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.

More articles like this one:

ASTM D37: Cannabis Standardization through Collaboration

What is ASTM? ASTM International is a Standards Organization that generates internationally accepted standards for multitude of industrial and consumer products. Without standards, Industries are left to market forces, and […]

0 comments

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. […]

0 comments

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 […]

0 comments

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 […]

0 comments

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 […]

0 comments

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 […]

0 comments

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, […]

0 comments

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 […]

0 comments

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 […]

0 comments

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 […]

0 comments

 

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.

More articles like this one:

ASTM D37: Cannabis Standardization through Collaboration

What is ASTM? ASTM International is a Standards Organization that generates internationally accepted standards for multitude of industrial and consumer products. Without standards, Industries are left to market forces, and […]

0 comments

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. […]

0 comments

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 […]

0 comments

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 […]

0 comments

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 […]

0 comments

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 […]

0 comments

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, […]

0 comments

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 […]

0 comments

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 […]

0 comments

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 […]

0 comments

 

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.

More articles like this one:

ASTM D37: Cannabis Standardization through Collaboration

What is ASTM? ASTM International is a Standards Organization that generates internationally accepted standards for multitude of industrial and consumer products. Without standards, Industries are left to market forces, and […]

0 comments

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. […]

0 comments

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 […]

0 comments

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 […]

0 comments

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 […]

0 comments

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 […]

0 comments

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, […]

0 comments

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 […]

0 comments

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 […]

0 comments

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 […]

0 comments

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.

More articles like this one:

ASTM D37: Cannabis Standardization through Collaboration

What is ASTM? ASTM International is a Standards Organization that generates internationally accepted standards for multitude of industrial and consumer products. Without standards, Industries are left to market forces, and […]

0 comments

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. […]

0 comments

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 […]

0 comments

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 […]

0 comments

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 […]

0 comments

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 […]

0 comments

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, […]

0 comments

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 […]

0 comments

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 […]

0 comments

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 […]

0 comments

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 use the metric system) of how Product Quality is Managed, by managing the manufacturing process.

The quality manual can also include the Site Master File. The Site Master File explains all activities that take place within a Good Manufacturing Practices Facility, and is often the first place an auditor will look. It is often a document that is found to be out of date, and not matching the actual day-to-day operations in a manufacturing facility – that is why your organization should have the Quality Manual and Site Master File in good working order.

What are the elements of a Quality Manual?

  1. The Quality Policy is the organization’s stance on how they meet quality goals. It deliberately sets the standards of the organization’s quality goals. How can your organization meet quality goals if it does not have a policy in place? It is the corporate equivalent of a Mission Statement, except it directly relates to Quality.
  2. The scope of the Quality Management Systems describes what aspects of the manufacturing processes are controlled and monitored. The Quality Management System Scope will define what departments are affected, who is involved, and how quality related matters are handled.
  3. The description of the Quality Management System processes that are used to manage the manufacturing processes. This includes a Product Quality Assessment System (determines if Critical Quality Attributes are being met), Corrective Action and Preventative Action systems (to correct process problems and ensure they don’t happen again), Change Management Systems (ensure that Corrective/Preventative Actions are properly executed and closed out), and Management Review (to ensure processes are producing products meet Critical Quality Attributes).
  4. Management responsibilities describe the exact activities and responsibilities of leadership and management. Management is responsible for ensuring the process is being managed, instead of the labor being managed. Although it may seem to be redundant to suggest Quality Management Systems need to be Managed, it is the most essential set of responsibilities to ensure product quality is kept high. Management is most responsible for quality.

Action you can take:

Writing your Quality Manual takes time and careful thought. It requires complete knowledge of the manufacturing process, and understanding of the product lifecycle. At the very least, brainstorm how the elements of the Quality Manual and start putting together a rough draft. These documents do not spontaneously generate, and you will need to take an iterative approach that embodies the concept of “Continuous Improvement.”

More articles like this one:

ASTM D37: Cannabis Standardization through Collaboration

What is ASTM? ASTM International is a Standards Organization that generates internationally accepted standards for multitude of industrial and consumer products. Without standards, Industries are left to market forces, and […]

0 comments

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. […]

0 comments

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 […]

0 comments

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 […]

0 comments

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 […]

0 comments

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 […]

0 comments

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, […]

0 comments

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 […]

0 comments

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 […]

0 comments

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 […]

0 comments