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What is a Quality Manual & Quality Management System in Manufacturing?

At some point, someone is going to ask about your company’s Quality Manual and Management System.  You may get a questionnaire from a distributor that asks for a copy of your manual or when you hire your Director of Quality they will ask if you have one.   You can take steps now to start developing your system. By thinking through what the right Quality Management System is, rather than generating something in a rush, your organization can build something that is useful and generates value.

Before we talk about quality management system, we should talk about what “quality” is.  Quality broadly refers to one of four aspects of your company and product:

  • Quality of design out of the box.  How well does your product design meet needs and delight your customer?  This can include ID, features, function, cost, ease of use.
  • Quality of the design over time. How durable is the product?  Does the product fail?  What are your warranty issues?
  • Quality of manufacturing.  Do your suppliers and factories build products that are defect free and have minimal variation?
  • Quality of service/interaction.  Are you able to have transactions with your customers that are problem free?  Do units get delivered when they should?  Do you respond to problems quickly?

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The first type of quality can’t be formalized; it is part innovation and part diligence.  However, the other three require an organization to be more formal and disciplined about how quality is defined, verified and how the processes are executed.

What are the parts of a Quality Management system?

Googling the term “quality management” will turn up an alphabet soup of acronyms and terms.  They aren’t always used consistently across sites and it can be quite confusing. Here are the most common definitions used by industry:

  • Quality Policy is the overall statement of what is important about quality and what the quality goals of a company are. It can also be called the quality vision or quality mission statement.
  • The Quality Management System is the overarching term that encompasses all of the processes, procedures, meetings, data, documents used to create and ensure quality.  Whether you document it or not or if it is organized or ad hoc, you have a quality management system now.
  • The Quality Manual is the actual document where the policies and procedures are defined.  Ideally, the quality manual should document the entire quality management system but early in a company’s life, only the critical few will need to be included.
  • ISO certification is the process of having an external auditor review all of your quality processes and documentation and certifying that they are up to the written down ISO standards.
  • Quality organization defines who is responsible for what aspects of the processes.

When you google these terms, there are some very scary pages about get certified and sample quality manuals that are full of jargon and verbiage. Your likely reaction is not going be “wow, this sounds really useful and will help me.” Likely your first reaction is “this is not the way we run things,”  “we can’t be this rigid in our approach we need to be flexible,” and “we aren’t big enough to need this formal process.”   

Creating the framework for a formal quality management system is pretty straightforward.  Once the framework is created, it becomes a living document that will grow and change with your company’s growth.

Quality manual

“What is a quality manual?” is a question I get a lot from small organizations.  They know they need one (usually because a customer asks for it) but are very scared off by the IS9000 requirements huge manual and the sheer volume of work to get a very large brick of paper.  Often the work to develop these policies and procedures end up as a very expensive doorstop.

The ISO sets a very formalized organizational structure, which you can choose to follow if it works; otherwise, you can create a much simpler version which just contains the processes critical to your business. At minimum, a quality manual should contain the following:

  • Revision history and signatures.  The quality manual should be a “controlled” document.  This means that the current version document should be reviewed and approved.  Any changes to the document should be documented each time and the new version released.
  • Quality policy.  Defines the overall goals of the organization relating to quality.
  • Organization. Provide the organizational chart along with a description of who is responsible for what aspects of quality and the quality management system.  
  • Quality processes.  Define the common procedures and policies that need to be done consistently to ensure quality.  The process should be documented and include
    • A list of all of the steps in the process
    • Who is responsible for doing the work and approving it.
    • Description of how the process completion is confirmed complete.
    • What documents result from the process and where are they kept.

Quality Policy:

The quality policy is the first element of the quality management system.  It is a kind of mission statement for how your organization approaches quality.  You can find lots of examples on the internet.  While this can seem like make-work, it is important to have the discussion about what aim you have for the quality of your product.  At some point a tradeoff between the various aspects of quality may need to be done: for example, between a new innovative feature and the potential durability issues.  The corporate quality policy should provide guidance on how those tradeoffs should be made.

Quality Processes:

Why do you need to define your business and processes? When companies are small and there are a limited number of people, you can solve problems and keep track of issues by shouting across the desk.  Problems crop up and you just solve them quickly.  If customers complain, you have a phone call, brainstorm and get a solution in place.  Everyone is empowered to make decisions.  This flexibility and speed is critical in the early stages of a product but can become a liability later on.  As companies grow, you will have more people to keep in the loop, more issues to keep track of, and you will need a standard drum-beat process for defining and communicating the forecast.

It will be necessary to define some key processes and get agreement on how they should be done.  This ensures that the process is done the same way each time and that new people in the teams learn the right way first.  Here are a few processes that are beneficial to standardize and document.

  • Order taking. How do orders get translated into shipped products.  If you are satisfying orders to distributors (think Best Buy), there should be a process to ensure there is sufficient material to satisfy the order.
  • Complaints and returns. How does your company accept a complaint or product return?  Who is responsible for providing replacement, where does the data get collected and how does the return get managed in the financial system.  You will have to reconcile the warranty accrual with the cost of the returns. You will want a process to record the return data for both quality improvements and financial tracking.
  • Inspection and testing.  The requirements for shipment audits and any additional testing should be documented and the process followed exactly.
  • Design changes and document control (how to release a change to the factory).  Once the design is stabilized, you will need a process for how to release a design change. This can include verification testing, planning for cutting in new inventory, spares.  In addition, you will need to put in place drawing release processes to ensure that the right drawing version is available to all.
  • Software release process.  The same with software release.  There should be a process for how new software is validated, released, and updates forced in the factory and or remotely servicing devices.

ISO certification

ISO certification is a very long and time-consuming process.   It can take many person years to develop the documentation of all of the processes, ensure it is in the right format and then the process of auditing.  There are many consulting organizations that you can pay to help you but the process is expensive and distracting.  For small companies without their own internal manufacturing, the value of getting ISO certified usually doesn’t justify the expense and resources (which could be used to develop the next product). You should select a  contract manufacturer who has an ISO certification.  That along with your quality manual should be enough to satisfy any requirements.

Next steps:

What are the first steps in getting your Quality Management System defined.

  1. Draft several options for the Quality Policy statement including what terms might be used.   Use other company’s’ Quality Policies as a starting point to find one that resonates.   Review with the key stakeholders in a group setting.  Set clear expectations for this meeting so it doesn’t drag on.
  2. Create a list of what are the top three to five processes that should be documented.  These should be those which are communication intensive, where mistakes have been made and where everyone agrees “this should be easier.”
  3. Draft the processes including the information described above.
  4. Define who is responsible for what aspects of the quality management system.  You can answer questions like:
    1. Who owns the customer return process?
    2. Who approves changes to the design to improve quality?
    3.  Who reviews the quality data with the factory?
    4. Who owns the manual and keeps it up to dates?
  5. Draft the document and review with the people who have been signed up as responsible.
  6. Format and release!

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