QMS-GPP Planning According to ISO:9000

Introduction

Quality management is the practice of ensuring consistency in products and services throughout your organization. A Quality Management System (QMS) helps your cannabis business provide customers with the best you can offer while mitigating risks using tools that support Health Canada’s Good Production Practices.

A Quality Management System-Good Production Practices Plan provides an overview of the quality management system that an organization has in place. Although there are many standards in the world, ISO:9000 is one of the most respected. And according to ISO:9000 standards, the plan must contain the following.

Quality Policy (ISO:9000 clause 5.2): A quality statement can be derived from a mission statement and/or vision statement, but should explain the organization’s commitment to quality

Quality Objectives (ISO:9000 clause 6.2): These can be the organization’s objectives from a business plan, again, as long as they contain a commitment to quality

Criteria for Evaluation and Selection of Suppliers: As quality management and good production practices are often dependent on supplies and equipment that come from other organizations, organizations need to have a criteria in place for evaluating their suppliers to ensure that they select suppliers that meet QMS and GPP standards

Scope of the QMS: This is a list of all SOPs with brief descriptions/purposes

Quality Product Statement

ISO:9000 requires your organization’s quality policy to be appropriate to your organization’s strategic direction and operational direction (context).

Your organization must understand and identify all the influences that affect its business and ensure that the strategy and direction takes quality into consideration. Your organization will need to review its current quality policy regularly to ensure that any changes in context, interested parties or other requirements are reflected, and to determine whether your organization’s objectives are affected. (ISO 9001:2015 – 6.2.1a.)

Following is an example.

Company ABC produces cannabis products for distribution in Canada according to the regulations in the Cannabis Act. The Company has developed its production system through experience and its aim is to achieve a high standard of production and products to its customers.

It is the policy of Company ABC to provide the customer with goods to the agreed requirement in accordance with the details and price.

The Directors, Management and Staff are responsible for Quality Control through the Quality Management System seeking improvement by constant review, with suppliers and sub-contractors being encouraged to co-operate. The Company is committed to achieving customer satisfaction by the use of quality procedures which will be operated to meet or exceed the requirements of [the Cannabis Act and/or ISO 9001 or other quality system].

Quality Objectives

The quality objectives should act as a driver for continual improvement. To meet quality standards, your organization will be required to ensure that you continually improve products and services to meet customer requirements and to measure effectiveness of the processes responsible.

Following is an example.

Company ABC strives to be the best provider of cannabis products in Canada. Through the use of this guiding principle, everyone in Company ABC is accountable for fully satisfying our customers and authorities by meeting or exceeding their needs and expectations with best-in-class production practices. Our goal is 100% customer satisfaction and compliance 100% of the time.

Our Quality Policy is defined and strongly driven by the following objectives:

1. Meet all compliance requirements for all levels of governments and regulatory agencies

2. Build a mutually profitable relationship with our customers, ensuring their long-term success, through the understanding of their needs and the needs of their customers as well

3. Achieve our commitments for quality, cost, and schedule

4. Use of best preventive practices at all levels and ensure reliable risk management

5. Drive continual improvement and innovation based upon efficient business processes, well-defined measurements, best practices, and customer surveys

6. Develop staff competencies, creativity, empowerment and accountability through appropriate development programs and show strong management involvement and commitment

Evaluation and Selection of Suppliers

Supplier evaluation is a system for recording and ranking the performance of a supplier in terms of a variety of criteria and is a must in ISO:9000. A process of vendor rating is essential to effective purchasing. While there is no one right system for supplier evaluation and selection process, the overall objective is to reduce risk and maximize overall value to the purchaser.

Criteria

There are eight common supplier selection criteria:
1. Cost
2. Quality & Safety
3. Delivery
4. Service
5. Social Responsibility
6. Convenience/Simplicity
7. Risk
8. Agility

In the cannabis industry, you should also add a commitment to meeting compliance and/or helping their customers meet compliance.

Methods

There are many other methods of evaluation, and the organization should determine which is the best for its use.

Categorical systems typically use excellent, good, average, poor and so on.

Weighted systems rate on a scale from 1 to 10 or out of 100.

Hierarchical systems give values in relation to each item’s importance. The most important item is given the highest value.

Conclusion

Of course, a quality management system and good production practices plan is only as good as the processes that support it. Creating standard operating procedures and ensuring that all personnel follow them will give you the best chance of success.

For more information about ISO:9000 visit: ISO – ISO 9000 family — Quality management

For information on how AirMed helps you meet compliance, visit our Compliance page.

If you’d like to learn about our quality management and GPP offerings or discuss your specific needs, please give us a call at 1-877-313-2442 or use one of the contact forms.


Cannabis in Canada: Get the Facts

Do you have questions about cannabis in Canada? Would you like to understand the laws that govern the Canadian cannabis industry? Are you considering applying for a license to cultivate, process or sell cannabis?

The federal government has a webpage that outlines what industry needs to know about cannabis in Canada. This information covers the basics related to doing business in the cannabis industry including:
Impact of the new law and regulations on industry

  • Applying for or amending a federal licence
  • Packaging and labelling requirements
  • Cannabis Tracking and Licensing System requirements
  • Compliance and enforcement under the Cannabis Act
  • Prohibitions on promotions
  • and more

The page provides links to relevant sections of the federal government website where you can find more information on each topic.
https://www.canada.ca/en/services/health/campaigns/cannabis/industry.html

For more information on how AirMed helps you meet compliance, visit our Compliance page or our Frequently Asked Questions page. If you’d like to discuss your specific needs, please give us a call at 1-877-313-2442 or use one of the contact forms to start the ball rolling.


FREE Seed-to-sale Software Buyer's Guide

Record keeping is an essential part of Health Canada’s compliance regulations. From the advent of legal medical marijuana in Canada, legal producers of cannabis have been required to track every seed, rooted plant, gram of waste material, final dried product, as well as interactions with customers and more. Due to the sheer volume of information, an electronic record-keeping system is the only practical way to manage the process. The software industry has responded to this need by creating seed-to-sale management software systems designed to help producers track their operations and report to Health Canada to meet compliance.

To help you through the process of purchasing seed-to-sale software in the Canadian Cannabis marketplace, we've produced a 20-page guide that answers the following questions:

  • What is a seed-to-sale software solution and why do I need one?
  • How do I choose one software platform over another?
  • What should I be looking for in the software?
  • How does the software fit into my business?
  • How is my data stored and secured?
  • What happens if regulations change?

To download this guide courtesy of AirMed, please visit the following page and complete the form. Once you submit the form, you'll be able to download the guide.

AirMed Seed-to-Sale Software Buyer's Guide


FREE Seed-to-sale Software Buyer's Guide

Record keeping is an essential part of Health Canada’s compliance regulations. From the advent of legal medical marijuana in Canada, legal producers of cannabis have been required to track every seed, rooted plant, gram of waste material, final dried product, as well as interactions with customers and more. Due to the sheer volume of information, an electronic record-keeping system is the only practical way to manage the process. The software industry has responded to this need by creating seed-to-sale management software systems designed to help producers track their operations and report to Health Canada to meet compliance.

To help you through the process of purchasing seed-to-sale software in the Canadian Cannabis marketplace, we've produced a 20-page guide that answers the following questions:

  • What is a seed-to-sale software solution and why do I need one?
  • How do I choose one software platform over another?
  • What should I be looking for in the software?
  • How does the software fit into my business?
  • How is my data stored and secured?
  • What happens if regulations change?

To download this guide courtesy of AirMed, please visit the following page and complete the form. Once you submit the form, you'll be able to download the guide.

AirMed Seed-to-Sale Software Buyer's Guide


What happens with my seed-to-sale software if regulations change?

The market for cannabis is evolving. Health Canada manages oversight and sets the compliance requirements for legal production of cannabis in Canada. In the last five years, these requirements have changed multiple times and are set to change again with the legalization of cannabis for recreational use on October 17, 2018. A responsible software vendor will ensure that all its clients have the information they need to comply with the latest Health Canada requirements.

With SaaS or cloud-based seed-to-sale platforms, software updates are usually global to all clients/users. On-site implementations sometimes require individual upgrades performed by the client in conjunction with the vendor. Often this means scheduling both parties, which can delay access to the latest features and functionality. If there are modifications for specific clients, this can mean a complicated upgrade path with the risk of unintended software bugs and related down time or additional costs to re-customize.

As you choose your seed-to-sale software solution, be sure to consider the future of compliance and those implications on your business. No one knows for sure what the future holds, but history has shown that the only true constant is change.

For more information about the Cannabis Act in Canada visit: What you need to know about cannabis – Canada.ca

For more information, download our software buyer’s guide here: How to Purchase Seed-to-Sale Software


Why you need seed-to-sale software for your cannabis business

Licensing

To do business in the cannabis industry in Canada, you must meet Canada’s licensing requirements. Currently there are several types of licenses for those wishing to carry out cannabis-related business in Canada.

  1. Standard Cultivation
  2. Micro-cultivation
  3. Nursery
  4. Standard Processing
  5. Micro-processing
  6. Sale
  7. Analytical Testing
  8. Research

Regardless of which class of license you get, you will be responsible for complying with all the regulations that apply from the various levels of government.

 

The Laws

The Cannabis Act

Formerly called the ACMPR, this act covers all aspects of cannabis in Canada from growing through processing to selling and more. It is the responsibility of the licensee/applicant to understand and meet all the requirements that apply to their business.

Other Federal Acts and Regulations

As a licensee or applicant, you are responsible for complying with requirements of other Canadian acts and regulations such as the Food and Drugs Act (FDA), the Pest Control Products Act, the Fertilizer Act, among others.

The Canada Revenue Agency

You’ll also need to meet requirements of the Canada Revenue Agency depending on which activities will be conducted with cannabis.

Provincial or Territorial Legislation

As a licensee or applicant, you’ll be responsible for complying with all applicable provincial or territorial laws and regulations (environmental laws, for example).

Municipal By-Laws

As well, you’ll need to deal with municipal by-laws such as zoning and building permits.

 

How can seed-to-sale software help?

From the advent of legal medical marijuana in Canada, legal producers of cannabis have been required to track every seed, plant, gram of waste material, final product, and more. Due to the sheer volume of information, an electronic record-keeping system is the only practical way to manage the process.

The software industry has responded to this need by creating seed-to-sale management software designed to help businesses meet compliance. Seed-to-sale software tracks growth, harvesting, processing, packaging, sales and distribution.

And some seed-to-sale software systems go beyond compliance to help businesses cultivate success with features and functionality to help fine-tune propagation, growth cycles, harvesting, production, derivatives, inventory, staffing, and product sales. AirMed is one of those. Wherever your business fits in the seed-to-sale supply chain, AirMed can help with both legal compliance and business acumen. For a free demo, call 877-313-2442, email info @ airmed.ca or fill out the form on our contact page.

 

For information on cannabis licensing in Canada visit: Cannabis Licensing Application Guide

 

For more information on purchasing seed-to-sale software, fill out a form to download our complete buyer's guide: Seed-to-sale Software Buyer's Guide


ACMPR and the licensed cannabis producer

What does ACMPR cover?

For the cannabis industry in Canada, the most critical compliance implications are those covered by the Access to Cannabis for Medical Purposes Regulations. This legislation covers every aspect of marijuana production and sale. Overseen by Health Canada, these regulations must be adhered to at every stage of cannabis business from propagation through to sale. As of August 24, 2016, the Access to Cannabis for Medical Purposes Regulations (ACMPR) replaced the previous Marihuana for Medical Purposes Regulations (MMPR).

ACMPR is designed to provide an immediate solution for Canada to meet legal requirements. But Health Canada is continuously evaluating how a system of medical access to cannabis should function alongside the government's commitment to legalize, strictly regulate and restrict access to cannabis. As a result, laws and regulations may change.

Currently, the legislation contains four parts.

Part 1 sets out a framework for commercial production by licensed producers responsible for the production and distribution of quality-controlled fresh or dried marijuana or cannabis oil or starting materials (i.e., seeds and plants) in secure and sanitary conditions.

Part 2 sets out provisions for individuals to produce a limited amount of cannabis for their own medical purposes or to designate someone to produce it for them.

Parts 3 and 4 include transitional provisions, consequential amendments to other regulations, and provisions repealing the MMPR.

All those wishing to produce cannabis in Canada must apply to Health Canada to become a licensed producer under the ACMPR legislation, and all licensed producers MUST comply with the ACMPR regulations.

What are the specific ACMPR regulations that affect software and record keeping?

The ACMPR has many regulations that apply to the medical marijuana industry in Canada as a whole. Not all of those have implications for record keeping or to the method (software) used for that record keeping. (For links to the different websites that cover ACMP download our Seed-to-Sale Software Buyer’s Guide.)

How do I meet ACMPR compliance?

To be ACMPR compliant, your organization must have ways of meeting all of the regulations listed above.

Many of the regulations listed above apply to processes, so you’ll need to be utilizing best practices and documented standard operating procedures. You’ll also need to be able to prove to Health Canada that you have used best practices. That’s where seed-to-sale software comes in. Your cannabis business management software should provide you with the means to meet compliance when it comes to record keeping and reporting.

To support you in this process, a viable software vendor will supply you with a document that outlines exactly how the system they provide meets those requirements.

For a free demo to learn how AirMed meets these and other regulations, please email info @ airmed.ca.


What is seed-to-sale software and why do I need it?

Seed-to-sale software tracks plant production from reproduction through growth, harvesting, drying, packaging, sales and distribution. Health Canada mandates record keeping for every part of the process, and Canadian seed-to-sale software applications focus on compliance built on Health Canada’s ACMP (Access to Cannabis for Medical Purposes) regulations.

Record keeping is an essential part of Health Canada’s compliance regulations. From the advent of legal medical marijuana in Canada, legal producers of cannabis have been required to track every seed, rooted plant, gram of waste material, final dried product, as well as interactions with customers. Due to the sheer volume of information, an electronic record-keeping system is the only practical way to manage the process. The software industry has responded to this need by creating seed-to-sale management software systems designed to help producers track their operations and report to Health Canada to meet compliance.

As a Health Canada applicant, you must specify the name of the software system you plan to use for record keeping and provide a summary of how the software program meets Health Canada’s requirements. As a result, you will need to make at least preliminary decisions into seed-to-sale management software early on in your application process.

This might seem like one more challenge along your path to becoming a licensed producer, but in reality, seed-to-sale software is designed to help you be successful.

Seed-to-sale software platforms should provide the electronic record keeping required to not only for you to meet compliance, but also to help you be successful in your business. From greenhouse to warehouse to customer, your software system should help you at every stage of your operation. Functionality for genetics tracking, inventory management, quality control, shipping & receiving, point-of-sale ecommerce, compliance auditing & reporting, and customer relationship management can provide you with full business administration.

What is ACMPR and how does it affect me?

What does ACMPR cover?

For the cannabis industry in Canada, the most critical compliance implications are those covered by the Access to Cannabis for Medical Purposes Regulations. This legislation covers every aspect of marijuana production and sale. Overseen by Health Canada, these regulations must be adhered to at every stage of cannabis business from propagation through to sale. As of August 24, 2016, the Access to Cannabis for Medical Purposes Regulations (ACMPR) replaced the previous Marihuana for Medical Purposes Regulations (MMPR).

ACMPR is designed to provide an immediate solution for Canada to meet legal requirements. But Health Canada is continuously evaluating how a system of medical access to cannabis should function alongside the government’s commitment to legalize, strictly regulate and restrict access to cannabis. As a result, laws and regulations may change.

Currently, the legislation contains four parts.

Part 1 sets out a framework for commercial production by licensed producers responsible for the production and distribution of quality-controlled fresh or dried marijuana or cannabis oil or starting materials (i.e., seeds and plants) in secure and sanitary conditions.

Part 2 sets out provisions for individuals to produce a limited amount of cannabis for their own medical purposes or to designate someone to produce it for them.

Parts 3 and 4 include transitional provisions, consequential amendments to other regulations, and provisions repealing the MMPR.

All those wishing to produce cannabis in Canada must apply to Health Canada to become a licensed producer under the ACMPR legislation, and all licensed producers MUST comply with the ACMPR regulations.

What are the specific ACMPR regulations that affect software and record keeping?

The ACMPR has many regulations that apply to the medical marijuana industry in Canada as a whole. Not all of those have implications for record keeping or to the method (software) used for that record keeping. (For links to the different websites that cover ACMP see More Information at the end of this document.)

How do I meet ACMPR compliance?

To be ACMPR compliant, your organization must have ways of meeting all of the regulations listed above.

Many of the regulations listed above apply to processes, so you’ll need to be utilizing best practices and documented standard operating procedures. You’ll also need to be able to prove to Health Canada that you have used best practices. That’s where seed-to-sale software comes in. Your cannabis business management software should provide you with the means to meet compliance when it comes to record keeping and reporting.

To support you in this process, a viable software vendor will supply you with a document that outlines exactly how the system they provide meets those requirements.

For more information on seed-to-sale software, download our buyer’s guide, which answers to the following questions.

What does seed-to-sale software cost?

How do I choose one software platform over another?

What should I be looking for in the software?

How does the software fit into my business?

How is my data stored and secured?

What happens if regulations change?

Download the buyer’s guide here: How to purchase seed-to-sale software

For a free demo to learn how AirMed meets these and other regulations, please call 1-877-313-2442, use clikc the Request Demo button or email info@airmed.ca.