Total Quality Management System in Manufacturing
For those who are new to the site or don’t personally know me, I currently work as a global continuous improvement and quality engineer for the marketplace leader of cables. This is something new to me, as I have always been at the local level previous to this role, but now from a global perspective, I’ve come to realize the importance of developing and maintaining an outstanding total quality management system, TQMS, in a manufacturing company.
In this post I want to cover the entire scope of a quality management system. This will probably end up being a very large post, so as a reader I encourage you to skim to interesting sections to you and find useful information before clicking away. Let’s get started!
Total Quality Management System Goals in Manufacturing
Manufacturing environments often struggle in the concept of quality, especially if you’re in an industry that prioritizes production volumes over quality. This is something characteristic of smaller industries which are making products that have the ability to fail. That is to say, if you make something that can fail with minimal consequences, quality is often not considered a priority.
For me, the cable industry presents this exact situation. Since products can fail with sometimes little consequence, quality takes a seat on the back burner. As industries begin to squeeze every last bit of margin due to the revolution of manufacturing with big data, these failures are becoming less and less tolerated by the market. As such, quality is slowly becoming more and more evident in these manufacturing environments.
TQMS are put into place with these goals:
- Create a system where ownership of projects exists
- Ensure quality systems & processes are effectively deployed and executed
- Monitor progress and remove road blocks for the TQMS
- Provide people with support, processes, and skills to execute a quality system
- Recognize and celebrate success throughout the company
You may notice in these goals that nothing about the physical product exists. That’s because much like safety in the workplace, quality comes inherently whenever you do everything else right.
TQMS Benefits in Manufacturing
But why should we do it? I get this question on a deep level. “We’re a cable industry – quality is not that important. If it fails we replace and move on.” There’s a lot of reasons why quality should be the driver of a business.
What’s the true cost of a quality defect? Sure, as a business we can calculate the cost of the raw material or the product, make a fancy spreadsheet, and pass this on to the management team. But how much damage have we truly done in the eyes of the consumer?
As the world transitions more and more online, companies and individuals alike will no longer be able to hold secrets like they once were able to do. Everything is public domain. As soon as one individual is not happy with their product, they can broadcast this to the world with facebook, twitter, youtube, etc.
While some quality defects are especially hurtful for a company financially, others can hurt the brand image, destroy customer relationships, create internal problems, or ultimately shut down the business.
The critical benefits of a successful TQMS:
- Engage associates in perform
- Drive continuous improvement actions with a quality baseline
- Base decisions on facts rather than instinctual opinions
- Standardize work in all areas
- Eliminate waste and reduce variation
- Ensure employees have necessary skills
- improve organizational effectiveness
Notice again – nothing about the product. Although minimizing nonconformities is the obvious benefit, that happens whenever everything else begins to take shape.
Total Quality Management System from Scratch
Minimum Set of Standards for TQMS
How do we start building a TQMS for manufacturing? The age old argument of quality vs product comes into play here. Poor quality leads to no customers, but if you start with no customers in the first place, quality doesn’t exist. But arguing aside, TQMS have to be built with a customer centricity.
- The voice of the customer
Every good TQMS will start by being proactive in establishing an effective system of gathering customer requirements. Once you capture these requirements, you should have place processes to document these requirements, communicating them to the manufacturing team, and a quality system to ensure these requirements are adhered to.
2. Flawless Launch
A flawless launch is a tough thing to achieve whenever the projects increase in size. Anyone can manufacture something right the first time if it’s a simple one component product. But what about when the scale changes? What are the steps?
How feasible is it to manufacture the product to the customer requirements? Sometimes optimism can get us in trouble and we need to have in place a system of evaluating projects unbiasedly.
Concept is always an important topic. As a manufacturing company we should look to address a problem, not create a product. Customers sometimes think that they know exactly what they want, right down to the specifications – but remember, they are on the outside of the cable industry most of the time. We need a system to evaluate conceptually if the proposed solution fully address the concerns of the customer, not just if we can make what they’re asking for.
C. Business Evaluation
Of course we can make it but should we? It doesn’t make sense to embark on an endeavour that doesn’t have a return for the company. We should create a system that evaluates the customer requirements while also taking the quality risk into account. If there’s high quality concerns, we should perform calculations weighing the risks and rewards to a new launch.
D. Product & Process Design (& Supplier Risk Assessments)
Do we have the machinery to do this new request? Are we capable of designing the new product in house or will we have to consult an external agency? We should consider these risks along with the supply chain in determining if a flawless launch is possible.
E. Product & Process Validation
Once we decide that we should proceed in launching a new product, we need to count our steps and validate them. We’ll need to validate the process capability, the workers of that process’s abilities, and the training system we have in place for this process.
A new product should never be launched if proper work instructions and training is not launched alongside it.
F. Launch and Control
No launch is truly flawless, but you should consider the shortcomings and assess the risks of the process before. Be prepared for the issues that may arise in the process before you encounter them. An hour of time preparing usually saves ten hours of time on the backend.
I believe every company struggles with this. Once the job concludes we say “Good job!” and move on to the next project. but, I strongly encourage you to wrap up the previous project before moving on to the next one. Document the experiences and lessons learned while they are fresh on your mind.
The leadership is the most critical component of developing one of these systems from scratch.
Leadership can come in many forms – not necessarily management. One of the big ideas of developing a TQMS is empowering many people to “own” their work and take pride in the outcomes. Motivate everyone to be involved and the leaders will step forward. Celebrate their victories.
TQMS – Suppler Management
The pain of a bad supplier is enough to drive you crazy. Deliveries not on time, bad raw materials, and poor customer service can really derail a otherwise smoothly running organization.
A good TQMS should consider the effects of the suppliers and mitigate risks among them. Let’s look at how to do it.
- Supplier Selection and Approval
The selection of suppliers should be a process that has methodology – not just “we’ve bought from them for forever.”
Develop an auditing system for your current suppliers along with a process to validate new suppliers. You should be recording the on time deliveries of your suppliers, the quality of their raw materials they are supplying to you, and also their customer service to your purchasing team.
- APQP & PPAP Process
APQP includes a lot of the other topics of this post. In short, it says that you should consider 23 topics before reaching the production phase of a process:
APQP focuses on:
- Up-front quality planning
- Determining if customers are satisfied by evaluating the output and supporting continual improvement
APQP consists of five phases:
- Plan and Define Program
- Product Design and Development Verification
- Process Design and Development Verification
- Product and Process Validation and Production Feedback
- Launch, Assessment & Corrective Action
The APQP process has seven major elements:
- Understanding the needs of the customer
- Proactive feedback and corrective action
- Designing within the process capabilities
- Analyzing and mitigating failure modes
- Verification and validation
- Design reviews
- Control special/critical characteristics.
Meanwhile, PPAP focuses on the supply chain of suppliers from a more documentation of the process. Both have overlaps though. Here’s the import concepts of PPAP:
- Design record with all specification
- Authorized engineering change number (ECN)
- Customer Engineering Approval
- Process is defined
- Process is documented
- Linkages of process are established
- Process is monitored, analyzed, and improved based on data
- Records are created, maintained, and retained
- Validation Test Report
- Control Plan
- PFD (Process Flow Diagram)
- Lab Test Report
- DFMEA (Design failure mode effect analysis)
- PFMEA (Process failure mode effect analysis)
- MSA Study
- Supplier Management of Change (MOC)
Change is scary to most employees. We don’t like it! We’ve done processes a certain way for a long time – why try for better efficiencies when what we do is working. Especially with those hard nosed suppliers?
With a TQMS we need to consider the management of change processes set in place at a local level. How difficult is it to bring in a new supplier of a material? How often do we seek out new suppliers? Sometimes MOC can lead to great benefits.
We need to establish a process of Documenting the change, reviewing the change, and then approved or declining the change with the proper leadership team.
- Communicate nonconformities
Suppliers can sometimes be difficult to communicate with. This is why we need to create a standardized way of reporting nonconforming raw material back to them.
We should set clear expectations of the raw materials we’re taking in and then if anything isn’t up to par, this should be quickly communicated back with corrective action to follow.
- Supplier Performance Monitoring
A couple things go into this point.First we should be checking the certifications of the raw materials coming into our plant. Are they passing the requirements of the product? We need a way of storing these documents (hopefully digitally) with the ability to pull them later.
We also need to create a system of monitoring long term supplier trends. Without documenting the data it is often easy to get frustrated with suppliers with two immediate failures back to back – but has this supplier done better historically? Our system should be able to perform these calculations and give us this data readily.
Quality Risk Evaluation Process
Now, we have the requirements and the supply chain taken care of. Let’s talk about how we can evaluate risks from a quality point of view.
We’ll need to create a systematic way of risk identification.
What should trigger a risk identification process?
- New business / new product
- New supply chain / supplier
- high profile or reoccurring issues
- Major change of events
- High fluctuations in workforce or production
- product or manufacturing process transfers
There’s other events which should trigger a risk evaluation process too – but those above are focusing on the quality side of things. Obviously if there is a safety event, you should be triggering an internal risk evaluation on the process as well.
But once a risk occurs, how should we evaluate this risk?
- Design FMEA Activities
FMEA, Failure Mode and Effects Analysis, is an inductive reasoning methodology which is used for finding single point failures in a system.
Since I’ve worked as a reliability engineer before, FMEA first occurred to me as concept outside the scope of quality. But there’s variations of FMEA that cater it towards designs and functions.
In one sentence, FMEA is looking at every component of a system, identifying the risks of that component, and should that component fail, what would happen.
- Process Flow Activities
Process Flow isn’t something that we often overlook. We should address how the process behaves within the plant, not just on paper. Are there risks associated with the movement of material? The ordering of the equipment? We should address these in our risk analysis
- Process FMEA activities
The same way we did FMEA for the components of the product, we should do FMEA for the process components as well. Where are the criticalities in the process? Do we have the process capability in the long term?
- Process Control Plan Activities
Statistically, are there risks involved in the variations of your process? How tightly can you manage process parameters to meet the requirements of the product? What risks are associated here?
- Work instruction activities
Are documents up to date? Have we trained operators to the desired level yet? People often create most of the issues with a well performing manufacturing line. We can not expect to carry out successful execution without training the operators running the process.
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