Documentation is key.

Documentation must be designed and structured in order to be useful to everyone involved in the manufacturing process. Documentation of Quality Management Systems must be available and understood by all personnel that have an influence over product quality. This requires a top-down approach to how a manufacturer organizes their knowledge of the process, starting with big picture processes, and further defining how the Quality Management System applies to total control manufacturing.

How and Where to apply Quality Management Systems.

When implementing a Quality Management System, a manufacturer should consider how and where to apply the systems so they do not over-engineer solutions where problems will not exist. This, again, ties back to Quality Risk Management and understanding the results and quality specifications required for each stage of manufacturing.

Quality Risk Management should be considered from the beginning of Quality Management System development. Implementation of Quality Management Systems cost companies money, and should be selectively used where risks exist, rather than a company wide implementation. While all companies could benefit from full applications of QMS, there are many activities that would have no benefit from such systems.

Quality Assurance and Quality Control.

QMS is not a self operating stand alone system – it requires Quality Assurance and Quality Control Departments. These departments, which are separate from production, are the managers of quality. It requires investment into identifying the appropriate processes and resources that must be controlled to meet Critical Quality Attributes.

Essential Elements of the Quality Management System.

At a minimum, QMS should include process performance and product quality monitoring, CAPA, change management, and management review. These systems are the essential elements to ensure that products meets Critical Quality Attributes, and that product quality is continuously improved.

Action you can take:

It’s no small challenge to build a Quality Management System. While we normally have direction actions, we feel it is highly valuable to have a 5-10 hour block with one of our consultants in order to set up the systems. If you prefer, you can directly hire a seasoned Quality Assurance manager, and they will be able to set your Quality Management System up from the start.

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What is Knowledge Management?

Knowledge Management requires total characterization and understanding of the manufacturing processes that lead to product realization – these activities form the foundation for applying Quality Management Systems and define how process variables are controlled to meet product specifications.

What is Risk Management?

Risk Management is the activity of identifying and characterizing all risks associated with degraded product quality and Key Performance Indicators. There are many variables that can influence product quality, and those must not only be identified,

Actions you can take:

Process knowledge starts with the Six Process Variables:

  1. Raw Materials
  2. Equipment
  3. Facilities
  4. Process Steps
  5. Labor
  6. Management

Characterize these six variables for any process, and you gain understanding and knowledge of your manufacturing processes. Take each of those variables and then weigh the risks of where something could go wrong and reduce product quality. It sounds simple, yet so apply this basic step of risk management.

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Critical Quality Attributes.

Quality Management Systems protect value chain stakeholders from the point of sourcing of raw materials to where consumers interact with the product. Quality Management Systems ensure products meet Critical Quality Attributes (CQA) – they are the minimum specifications that ensure a product is safe for humans to consume or use.

Total Control.

Quality Management Systems protect manufacturers maintaining a state of total control. Critical Quality Attributes describe the final product specifications, but the processes that proceed final product realization have variables that must be characterized and controlled in order to ever meet the Critical Quality Attributes.

Continuous Improvement.

Total control over manufacturing provides opportunities for Continuous Improvement and applications of Lean Six Sigma Management that improves all stakeholder positions – consumer perception improves and the manufacturing processes becomes more efficient. Quality Management Systems provide opportunities to identify the deviations that occur during the manufacturing process, and then ensure they never happen again.

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What is a Product Lifecycle?

Product lifecycle is categorized by the activities of Product Development, Technology Transfer, Manufacturing, and Product Discontinuation.

Stage 1 – Product Development.

Product Development includes formulations development, first-batch manufacturing, delivery systems, manufacturing process development and scale-up, and analytical method development. It is starting from ground zero, and includes all the activities of deciding on product market fit, specifications development, manufacturing process engineering, and setting the stage for Tech Transfer and Manufacturing.

Stage 2 – Technology Transfer.

Technology Transfer is the transfer of Manufacturing Intellectual Property from one division of a company to another, or a new company all together. Many companies have processes that could easily be outsources, and greatly expand their market reach. When developing a product, this issue should be considered, because it could greatly change the decisions you make in product development stages. It would be a risk if you did not develop your product and process for transfer, and be found to not have the requisite process knowledge to do it.

Stage 3 – Manufacturing.

If you are making a product for consumer use or consumption, you are most certainly in the manufacturing sector. This stage of the product lifecycle where most effort is spent. It is the major bottle neck of inefficiency, and if the manufacturing process is not adequately characterized and variables of inefficiency not controlled, the process will tank margins.

Manufacturing is described as the receipt and control of raw materials, equipment, facilities, process steps, labor, and management of the overall process leading to product realization. This major highway of the product lifecycle includes activities that encompass Quality Assurance and Quality Control, release, storage, and distribution of products.

Stage 4 – Product Discontinuation.

If you didn’t think of it during the Product Development Stage, you may have found your product market fit was not well vetted. Many more products fail to gain market acceptance than those that succeed. It’s a fact. This is often the use case for product discontinuation. Depending on your regulatory situation, it may be that manufacturing records and samples of each batch needed to be retained. Product Discontinuation is the process of handling such situations, and ultimately protecting the company from regulatory liabilities.

Action you can take:

Identify where your products are at in their lifecycle. Do you have documentation of your product development activities? Do you ever plan to do Tech Transfer? Have you identified important control points within the manufacturing process? Do you have a plan in place for maintaining records and samples from each batch?

These are important points to brainstorm and start documenting for the sake of controlling your manufacturing and preventing loss due to inefficiencies.

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