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Stringent quality assurance (QA) systems, and having highly trained personnel in place are the hallmarks of a QAP’s responsibility. Some of the defining characteristics of QA in cannabis operations and laboratories include standard operating procedures (SOPs) for guidance; a working lab functions according to requirements, including compulsory record keeping, data analysis and internal audits; record keeping and individuals tasked with correcting problems; and personnel who must deliver high-quality performance. Within Canada’s cannabis industry, the objective is to provide a safe supply to consumers, dependent upon strict quality control and consistent product quality.
Starting a QA program
Av Singh, PhD, PAg, agronomist and cannabis consultant, believes “the easiest way to work into a QA program is by conducting a self-audit,” he says. “With most clients, we use a weekly checklist we employ as we walk through a facility and do a quick Good Documentation Practices review to make sure we are capturing deviations from our SOPs and recording other Change Control measures. In walking through, it becomes easy to point out that we think a SOP is attaining the desired goal.”
Who is the quality assurance person (QAP)?
As a burgeoning industry navigating regulatory compliance, “the cannabis industry had to “steal” professionals from the food industry, from pharma, even from labs,” comments Mariana Black, QAP and chief compliance officer at Ontario LP GlassHouse Botanics. Black notes QAPs come from “quality management systems” and “farm food safety programs.”
As the industry is new, the personal attributes of an individual are also important.
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What qualifications do QAPs have?
Kevin Clark, director of operations and QAP at Eco Canadian Oganic Inc. says “a strong QAP requires experience in consumer goods such as food and beverage with enhanced education and/or several years of managerial experience in science, processing, manufacturing practices, and food processing.”
What do QAPs do?
QAPs, Black says, “have a broad scope of work within the operation of a licensed producer. They are responsible for ensuring compliance to regulations and for approving the procedures that outline how these activities are carried out.”
While an ability to uphold rules and standards is important, so is the ability to be intellectually agile as duties and the marketplace change. A QAP’s responsibilities vary. They must possess strong problem-solving, communication and analytical skills, along with emotional resilience to handle challenges effectively. “The role can expand to managing production, packaging design, negotiating pricing, value engineering and client management,” comments Clark.
Daily duties
On a day-to-day basis, Black is “overseeing compliance to regulations and conformance to procedures.” She says, “my duties involve deviation and CAPA management; batch review for release; managing the change control process; managing communications with our buyer’s quality staff; and managing the quality team.”
Clark’s day begins with “a meeting with my staff followed by a meeting with my owners to prioritize our day and confirm weekly requirements.” Daily, Clark will “supervise activities in the facility and/or participate. I then would connect with my farmgate manager and consult on inventories and begin documentation review and planning scheduling to meet production requirements to strategic business development.”
Monthly duties
Black’s monthly responsibilities involve ensuring that “we stay compliant to Good Production Practices (GPPs), Good Agricultural Collection Practices (GACPs), and Good Manufacturing Practices (GMP).”
If a company did analytical testing on their premises, Black notes, “the QAP would ensure that the testing is conducted as per procedures in a manner to ensure they are accurate and remain in validated status and/or are completed as per compendial methods.”
Clark’s monthly duties range from “planning scheduling, human resources, hiring, product development, packaging design, sales, production management, material procurement, and managing relations with our patients, clients and customers.”
Fluency in technology is an essential part of a QAPs’ skill set. “To comply with GPPs you need to understand how to properly manage equipment so that it functions as intended.” Black comments.
QAPs have well-developed social intelligence wherein diplomatic skills are essential.
At the same time, there is an element of emotional toughness to being a QAP. Black observes: “as QAP you are that one person that tends to tell operations and senior management that something cannot be done.”
What keeps a QAP up at night?
“Everything,” Clark states. “In a leadership role, your executives rely on your foresight. What keeps me up at night – ‘the what if’ scenarios – which helps me plan and execute actions more effectively.”
J. Lynn Fraser is a trade media journalist and freelance writer from Ontario.
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