Optimizing Operation Processes through Quality Management Systems

Tom Shipley2017-03-22

• Reproductive Toxicology with Health Canada– Included collaborative projects

with EPA • Viral Vaccine Regulation with

Health Canada– Lot release of vaccines

• Quality Assurance for Tweed

Speaker Background:

• Purchase of Hershey Chocolate Factory in 2013.

– 5 employees, ~4000 sq ft. • Begin Greenhouse production in 2014.

– ~ 22,000 sq ft. • Production of extracts in 2015.• Production of 11,605.133 lbs in 2016.• First Million dollar day Feb 1st, 2017.

– ~360 employees, 18,463lbs in inventory.336,000 sq ft grow space.

• Once company - Production, extraction, sale direct to customer by mail.

Company Background:

• A Method of:– Organizing production processes.– Reviewing, monitoring and maintaining assets.– Tracking training of staff.– Reducing the cost of poor quality.

What is a Quality Management System?

Why is it Important? • Scalability:

– Facilitates duplication of processes, sites resulting in exponential growth.

• Safety:– Ensures review of procedures, equipment,

materials and supplier agreements. Preventing unforeseen circumstances.

• Operational efficiency:– Forces business case surrounding operational

decision making.• Decreased operational costs • Increased product quality

A Cost of Poor Quality: Public Recalls• Organigram (pesticide recall – pesticide use)

– All Cannabis produced in 2016– Aurora purchased 7 lots from Organigram which

were subsequently recalled. • Aurora

– Incorrect THC labeling.• Peace Naturals

– Incorrect THC labeling.– Over bacterial limit.

• Tilray– Three lots over bacterial limit.– Capsule recall (Croatia export).

A Cost of Poor Quality: Public RecallsRecalls result in:• Decreased sales due to loss of

consumer trust• Increased Op-ex from:

• Contacting effected clients.• Managing return shipment and

refunds• Regulatory affairs (rebuilding

trust) • Loss of inventory leading to

immediate loss of revenue• Legal costs from class action lawsuits

Important Elements - Software: • Controls:

– User controls based on role within the company give the employee the tools they require, without providing the ability to make decisions outside of their scope of responsibility.

• Traceability: – Who made a decision and when.

• Input Configurability and Reporting:– To track key performance indicators.

Examples of Solutions: • Google corporate or similar (eg. Microsoft,

MySQL)– User controls, traceability, real time document

sharing. Data entry with data validation. Script support.

• Out of box 21 CRF Part 11:– Out of box and validated to perform the way it

should (no bugs or glitches)– Required in a FDA / GMP environment. – Often cloud based and/or digital signature support.

• EPR Service Provider:– Eg SAP. Full integration of Production, Sales ,

Forecasting, Finance, and Human Resources.

The Standard Operating Procedure• Gain control over a critical process within the company by ensuring

it follows an SOP.• Level of detail is dependent on intention.

– Required by regulations– Ensures proper training of staff– What are the KPI’s? How can they be measured? – Allow flexibility in a procedure

• Written process ensures procedures are being performed, consistently, correctly, and facilitates exponential training.

The Generic SOP suite:• All QMS:

– Creation and revision– Change management– Non conformities– Corrective and preventative action– Training– Record keeping

• Overarching– Facilities management– Equipment management– Material management – Supplier management– Client management

• Business specific– Clone– Veg– Flower– Harvest– Dry– Cure– Package– Cleaning– Extraction– Quality reviews

Building the Culture • Training records signed and dated by both the qualified

trainer and trainee– Level of training dependent on task

• Read and Understand• Observe• Perform with supervision• Perform independently

• Training records are a method of creating accountability.

• Define requirements and how they will be achieved. • Is the SOP working the way it was intended?

– If not, what is the root cause and indirect cause(s)?– Is the data being collected and organized in a way which

facilitates analysis?• Becomes autonomous process for continual improvement. • Creates optimized processes which gain value as they are

scaled.

The Plan, Do, Check, Act cycle

A Cost of Poor Quality: Poor Training • Can lead to dangerous environment for the workers.• Inconsistency in product.• Anomalies in product quality. • Employees follow un-optimized process.• No involvement from employee in suggesting

improvements. – Lack of culture can lead to downward spiral

• Providing the tools (software, hardware)• Guidance, training, support• Setting clear goals• Supporting positive

morale

It Starts with Management

Questions?

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