Vetting your Vendors is key to consistent Product Quality.

All materials or services from vendors must be vetted to ensure all activities and purchased product qualities meet appropriate pre-defined specifications. Botanically derived nutritional and dietary supplements are notorious for having variation, and vendors will ofter shirk their responsibility to confirm the Critical Quality Attributes of the materials they are selling. This puts the onus on the manufacturer to ensure their raw materials are qualified for use. All such vetting processes are risk management activities, where risks are weighed to ensure final product quality specifications will not be compromised.

Vendor Auditing.

Vendor auditing should occur to ensure suppliers and service providers are competent to fulfill their roles and provide materials in a fully characterized supply chain. Periodic vendor audits should be performed to ensure all agreements and specifications are met, and that product quality is continuously improved. All materials and services provided by vendors should be monitored for meeting quality specifications, managing risks to final product quality.

Vendor Agreements.

It is wise to have a vendor agreement that establishes the responsibility of the vendor to supply raw materials that meet the specifications your organization has set. This is a huge topic that is often glanced over, as we have observed in countless GMP audits in the pharmaceutical, nutritional and dietary supplement, cannabis, and cosmetics industries. Choose one quality vendor that consistently supplies high quality materials, and build a good relationship with them. Ultimately, Vendor Agreements are the art of relationship management in manufacturing. Choose your vendors wisely, treat them well, and they should do the like in return.

Action you can take:

Make a list of all the raw materials used in your manufacturing operation. Identify which vendors are supplying raw materials that are critical to product quality. Rank the raw materials by the relative risk they pose if they do not meet specifications. Then talk to to your vendors. Ask them about variation in their supply chains, and find the right vendor for the raw materials. Put effort into building your vendor relationships, and your product quality will grow in proportion.

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Continuous Improvement is the goal of every Quality Brand.

Products generally go through a 4 stage lifecycle that includes product development, technology transfer, manufacturing, and discontinuation. All stages of product lifecycle are controlled through the quality management system, and ensure final product quality is not compromised.

By understanding the 4 stage lifecycle of your product, you will better enable your organization to drive quality into the product from the start, and continuously improve product quality.

It starts with Product Development.

Product Development is the activity of designing the product and processes that lead to product realization. Product development focuses on ensure consistent product quality that meets the needs of patients and consumers, and should take into account all scientific research and process knowledge to make effective decisions.

Begin with the end in mind.

Technology Transfer follows product development, and aims to transfer product and process knowledge into the manufacturing environment and different sites of manufacturing while maintaining consistent product quality through product realization. Technology transfer establishes the foundation for manufacturing processes, manufacturing controls, manufacturing validation, and continuous improvement.

Active Manufacturing.

Manufacturing achieves product realization, or a readily deliverable product to patients or consumers. Manufacturing goals are to maintain a state of control and continuously improve product and processes. This ensures product quality specifications are met for every batch, key performance and process indicators are being maintained, appropriate controls based on risk analysis are used, and that products may be continuously be improved.

The end of the road.

No one likes to admit when it happens them, but not all products are successful with the market – interestingly, it is a category of continuous improvement. An organization will certainly get a better understanding of the market when a product fails to sell. That said, there need to be plans in place to control the products that are still on the market and ensure there is a “firewall” for to protect against claims of products not being safe for use.

Product Discontinuation ensures all records and samples of process and product are retained while discontinued products may still be circulating in the market, in reservation for recall events.

Action you can take:

Continuous Improvement is a buzz word in Quality Management Circles, but is often tough for organizations to deploy consistently. Because of the intricacies of the products, and the big picture nature of continuous improvement activities, we recommend getting all of your Quality Management Systems in place before undertaking the efforts of a Continuous Improvement program.

Quality Management Systems are the key to Continuous Improvement, and the use of those systems will inately get your organization on track for improving product quality. Use the systems, manage your process, and keep track of variation in all resources, and you will be on the right track. Just be sure to keep in mind the stage of product lifecycle, and keep and eye on the process variables.

If you have questions, contact us and we can give you the advice needed to keep on top of your Continuous Improvement.

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Management Review is key to Continuous Improvement.

Management is responsible for maintaining and using the Quality Management System and its periodic review. Such management audits ensure the systems are working as intended and are effective; audits should be used as tools to continuously improve product quality and identify process improvement opportunities, also to include improvement of the Quality Management System.

The Quality Policy and Quality Planning elements of the Quality Management System set the specifications for how product quality is engineered into every stage of manufacturing. Management Review is the follow through to ensure those specifications are being met at every stage of manufacturing. Management Review should happen at a quarterly basis, but is often an annual review. This sets the stage for fulfilling consumer demands, and makes sure consumer perception of the brand remains high.

Actions you can take:

Write the activities of your management team for reviewing Critical Quality Attributes, Variation in past batches, changes in the manufacturing processes, and any customer complaints of products. These are the minimum steps your organization can take to  ensure brand perceptions continuously improve in proportion to the improvement of product quality.

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Internal Communication has an impact on Product Quality.

Management is responsible for communicating all quality related matters in manufacturing, and ensuring the quality policy is implemented and used with the Quality Management Systems. Communication should be tracked for approval throughout the organizational levels, and ensure all quality related matters are fully completed and closed.

While it seems unnecessary to mention it, Internal Communication requires its own policy. It is the means of ensuring responsibilities and chain of custody of quality issues are communicated throughout the organization, and that no matters are dropped. It is easy for a company to talk about issues, but how those issues delegated to the responsible parties is essential for successful manufacturing.

Action you can take:

Start simple. Write out your organizational hierarchy, and detail who does what. What are the responsibilities? Who communicates with who? How and when should issues be communicated?

This is the fist step your organization can take towards establishing its internal communication policy.

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Resource Management.

Resource management is one of the most important aspects to total control manufacturing. It is the logistics of the organization – it is the right tools, materials, labor, and manufacturing conditions in the right place, at the right time. In smaller operations, managing these elements is often neglected, and is a root cause for inability to scale or perform tech transfer.

Materials used in manufacturing are allocated according to resources, processes, and product needs relative to raw materials, equipment, facilities, labor, and management, and are managed by the Quality department through the Quality Management System.

Action you can take:

Resource management starts with characterizing the logistics of your organization. We take a product based approach, listing out all resources need to take raw materials, etc, and turn them into a finished product. We are talking about total control, so this extends down to the lowliest of tasks such as daily sanitation activities and the resources needed to keep a sterile manufacturing environment. This sets your organization up with the minimum requirements for resource management that you can then build into your Quality Management Systems.

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Quality Policy.

A manufacturer’s Quality Policy describes the desired results for meeting quality specifications of products. The quality policy includes specifications on how the manufacturer meets regulatory requirements and how the QMS can be improved to meet organizational needs of continuous improvement. The quality policy applies to all employees involved in manufacturing.

Quality Planning.

Quality related matters are the direct responsibility of management and leadership. Quality planning is related to the quality policy, and internal auditing of meeting the specifications of that policy. All quality related matters must be supported to all personnel, and align with the quality policy. Key performance indicators of quality matters must be fully communicated and related to the quality policy.

Action you can take:

Start writing your organization’s quality policy by with making a list of the Critical Quality Attributes for each product being manufactured. Then write out what processes are related to each product, and what process specifications must be controlled in order to meet the product Critical Quality Attributes. These are the key steps to flesh out your quality policy.

You can not measure what you do not manage. Once you have a Quality Policy in place, you have set a baseline for managing your product quality. Develop a robust testing plan to measure your variation in meeting specifications. Develop in-process testing to ensure you are meeting process specifications before final release testing, and get the piece of mind that products are on track for meeting specifications before you send them to a 3rd party lab.

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Management Responsibilities.

Leadership and Management in a manufacturing environment is responsible for all success or failures of the organization. Yes, that is correct. When there are failures, it is a result of management not taking serious interest in the success of the company. If there is success, it is a result of leaders taking the right actions to organize and supervise all manufacturing operations.

The commitment of executive leadership in product quality is essential to meet critical quality attributes.  It is the responsibility of management to establish risk-based approaches to product quality and ensure specifications are met in all aspects of manufacturing. In our experience with auditing, the best companies have their executive leadership in the conference room, taking note of all opportunities for improvement.

Management Commitment.

Management is the responsible party for implementation and use of Quality Management Systems and Good Manufacturing Practices, and use these systems to ensure targeted Quality Objectives are met. Management starts with defining all roles and jobs within the organization, delegating appropriate authority, an communicating the desired results for the organization.

This is not an easy job, and it again, starts with understanding the Critical Quality Attributes of the products, and ensuring all process specifications are consistently met. When Critical Quality Attributes are not met, management through Corrective Action and Preventative Action ensures that the next batch will meet those specifications.

Action you can take:

There is a saying in the Marine Corps: “Leaders eat last.” Leaders will, however, have to take the majority of this task on themselves. Establishing the relationship of leaders relative to the manufacturing processes is a intricate process of applying the fields of Industrial Organizational Psychology, Organizational Development, and Change Management.

Giving us a call to help you strategize on your leadership responsibilities and we will give you the action plan.

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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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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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Vendor Agreements

Vetting your Vendors is key to consistent Product Quality. All materials or services from vendors must be vetted to ensure all activities and purchased product qualities meet appropriate pre-defined specifications. […]

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Continuous Improvement

Continuous Improvement is the goal of every Quality Brand. Products generally go through a 4 stage lifecycle that includes product development, technology transfer, manufacturing, and discontinuation. All stages of product […]

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Management Review

Management Review is key to Continuous Improvement. Management is responsible for maintaining and using the Quality Management System and its periodic review. Such management audits ensure the systems are working […]

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DEA/FDA Schedule 1 Cannabis Manufacturing – GMP Cannabis

The Challenge to the Industry We have a civic responsibility to take action and improve the lives of those that we have the ability to do so. Orion GMP Solutions […]

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Internal Communication

Internal Communication has an impact on Product Quality. Management is responsible for communicating all quality related matters in manufacturing, and ensuring the quality policy is implemented and used with the […]

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Resource Management

Resource Management. Resource management is one of the most important aspects to total control manufacturing. It is the logistics of the organization – it is the right tools, materials, labor, […]

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Quality Policy and Planning

Quality Policy. A manufacturer’s Quality Policy describes the desired results for meeting quality specifications of products. The quality policy includes specifications on how the manufacturer meets regulatory requirements and how […]

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Management Responsibilities and Commitment

Management Responsibilities. Leadership and Management in a manufacturing environment is responsible for all success or failures of the organization. Yes, that is correct. When there are failures, it is a […]

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Quality Manual

What is a Quality Manual? The Quality Manual documents all aspects of the organization’s policies and procedures of the Quality Management System. It is the 1000 Meter view (yes, we […]

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