be on call in case any of the facilities are inspected by regulatory bodies.

This level requires a substantial amount of education and experience. A bachelor’s degree is typically a necessity, while a master’s degree or even a PhD may be required depending on the industry. A person could also have a combination of a Bachelor of Science degree in Engineering and an MBA or other business degree.

As far as experience goes, companies look for someone with 10-20 years of experience in the industry and 5-10 years of experience as a Manager (for director-level roles) or Director (for VP-level roles).

Being the highest level careers in Quality, Director and VP of Quality roles pay a substantial amount. For Directors, this can be anywhere from $140,000 to $220,000, while for VPs, this can be $200,000 to over $300,000 at a large organization.

Wrapping Up

Quality Management can be a challenging and rewarding career, with many different paths available depending on your interests. Hopefully, you were able to learn something or gain some interest in a new role through this article.

If you would like to learn more about Quality and Quality Management Systems, be sure to explore the site and sign up for our newsletter. Also, if you are looking for any advice and want to reach out, you can do so at info@hardcoreqms.com.

The post Exploring Careers in Quality Management appeared first on Hardcore QMS.

Instead, I want to provide a framework for thinking about SOPs and other documents, and what the benefits are to different approaches. Each company will handle this question differently, depending on the specific tools and shortcomings of that company. However, it’s best to take a conscious approach to this question.

What do I mean by SOPs?

In the Quality world, people love to use different terms and acronyms for the same things. What I mean by SOP is: Standard Operating Procedure, Quality Procedure, Procedure, Top Level Procedure, etc. Wherever you document your training process is what I mean as an SOP. 

However, the same approach can be applied to Work Instructions (WI, work guides, work standards, you get the point). All of the documents ultimately fit into this same framework.

What do you need to document?

When a company decides to embark on the mission to meet a QMS standard (such as ISO 13485), they are presented with a list of processes that it must create and document. These processes will eventually be documented in SOPs. 

If the company wants to meet the standard, they don’t have a choice for which processes to implement. Everything in the standard must be documented in some way (outside of exclusions and non-applicable sections). 

That said, no one is telling you the number of SOPs you need to contain all of these processes. 

If you are an absolute lunatic, you could put every SOP for your company in one giant Quality Manual (believe it or not, you could pull this off and still have a shorter Quality Manual than some companies). 

On the other hand, if maintaining documents is your passion, you can create an SOP for every aspect of design control or each line of your document control process (review of documents, approval of documents, availability of documents).  I’m not stopping you (your boss probably will).

For a more realistic example, look at our recent articles on Supplier Management, Purchasing, and Verification of Purchased Products. An organization can combine all these processes into the same SOP or break them out into individual SOPs. Or, it can put Supplier Management and Purchasing in one SOP, and add Verification of Purchased Product in to an SOP on inspection. Or any other combination that makes sense! 

How do they choose?

What this comes down to is: do you want a larger number of SOPs that are more concise or fewer SOPs that are longer?

Greater Number of SOPs

I’m going to talk about having more SOPs that are concise first because that is my bias. But, I won’t judge you for taking a different approach; it’s your QMS and organization.

The benefits of this approach are:

• The more precise an SOP is, the easier it is to find the relevant information in the document.
• It’s easier to train people on a particular process. Maybe your Purchasing personnel need to train on both the Supplier Management process and Purchasing process, while Quality personnel only need to train on Supplier Management. If both of these processes are in one SOP, you can’t differentiate the training.
• Speaking of training, I believe this approach is better for having people actually read documents. If you hand them a 25-page procedure, it’s going to be a slog to get through. If you hand them five 5-page procedures, they can get through each one of them with a cup of coffee.
• Changes:
  • If the process is specific, you might need fewer people to review and approve changes to an SOP.
  • If you need to make a change to an SOP, you can do so without affecting broad procedures.

The issues with this approach:

• You have more documents to maintain and review.
• While I believe this is a better approach to training, it is certainly harder to maintain training documentation.
• It can be harder to find the particular document you need.
• In an audit scenario, you will need to flip between more documents.
• This approach will necessarily lead to a greater number of changes. If the change control process is complicated, this will be a challenge.
• If you require a lot of preliminary information in your procedures (responsibilities, definitions, etc.), you may end up with a bunch of documents that are one page of intro and half a page of the actual procedure.

Looking at these, it’s easy to imagine why this needs to be an organization-specific decision. If you don’t have a good system for handling documents, it will be difficult as there are more documents to maintain. If the company’s change control process is a slog, you might want to make fewer changes. 

This is why it’s best to understand how everything functions within a system at your organization.

Fewer SOPs

In the other corner, let’s look at having fewer SOPs that are longer. Overall, you can take the above pros and cons, and flip them for this approach. So, to keep things interesting I will try to add some new information on the specifics.

Some benefits of having fewer SOPs are:

• This approach could be better if your SOPs are focused on a very high-level view of the process with separate Work Instructions to build out the specifics.
• It can make your SOPs seem more important. Looking at the typical document pyramid, you have policies at the top, followed by SOPs. If you have only 10 SOPs, they may feel more significant than 30 SOPs. It’s all about perception, after all.
• All of the documents will be easier to maintain. You do not need to review as many procedures or have as many documents in training files, it will reduce your records and more.
• You can combine similar processes. If you want everything related to one subject in the same area, this is the way to go.

Additional risks and issues with this approach: 

• Making a change or editing the document could feel like a monumental task. Do you really want to change a 30-page SOP to fix a couple of minor issues? Or, you can add them up as drafts over time and leave yourself with a massive undertaking when it is time for change control.
• It could be harder to match each process required by ISO to the correct SOP.
• Training will be more difficult. People will have to read longer documents, or, if you are doing in-person training, employees will have to take in a lot of information that does not apply to their job.
• If the company decides to implement a completely new process, say, human factors, where are they going to put it? Will it be the only shorter SOP? Will it be added to the design control process, making it even longer?

Once again, you will have to do what is best for your organization. There is no set number or limit of required SOPs, and each approach should be based on the unique situation.

Put things where they make sense

Finally, when you are deciding on how many SOPs you need at your company, remember to put things where they make sense. Keep it simple.

While I prefer having more SOPs that are shorter, this doesn’t mean I break things up as much as possible. For example, when I created a document control procedure at my company, I included a section on records.

Could I break them up if I really wanted to? Sure, but it would not add the same benefits that I discussed. 

For example, the documents and records live in the same place within our QMS. If there were two SOPs, I would have to discuss the system twice. Also, everyone who is going to be trained on document control is going to be trained on records.  

However, if this is different with your organization or your document control procedure is becoming too lengthy, it’s totally fine to break them up.

Another example is with Corrective and Preventive Actions. Are these the same processes? Technically no, and they are in two different sections of ISO 13485. But do they use the same system? Are they similar enough to combine? This is why most organizations choose to have one CAPA SOP.

Put each process in the SOP that makes the most sense for your organization while keeping SOPs lean enough to get the benefits discussed above.

Didn’t you mention something about Work Instructions?

Yes, much of what we talked about for SOPs can also be applied to Work Instructions.

Say you are assembling a wheelchair.

If one person is assembling the wheelchair from assorted parts, it could make sense to have a single WI titled Assembling the XXXX Wheelchair WI.

However, imagine there’s a welding step involved. You can ask yourself: “Is the welding process performed only for this one model, or is it used on many different wheelchairs”?

If the company has a welding step for multiple unique models of wheelchairs, you could break out welding into its own WI, and reference it in the assembly WI. If the welding is only for one model but is performed by a separate individual or functional group, it could also make sense to break up the WI.

That said, it’s not a great idea to take this to the extreme. Maybe all of the wheelchairs involve a step to screw in the wheel. This doesn’t mean you want an entire WI dedicated to screwing in the wheels that is one step long and is referenced from all of your assembly WIs.

The goal is to find a balance between having someone jump between 20 different documents and having massive, cumbersome WIs that include long, repeated sections and involve five different functional groups.

Wrapping Up

Hopefully, this article was able to bring you some clarity on how you want to document SOPs and WI for your QMS. If you liked the article, be sure to check out the rest of the website which is focused on making better Quality Management Systems, and sign up for our newsletter below.

The post What’s the right number of SOPs for your QMS? appeared first on Hardcore QMS.

For the last hour, he’s been locked in on one form that was not filled out properly. You’ve been scrolling through other instances of the form and haven’t found similar issues and are cursing the fact that he chose that example. But he’s not letting up, and you can feel the minor finding creeping up behind you. You’ve already drafted the CAPA in your head, and all signs point to one action. Retraining.

Stop it.

Too often, quality professionals use retraining as a crutch to solve Corrective Actions. “It’s not the process. It’s not the form. Just one more training session will fix everything”. Maybe you even know the operator and can picture their face as you present the audit finding and inform them of the training session that will result from what you see as a willful lack of attention to quality.

Well, you better be sure that the process is indeed perfect. 

Retraining is an indication that a Quality department is acting as an adversary to the rest of the company (this is not the sole responsibility of Quality and may be preached by other departments). There is chaos amongst the ranks, and it is Quality’s job to reign it in, to force the employees and company into a state of order. 

But there’s another way. The quality departments in regulated industries such as pharmaceuticals, medical devices, and aerospace are often seen by management as a necessary evil put in place by the government. However, the history of quality control demonstrates that the origin of the profession was to make better products and processes.

An employee didn’t fill out a form correctly. While you can hold onto the view that this was human error, it is a great opportunity to truly examine the process. Employ the tools that are in the quality handbook. Look for creative solutions to the problem that will not only fix the error but also make the process better and coworkers more satisfied with their jobs.

Quality professionals sometimes hold onto a view that a process is not the problem even if it was an inherited process, put in place years ago by a Manager they never even knew.

I’ve seen a lot of processes, and I’ve filled out a lot of forms, and I am sure that almost all of them could be improved. Quality should be seamless in the way it is integrated into day-to-day operations. When operators are constantly struggling or fighting the way processes are implemented, it’s a clear sign that something needs to give.

A lot of the time, the person performing a Corrective Action will default to listing retraining as the action. Someone messed up and didn’t fill out a form correctly. Everyone will be trained on the process and taught how to fill out the form correctly. It sounds nice and simple, but it’s the result of someone stopping at the first or second Why and not getting to the root cause. 

It also opens up another can of worms for a Quality department. If you have three Corrective Actions, and the actions taken for all of them were retraining, how on earth can you say that your training program is effective?

A form being filled out incorrectly by a production employee, leading to an entire overhaul of a company’s training program, would be a more effective and honest way to solve the issue than simply retraining. And if you take this approach, good for you! This is a much better approximation of the root cause!

I will also add here that almost all CAPAs will include training or retraining as part of the actions. However people should be trained on the new, improved process, not the process that was already found to have holes.

Let me tell you, dear reader, I am not without sin regarding this issue. Recently, I was in this exact situation at my company, finding that a certain section of a form was not being completed correctly. And while it was a repeated issue, all of the mistakes were made by one person. Is this not a perfect indication that they just need to be retrained on the form?

However, I decided not to implement actions right away and took the weekend to think through the issue. And it finally dawned on me. Why the heck am I having people fill out this section of the form to begin with?

All the information is already captured elsewhere in a more appropriate place. Filling out that section of the form required an understanding of multiple unrelated processes and caused my coworkers to spend time writing the same thing over and over. My other coworkers were filling out the form correctly, but it was not adding value in any demonstrable way. 

So I removed that section! Not only will the issue be impossible to repeat in the future, but it will also ease the burden of every single employee who has to fill out that form. This makes it more likely that the rest of the form is filled out correctly and that the process is completed without hitches. It also means that people can spend their time focusing on the quality of the rest of their work.

I’ll admit, this is an easy example. There will be lots of times when a form or process cannot be changed to this extent (although less than you probably think). But it’s just one example of how a mistake can lead to a better process. I believe that when you focus on what you can do to make your coworkers’ work more efficient, you will find that this leads to better and more sustainable quality.

The next time you are presented with a problem or a finding, and your first response is to retrain people on a process, don’t let yourself jump to conclusions. Take a moment, or a week, and really examine the process. You might find that even though it’s an isolated incident, there is still room to make it better.

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“When a measure becomes a target, it ceases to be a good measure.”

On its own, it’s a beneficial concept for Quality Management. For example, if you record the time it takes good, well-trained inspectors to measure a part, it won’t provide any benefits to broadcast the result to the inspectors. Since there is now a defined time that constitutes a good inspection, all inspectors can focus on hitting that time, instead of concerning themselves with the quality of the parts. The metric, inspection time, is no longer accurate.

But today, I’m talking about “Good Manufacturing Practices” and Quality Management Systems and introducing my twist:

When a Good Manufacturing Practice becomes a requirement, it ceases being a useful indicator of a Good Manufacturing Practice.

If you look at well-run manufacturing companies, you’ll discover that they have documented processes. If you survey enough of these companies, you’ll find that many of these processes are similar. 

From there, you can create a guideline or “standard” that includes all these processes. Then, you can build an audit plan for that standard that gives you criteria for ensuring the company has all the practices in place. If a company shows they have the required documented processes, you can issue them a certificate that allows them to display their competency to customers and regulators.

However, people who have spent a decent amount of time in Quality know of companies that are certified to different QMS standards, and yet you can’t shake the feeling that they have no idea what they’re doing. It might not be something that can be traced in an audit finding. But the Quality is just…off. The processes are there, but they’re bad or inefficient.

On the flip side, have you ever spent time with a luxury watch in person? I mean, really spent time and looked at every machining technique, every detail, every texture?

A Cartier watch is a beautiful work of art. It’s amazing. 

And yet, and this may surprise you, Cartier is not ISO 9001 certified. So, how can they be producing such a high-quality product, over and over and over again?

I’m sure Cartier has processes in place for manufacturing their watches. If you look at their Quality and Performance page, they list some of the different tests their watches endure to get them up to Cartier standards. However, these processes weren’t put in place to match GMP criteria or receive a QMS certification.

How is Cartier able to do this? 

How are there companies that are legally obligated to follow Good Manufacturing Practices and are bad at manufacturing, while unregulated, non-certified companies produce high-quality products?

Cartier’s quality is built around its internal goals and meeting customer expectations instead of conforming to a standard.

The luxury watch market is extremely competitive. No one needs a luxury watch. Timekeeping has been solved, and a mechanical watch is a poor solution.  So, if you are a luxury watchmaker, you need to listen to your customers and create the best quality product you can put in a display case. 

Every single time.

Looking at other excellent manufacturing companies, you’ll see that the processes they put in place have a purpose. They understand the “why” behind the processes.

A company can put in place any process it wants to conform to GMPs, but unless it understands and cares about the “why” of that process, it won’t lead to better quality. 

Take training as an example. If a company is not required to meet any GMPs and is not ISO certified but still has an effective documented training system, you would think highly of that company. You might trust that they are making something of good quality.

However, in certain regulated industries, organizations are required to have a documented training system. Many companies choose to have a superficial training program that technically meets requirements but does not create the intended value.

Therefore, an organization in this industry having a training program in place does not tell you anything about the quality of the organization, by the very fact that a training program is required.

This is one of my pet peeves when I see something like “ISO 13485 certification guarantees that an organization is producing high-quality medical devices.” No, it doesn’t. ISO 13485 certification guarantees (or at least hopefully guarantees) that a company is meeting the requirements of ISO 13485. This and good quality are two separate things.

Unfortunately, this cannot be solved by better regulations or standards. Anything regulatory agencies or certification bodies do, anything they define as a Good Manufacturing Practice will still fall victim to Goodhart’s Law. Once a practice is established as a requirement or goal, it allows a company to put a superficial process in place to meet that requirement.  

The funny thing is, they know it themselves.

If you read through the MDSAP audit approach section on supplier management, it says (and I’m embellishing here): “Yeah, you can check if a supplier has a third-party certification, but for god’s sake don’t rely on that to think the supplier is good quality.”

So what can you do about it?

If you need to evaluate a company from the outside, there are talented, experienced auditors and professionals who can tell the difference between good quality and meeting requirements (smell the BS). However, these people need to be empowered. If the organization that sent the auditor is itself just trying to check a box, it will ignore the auditor’s advice. “Do they meet the standard? Good enough.”

It becomes harder when a company internally faces this reckoning.

Ultimately it is the responsibility of top management and Quality Professionals to understand the “why” behind the processes they put in place, and deeply care about the quality of their products. 

To not only know how to comply with an ISO standard, but why the processes are beneficial to the company and can lead to higher quality. Not just teach people how to do tasks, but also the purpose of those tasks. 

Anyone can find out the requirements of “Good Manufacturing Practices” and standards, but just following them does not lead to good manufacturing. 

There are no Good Manufacturing Practices that will show you the way. 

The only way a company can achieve good quality is through a true, internal, continual commitment to creating the best possible processes, products, and services it possibly can.

Every single time.

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As many of you know, the American Society for Quality (ASQ) is the largest and most respected company in the quality space. They produce a magazine, run a website with tons of useful information, and host dozens of quality conferences and seminars to name a few things.

While I have plenty of experience related to Six Sigma, I wanted to get the certification from ASQ, because it is the most recognizable to companies. The CSSGB exam is also a great stepping stone to becoming a Certified Quality Engineer, so I figured I would get it out of the way before taking the CQE exam.

Basics of Applying for an ASQ Certification

I am already a Certified Quality Inspector and was familiar with the process of gaining an ASQ certificate before applying.

To start, you need to apply through the ASQ website. Each exam has a certain amount of years of experience necessary to apply for the exam (note: education may substitute for some of the years of experience on certain exams). The CSSGB exam requires three years of experience, which is easy to achieve, however, there are no educational waivers for this particular exam.

The application is fairly simple and includes basic information and details about your experience. At the time you apply, you will need to pay for the application fee and exam fee. As of 2023, the application fee was $130. This amount is included in the price of the exam, however, it is non-refundable if your application is denied or if you later cancel the exam.

The total cost of the exam is $469 for non-members and $369 for members. If you are not already an ASQ member, you should consider becoming a member before getting the study materials and applying for the exam.

The membership fee is $185 (this has been raised since I began my membership), but can almost make up for the costs based on the exam fee discount and the discounted study materials. It is more beneficial if you plan on taking multiple exams in a year, or if your company is going to cover the costs of membership.

Study Material for the ASQ CSSGB Exam

Once I applied and was accepted to take the exam, I purchased all of the study material I would need for the CSSGB test. While some people may prefer to study the material before applying for the exam, I like to have a hard date in place to increase motivation.

One thing to note is that almost all ASQ exams are open-book tests. For this reason, the study material that you get plays a significant role in passing the test.

To start, I got the ASQ CSSGB Handbook. This is the number one thing you need if you are going to take the CSSGB exam. It is the foundation for many of the questions in the test and will provide the answer to 90% of questions when properly used. It’s likely that if you already have a quality background, you could get the handbook by itself and still pass the exam.

Before the test, I also put a large number of book tabs marking specific areas of the Handbook (post-it notes are only allowed as book tabs). This helped me easily reference sections during the exam, without having to look at the table of contents or glossary.

The other study material I got from ASQ was the ASQ CSSGB Study Guide. This provides several hundred questions that are directly related to the study material, and give you a good feel for the exam. While there are parts of the Study Guide I do not like (some of the answers are incorrect, which drove me crazy), I do enjoy quizzing myself before the test, so I felt it was worth the cost. (Note that you cannot take the Study Guide into the exam).

Outside of the ASQ material, I also got several items from the Quality Council of Indiana (QCI). QCI makes some great study guides to help with a variety of ASQ exams. While I would not say it is the best for studying the material, the way it is laid out is very useful for actually taking the exam.

From QCI, I got their main piece of study material for the CSSGB exam, the CSSGB Primer. I do not believe the Primer is sufficient on its own, but it is a great compliment to the ASQ Handbook. The Primer also includes a large number of questions for each section of the exam.

The questions provided in the Primer are significantly more difficult than the questions in the CSSGB exam, so if you are doing okay on those questions, you can be confident you will pass the exam. To go along with the questions I also got the Solutions Key, which provides detailed answers for all of the practice questions. (Again, you cannot take the Solutions Key or questions from the Primer into the exam).

The final piece of study material I used was an online Six Sigma course offered by Coursera. This is something that is not necessary but is nice for someone who likes to learn via video or from multiple different sources.

Studying for the ASQ CSSGB Exam

The amount of time you need to study for the exam will vary greatly depending on your confidence in taking tests and your exposure to Six Sigma content.

If you have already taken some Six Sigma courses and are familiar with the material, you could likely pass the test by just skimming the CSSGB Handbook.

However, if the material is very new to you, you should consider spending more time studying for the test, or possibly taking an ASQ study course for the exam (especially if your company will pay for the course).

Personally, I spent about 1-3 hours a day, 4-5 days a week, over 8 weeks studying for the exam. My method was to read a section of the Handbook, then read the same section in the Primer, and then watch the videos for the same section on the Coursera course. I would then go over all of the practice questions for that section, and restudy any questions that I missed.

Before I actually took the exam, I also went through all of the practice questions in a row multiple times to simulate taking the exam. I would recommend answering the practice questions open-book since your ability to find the answers to questions is more useful than straight memorization.

This was likely overkill based on the difficulty level of the exam, however, I was able to move through the exam with confidence and could answer about 75% of the questions without referencing any study material. So, feel free to base your study time on your knowledge

Taking the ASQ CSSGB Exam

There are two options for taking the ASQ CSSGB exam; in-person, and remotely proctored. I actually attempted to take the exam remotely. However, I had some major issues that I will discuss in a later post, so instead, I ended up taking the test in person.

The process of taking the in-person ASQ CSSGB exam is fairly simple. You need to show up at the facility about 30 minutes before the exam starts. You then need to empty your pockets and put anything you brought into a locker that is provided. I would recommend taking some water and possibly food with you if you think it will take you a while to complete the exam since these can be accessed during your break.

Then, meet up with the proctors at the facility who will give you a rundown of the test. I had to show my arms and ankles and then was checked with a metal detector. The proctors will then look through your study material to make sure there are no loose pages or other issues (I find all of this pretty ridiculous for an open-book test. What will I have written on my ankles that would be more useful than the study material?).

After the check, you are brought into the room where you will be taking the test. You are provided headphones by the facility to keep out some of the noise of the other test takers. The proctor will set you up with the computer you will be using.

After getting through a small amount of setup, you are able to start taking the CSSGB exam. There are 110 questions on the CSSGB exam, of which 100 are graded. From my experience, the questions are relatively simple, and about 90% of the questions can be answered directly from the CSSGB Handbook.

During the exam, you can also flag questions causing you issues. There were ten or so questions that caused me difficulty during the test, so I just flagged those and answered them at the end.

You are also allowed three ten-minute breaks during the exam, during which you can get any water or use the bathroom. You will have to do the check-in process again once you are done with the break, so I would recommend not pushing the time limit too much.

All-in-all, the exam took me about 90 minutes (although, I have historically been a fast test taker). I took one break for a couple of minutes to grab a drink of water but otherwise wanted to stay focused on the test.

Once you are done with the exam, the results will instantly be displayed on the screen. This is awesome since you will not have to nervously wait to find out if you passed. You will also receive an email a couple of minutes after the exam is completed that states your results.

Lessons Learned

Now that we went over my experience with studying for and passing the exam, let’s summarize the key points and lessons to help you pass the exam on the first try.

• Sign up for the exam right away. While this won’t necessarily help you with passing the exam, a lot of people are motivated once they have an actual deadline in place. Otherwise, it’s too easy to procrastinate studying and preparing.
• Get the ASQ CSSGB Handbook. This is the most essential element of having an easy test-taking experience. It is the basis of what you need to know to study for the exam and provides answers to the majority of the questions on the exam.
• Add lots of book tabs to the Handbook and any other reference materials you will bring. Since the exam is open book, it makes it much easier if you can quickly find specific pieces of information.
• Take the practice tests open-book. You can take the practice tests without any study material as well, but it is more relevant practice for the test if you look for the answer in the Handbook while answering a question from the study guide. That way you get used to searching through the Handbook (or whatever material you choose) to find the answers to questions/
• Your need to study for the exam will vary. As I mentioned, if you are already familiar with the material, you can probably just read through the Handbook and use it during the test. If Six Sigma is completely new to you, you should study a lot longer to prepare.
• Make sure everything is ready to go on exam day. This is general test-taking advice, but you should prepare yourself so that you don’t have to stress about any of the technical details on exam day. Read up on everything required a couple of days beforehand, have all of your reference material ready to go, try to get good sleep, and show up to the exam facility as early as makes you comfortable.
• The CSSGB is a great jumping-off point for other exams. While some of the material is specific to Six Sigma, a lot of the material consists of general quality ideas and tools that will help you for a number of different ASQ exams.

Wrapping Up

That was my experience with studying and taking the ASQ Certified Six Sigma Green Belt exam. Hopefully, after reading this, you will feel more confident about what you need to do to pass the exam on the first try. If you have any questions about the test or Six Sigma in general, please leave them in the comments section below and I will answer them to the best of my ability.

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The post Passing the ASQ CSSGB Exam: Tips and Tricks appeared first on Hardcore QMS.