Tag Archives: corrective

Radojka Barycki picture

Preparing Your Recall Strategies

By Radojka Barycki
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Radojka Barycki picture

A product recall is the removal of a defective product from the market because it can cause harm to the consumer or place the manufacturer at risk of legal action.

Although a recall is not something that companies want to be related to, preparing for it is very critical and it is an important part of crisis management.Product recalls can cost companies million dollars in profit loss and civil damages. The company senior management and employees can also face criminal action, if the investigation shows negligent acts. The company will also face loss of reputation and the trust of its customers.

Although a recall is not something that companies want to be related to, preparing for it is very critical and it is an important part of crisis management.

There are several phases when preparing a recall strategy:

Planning Phase

During the planning phase, a recall plan is developed. A recall plan is the procedure that will be followed by an appointed company’s team during an actual recall. A good recall plan will have the following components:

  • Definitions of the type of products recalls. According to federal regulations, there are three types of recalls. The company should know what type of recall they are performing to understand the risk the consumer is facing.
  • A Recall Team. The recall team is the key stakeholders that are responsible for different processes within the company. A good recall team will be multidisciplinary. A multidisciplinary team is a group of people that have different responsibilities within the manufacturing site (i.e. Receiving Manager, QA Manager, etc.) and/or outside (i.e. Legal Counsel, Public Relations, etc.) 
  • A description of the recall team member’s responsibilities must be outlined. A recall coordinator and a backup should be assigned to ensure that there is one person organizing all activities during the recall. 
  • A Communication Plan. It is important that only the appointed person that has the responsibility of external communications (i.e. media, regulators, customers, key stakeholders, etc.). In addition, there should be only one person appointed to handle all the communication within the team (internal communications.)
  • Documents to be used during the recall are:
    • Communication documents: Letters to customers, regulators and media must be drafted and kept on hand for use during the crisis.
    • Forms that will be used to keep track of product inventory on hand (still in the site), product being returned and product being destroyed.
  • A Traceability Procedure should be in place to ensure that materials used in the manufacturing of the finished good can be traced from the time of the delivery to the facility and throughout the product manufacturing process. In addition, traceability must also be provided for finished goods from the manufacturing site to its first point of distribution. This is known as traceability one step back (materials used) and one step forward (first point of distribution.)

    PlantTag
    A plant tagged with a barcode and date for tracking
  • A description of (or reference to) product quarantine (product hold) procedures that must be followed to ensure that the product that is still at the site do not leave the facility. 
  • Product Destruction The company must outline (or reference) how product will be destroyed during a recall process.

Implementation Phase

There are three processes that need to be followed when implementing the recall plan:

  • Training: The recall team must be trained on their roles and responsibilities. Employees working at the site will be receiving directives from the appointed recall team members. It is also important that they are aware about the recall plan and understand the importance of urgency during the situation.
  • Exercise: It is important that the company doesn’t wait until the incident occurs to ensure that everyone in the team understands their roles and responsibilities during the recall. Therefore, annual testing of the procedure is imperative. This implies creating a “mock recall” situation and providing the information to the team to evaluate if they fully understand their role and responsibilities. This also allows the testing of the traceability protocols and systems that have been put in place by the site. Ensure that the team understands that this is an exercise and not an actual recall. You don’t want the team members going through the emotions that an actual recall gives. However, stress the importance of their participation during this exercise. You do not communicate to customers, media or regulators during a recall exercise. 
  • Execution: This is the actual recall and full implementation of the plan. During the actual recall, you communicate to the regulators, customers and media. The company must also conduct daily recall effectiveness checks by using the forms developed for tracking product inventory, recovery and destruction. 
  • Identify root cause and implement corrective actions. Root cause(s) will be identified during the recall process by analyzing the information resulting from the investigation of the incident. Regulatory agencies will actively participate in the discussion for identifying in the implementation of corrective actions. 

Improvement Phase

The recall team should always meet after the recall exercise or the actual recall incident. The team must evaluate what positive or negative outcomes resulted from the process. If there are gaps identified, these need to be closed, so the process is improved.

Soapbox

Human Error? No Problem

By Dr. Ginette M. Collazo
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If you are in the business of growing cannabis, you should be aware of the common reasons for production losses, how to address root causes and how to prevent future occurrences in a sustainable way. Human error is the number one root cause identified in investigations for defects in the cultivation business. Sadly, little is known about the nature of these errors, mainly because our quest for the truth ends where it should begin, once we know it was a human error or is “someone’s fault.”

Yes, human error usually explains the reason for the occurrence, but the reason for that error remains unexplained and consequently the corrective and preventive actions fail to address the underlying conditions for that failure. This, in turn, translates into ineffective action plans that result in creating non-value added activities, wasting resources and money as well as product.

Human error can occur when workers are in direct contact with the plant

So after investigating thousands of human error events and establishing systems to improve human reliability in manufacturing facilities, it became even clearer to me, the need to have good, human-engineered standard operating procedures (SOPs).

In the cannabis growing process, there are different types of mistakes that, when analyzed, all can be addressed in the same manner. For example, some common errors that we see are either overwatering or nutrient burn, which can occur when the plant is overfed. The same is true in the opposite scenario; underfeeding or under watering lead to problems as well. If your process is not automated, the reason for these failures was most likely human error. Now, why did the person make that mistake? Was there a procedure in place? Was the employee trained? Is there a specific process with steps, sub-steps, quantities and measures? Were tools available to be able to do the task correctly? There is so much that can be done about these questions if we had clear, well-written and simple, but specific instructions. The benefits greatly outweigh the effort required.

Also, besides providing step-by-step instructions to avoid commission errors (to perform incorrectly as opposed to omit some step), there are other types of errors that can be avoided with SOPs.

Decision making like detecting nutrient deficiencies can lead to human error.

Decision-making is another reason why we sometimes get different results than the ones expected. If during your process there are critical, knowledge-based decisions, workers need to be able to get all the information to detect as well as correct situations. Some decisions are, for example, when (detection) and how (steps) should I remove bud rot? Is there a critical step in the process (caution) to avoid other plants from becoming affected? Any information on the what, how, when, where and why reduces the likelihood of a decision error, later described as obvious.

When we face manufacturing challenges like nutrient deficiency in a particular stage, mold, fungus, gnats or even pollination of females, we want to do whatever we can to prevent it from happening again. So consider that from avoiding to detecting errors, procedures are a critical factor when improving human performance.

Here are some guidelines when writing procedures to prevent human error.

  1. Use them. Enforce the use of procedures at all times. As humans, we overestimate our abilities and tend to see procedures as an affront to our skills.
  2. Make sure it is a helpful procedure and users are involved in the process. People that participate in writing rules are more likely to follow them.
  3. Make sure they are available for their use.
  4. All critical activities should have a procedure.
  5. The procedure needs to be clear, have a good format, clear graphics, appropriate level of detail and specific presentation of limits.
  6. Make sure that facts, sequence and other requirements are correct and all possible conditions are considered e.g. “what if analysis”.

Human error won’t be eradicated unless we are able to really identify what is causing humans to err. If eliminating or “fixing” the actual individual eliminates or potentially reduces the probabilities of making that mistake again, then addressing the employee would be effective. But if there is a chance that the next in line will be able to make the same mistakes, consider evaluating human factors and not the human. Take a closer look and your process, system and ultimately your procedures.

Green Man Cannabis Recalls Due to Pesticide Residue Detection

By Aaron G. Biros
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Denver-based Green Man Cannabis last week voluntarily recalled batches of cannabis sold to both medical patients and recreational consumers. The recall comes after the discovery of off-label pesticides during inspections in both dry-flower cannabis and infused products.

Photo: Sheila Sund, Flickr
Photo: Sheila Sund, Flickr

According to the Denver Department of Environmental Health (DEH), the products have labels that list an OPC License number of 403-00738, 403-00361, or 403R-00201. The cannabis in question is not a specific batch, rather, “All plant material and derived products originating from these cultivation facilities are subject to the recall.” The DEH’s statement includes contact information for the company (email: recall@greenmancannabis.com) and the DEH Public Health Inspections Division (email: phicomments@denvergov.org or 720-913-1311).

The DEH statement does not mention which pesticides were detected or the levels at which they were detected. Christian Hagaseth, founder of Green Man Cannabis, says the chemical detected was Myclobutanil. “We had used Eagle 20 in the past, [the pesticide that contains Myclobutanil] but we stopped using it as soon as it was banned,” says Hagaseth. “The DEH found the residues in the growing environment so we immediately performed a voluntary recall.” Green Man has three cultivation facilities, one of which they suspect is contaminated from pesticides sprayed a few years ago.

Christian Hageseth, founder of Green Man Cannabis
Christian Hageseth, founder of Green Man Cannabis

As far as corrective actions being taken, Hagaseth says they are doing a thorough cleaning and sanitation in two of their grows and a complete remediation plan in the suspected contaminated grow. “This was a good learning experience- the key takeaway for us is we need to clean these environments more consistently,” says Hagaseth. “I am grateful that the system is working; public health and environmental safety are being looked after here.” Hagaseth says the facility in question was operating almost without interruption since 2009, but they adjusted and learned to implement preventative actions following the recall.

The DEH says there have been zero reports of illness related to the recall. “The possible health impact of consuming marijuana products with unapproved pesticide residues is unknown,” the statement reads. “Short and long-term health impacts may exist depending on the specific product, duration, frequency, level of exposure and route of exposure.” The DEH advises consumers that may be concerned to reach out to their physician.

The DEH performs routine inspections of cannabis infused product manufacturers and retail locations in Denver, as well as investigating complaints. “I am sorry that it happened to us, but I am happy the system is working and we are more than happy to comply,” says Hagaseth.