Cause & Effect Diagrams for Quality Management

The Cause & Effect Diagram, aka Fishbone diagram, Ishiwaka diagram or Why Why Tool is a tool most commonly used in Quality Management and Risk Management. Its design merges brainstorming (often based on incident reports) and mind mapping techniques to help mangers to identify all possible root causes and potential risks. The most common applications include identiying the following.

• Potential causes of problems in new product design
• Quality defects and their causes that can be prevented
• Symptoms of the cause

How to use the Cause & Effect Diagram

The "head" of the fish's skeleton represents the problem or "effect" as described in a risk register usually appears on the right. The "bones" extend to the left of the head to display various causes. However, to better organize the exercise, each rib denotes a category or classification of these causes. Smaller bones can therefore branch out into causes and even sub-causes. The branching depends on the levels required under each classification.

The "ribs" or classifications can and should vary according to your industry and or functional objectives. For instance, manufacturers often use the '6Ms', which are a group of "ribs" or classifications that have been become a manufacturers' standard after the automobile company Toyota popularized it. 

Brainstorm. Ideally, seek different perspectives from persons in different functional areas. Also inspect the site for hazards. Keep in mind that, while risks relate to the 'effect' end of situations, 'hazards' relate to the 'cause' end. Consequently, you can improve this root cause analysis by appropriately matching hazards (like a lion) with corresponding risks (like injury or death of human beings).

6Ms

1. Man

2. Machine

3. Material

4. Method

5. Measurement

6. Mother Nature/ Milieu (Environment)

7. Management (used by some managers) 

8. Maintenance (used by some managers)

Example using Toyota's 6Ms. (Illustration video also included below)

1. MAN. Includes: skills, job assignment. (HRM; SCM; target/non-target). 

• A risk may involve not using the best practices for interviewing and selecting appropriate candidates; failing to properly onboard candidates, etc.

2. MACHINE. Includes: tools; equipment, condition of ~, etc. 

3. MATERIAL. Includes. production inputs 

4. METHOD: Includes efficiency, complication, existence of procedure. 

5. MOTHER NATURE & MILIEU (ie social environment). Includes weather conditions, culture.

6. MEASUREMENT. Includes variable frequency or levels like temperature, time, quality, adequacy, number of people, etc.  NB. This is sometimes excluded for redundancy if there is a preference to include measurement in the other categories.

Symptom(s): Aids to identifying cause(s).

Other Common Classifications 

1. Marketing professionals commonly use the following 7Ps.

1. Product 

2. Price

3. Place

4. Promotion

5. People

6. Positioning

7. Packaging

 

Service industry professionals commonly use the Service 5Ss:

1. Surroundings

2. Suppliers

3. Systems

4. Skills

5. Safety

 

CONTENT RELATED TO CAUSE & EFFECT DIAGRAMS FOR QUALITY MANAGEMENT & RISK MANAGEMENT

• Hazards 101
• Illustration of the manufacturer's 6Ms fishbone diagram. 

                 

• Simplified illustration of the fishbone diagram method for a resolving a problem (inadequate handwashing) 
• More complex illustration of resolving the problem of patient falls in a Nevada Division of Public and Behavioral Health facility (video starts from relevant section @17:31)
• Incident reports can help to find causes when completing the fishbone diagram.  
• Product Liability Insurance is a planned risk response that proactively transfers risk to a third party. Read about it to find ways to improve production and risk management plan accordingly.
• Risk management is an essential part of a Research & Development (R&D) project.

Incident Reports for Risk Management

What is an incident report & why is it necessary?

An incident report is a formal record of the facts related to an accident, near miss or injury. This document is an integral part of risk management, (particularly the management's response and monitoring & control stages of risk management). Its primary purpose is root cause analysis (aka fishbone diagram analysis), ie to discover the circumstances that led to the occurence of a risk so as to prevent future incidents.  

Incident reporting is NOT intended for comparisons. For instance, if different reporting units are compared for safety based on incident reporting volume, a unit with more reports of adverse events may be incorrectly marked down when, in reality, the converse may be true. For instance, that unit may simply be more vigilant, have a better culture regarding safety-consciousness and preparedness for submitting reports. That unit may well be conducting more double checks than its counterparts.

Incident reporting is NOT intended for measuring performance (like safety, brand awareness, etc) like number of medication errors issued by a hospital to determine that hospital's safety. As seen from the earlier example that highlighted why a high volume of incident reports is not necessarily the sign of bad performance, incident reports are much better for identifying risks and root cause analysis. Besides, statistics show that just over 5% of all adverse events in health care are reported at all. In other words, units with more reports of adverse events are possibly more worthy of one's trust.  

Incident reporting is NOT intended for tracking the changes over time of reporting. This is due to reporting bias. For instance, the healthcare industry sometimes saw very significant increases in reports after its communities implemented improved reporting systems. As the earlier discussions already illustrated, a higher number of reports does not necessarily denote higher risk levels.

The contents of an incident report

As recommended by SafeSite Solutions, EVERY incident report should have the following as a minimum.

• Type of incident 
• Events with an undesirable outcome: injury, property damage or theft
• Events with no undesirable outcome, this time (because a hazard was exposed): near miss
• Location of the incident (and or any other context-specific detail that might determine liability. While 'location' is useful for OSHA-type reporting for protecting workers in the workplace, conditions in which products and services are used may require other customized fields.)
• temperature (if it is a factor that ensures and determines safe use, like temperature logs of meat storage facility where meat went bad and caused illness) 
• Date of incident
• Time of incident
• Name of an affected individual * (Also include qualifying details related to individual's membership in a population, segment, etc of at-risk individuals)
• Jane Donut, aged 5 (if age is important to segment definition) 
• A narrative description of the incident, including the sequence of events, results of the incident and response.* (Considering the definition of 'risk' where a deviation occurs from the expectation and the concept of an 'inciting event' that changes the normal business as usual course of any story that would have been otherwise too uneventful to tell, describe the event from which the deviation occurred.) 
• Example: Hazel's X-blade scissors fell from her desk onto her lap (the 'inciting event' described plainly and objectively) while she was stitching an item A25 (the normal story that would have been too uneventful to tell otherwise). Suspecting a deep lap wound, her boss (Jackie Mason) called 911 (business representative's response). Hazel reported feeling a sudden and overwhelming feeling of exhaustion that made her "nod" for a second. (The version of the injured party). 
• Description of Injuries, if any & severity in terms of the business context. 
• Example: broken right index finger. Injury will require at least x weeks for recovery, resulting in downtime in the typing role for that period.
• Example: Bruised forehead. Jim returned to work within 5 minutes. 
• Treatments required, if any
• Witness name(s)
• Witness statements
• Other workers involved
• Video and/or 360-degree photographs of the scene

Add contextually relevant items like the following.

• Whether or not proper personal protective equipment (PPE) was being used
• The root cause(s) of the incident
• Associated hazards raised and resolved following the event
• The affected individual’s version of the events
• Actions taken by concerned individuals after the incident

Key Considerations

*Create a separate report for each individual even if more than one person is injured. While it is acceptable to duplicate general details across reports of this nature, each report will need details specific to each individual, like the event from their point of view or medical records.

*Include quantifiable measurements where possible. Example: The ladder capacity is 250 lbs and the victim was hoisting 300 lbs.

Review good samples of incident reports on SafeSite Solution's website.

Best Practices for Implementing an Incident Report System

• Design the reporting system to provide value to risk management. The system should be able to generate in-depth analysis and result in strong interventions to reduce risk. A very well designed system has several versions of the incident report. For instance, one version is specifically designed for near misses, falls, behavior incidents, specific types of injury, etc. 
• Encourage all persons to report all incidents, however small, even if "nothing happened!" (aka a near miss). 
• Make the process meaningful to the reporter (as a means to incentivize their best use). Allow the process to give reporters a sense of empowerment. Really stress appreciation for the reports. Follow up on reports to show that the reporter's time was not wasted.
• For instance, allow incident reporters to recognize that they are contributing to the improvement of the product or service they sell.
• Foster a no-blame approach to reporting. Where that is difficult, consider making the reporting process anonymous.
• Make the process as simple and convenient as possible. 
• Some templates offer electronic contact forms. 
• Electronic forms have become popular. The OSHA offers Excel spreadsheets with fields that can be filled in over time.
• Consider your reporters. If they are the type of people that will be turned off of completing incident forms, consider another medium they are more likely to use, perhaps a telephone number they call so that someone else completes the form. 
• Define the event as well as possible.
• Injury, near miss, etc  
• Define the at-risk population as well as possible. Example: A market has segments like children below 5 that are at risk of injury for products with certain features like harsh chemicals. 
• Consistently monitor the at-risk population, especially if it exhibits risk-inducing behavior.
• Encourage persons writing reports to be objective and to avoid blame games. Mangement's response should show gratitude for the chance to implement measures to prevent similar events in the future.

Integrate Incident Reports into your Risk Management

• Identify and assess the hazard(s) 
• Identify the risk(s) whose occurrance it is a possible or even probable cause (using root cause analysis example using a fishbone diagrams)
• Considering the level of exposure of the hazard and the consequent probability of the risk, (re)assess the risk rank.
• Adopt the appropriate risk response.

CONTENT RELATED TO INCIDENT REPORTS FOR RISK MANAGEMENT

• Risk management 101
• Hazards 101
• Other types of risk management risk documents include checklists.
• SafeSite allows you to signup for a free or paid account. They offer many resources that promote worksite safety like incident report examples, templates, checklists, workflows, inspections and so on.
• Free downloadable and customizable templates (SafeSite)
• A near miss aka close call, near accident, accident precursor or injury-free event is an event that could have been an accident had things played out differently. It occurs because of exposure to a hazard like a nut-flavored snack, a hazard (for those with nut allergies) is unlabeled and provided as free samples to the public. Thinking the item is nut-free, the public is exposed to the hazard and persons prone to anaphylaxis begin to sample it, thereby running the risk of anaphylaxis. A near miss report should lead to hazard resolution and preventative measures. In this example, the hazard resolution involves labeling the snacks or removing them from the reach of the public. However, if the event isn’t reported or addressed, a serious injury could easily result, possibly only hours later from the same or similar circumstances. Other examples include nearly getting Covid-19 by wearing inadequate protective personal equipment (PPE).

   

Notes:

Occupational Safety and Health Administration (OSHA). With the Occupational Safety and Health Act of 1970, the US Congress created the Occupational Safety and Health Administration (OSHA) to ensure safe and healthful working conditions by setting and enforcing standards and by providing training, outreach, education and assistance.

Hazards in Risk Management 101

This post extends my earlier discussion on risk management, specifically as it relates to hazards, aka dangers.

A hazard is anything, a situation or object that has the potential to cause harm, damage or adverse effects (to people, the environment, assets or reputation). While risks may represent negative or positive outcomes, hazards relate only to negative outcomes. Consequently, they deserve special attention when there is a preference for a higher-than-usual level of risk aversion as with medicine, public meeting places, workplaces and other area that can affect human health and life.

For the most part, a hazard is always inherently dangerous. However, an interesting characteristic of a hazard is how its danger can remain latent under certain circumstances. Specifically, a hazard requires 'exposure', ie some behavior or condition to activate its potential for causing the risk to occur.  In other words, IF handled appropriately, hazards are acceptable like a menace contained within pandora's box as they pose only possible (NOT probable) danger. The probability of an undesirable outcome is 'minor & remote'. Conversely, if a hazard is not handled in the prescribed way, the risk rating changes. the undesirable outcome is 'probable & imminent'.

Example(s)

• Negative Risk: Chemical burn (effect)
• Hazard: dry sodium hydroxide (possible cause)
• Exposure: Adding water to sodium hydroxide.
• Control: Avoid the risk by never adding water or moisture to the sodium hydroxide.
• Control: Use Personal protective equipment like gloves, long sleeves, long pants when pouring the water

• Negative Risk: Death (effect)
• Hazard: lion (possible cause)
• Exposure: Breached barriers in a zoo.
• Control: Barricade the lion with moats or cages.
• Control: Barricade humans within their cars.

• Negative Risk: Skin irritation (effect)
• Hazard: perfumes (possible cause)
• Exposure: Using fragrance oils.
• Control: Substitution with safer, naturally extracted aromatic alternatives.

Identifying Hazards

Since a hazard is on the 'cause' end of a risk, it is helpful in the root cause analysis techniques like analysis by Fishbone diagram. As can be appreciated from the examples above, its level of 'exposure' or 'being controlled' is useful in the risk risk assessment process. Specifically, if a hazard is controlled, the probability score that the risk will occur is largely minimized. Conversely, hazards that are poorly controlled and to which there is exposure raise the probability score of the risk occurring considerably.

Although hazards are often identified within the context of predetermined risks (Fishbone diagram), hazards are also identified by site, task, tools, machine, substances, specific types of human interaction, etc. It may therefore also be useful to consider how hazards are formally categorized ... for the sake of checklisting during an inspection. Formal categorizations include WHMIS 2015. As with anything else, a highly customized approach is suggested for whatever your area. For instance, if you are concerned specifically with the staff selection process, you may use your checklist that may include core values, hard skills, soft skills and so on. 

Here are some other examples of hazard categorizations.  

• Physical. Example(s): Tangled wires in a walkway, slippery floors, loud noise, inappropriately used machinery, flammable materials, poor lighting, 
• Chemical. Example(s): leaking gas, dust clouds, noxious fumes, strong acidic liquids, strong alkaline liquids. 
• "Physical health hazards" may include: highly toxic agents; carcinogens; corrosives; sensitizers; irritants; hepatotoxins; nephrotoxins; neurotoxins; agents that damage the lungs, skin, eyes or mucous membranes    
• Ergonoomic. Example(s): Poor design of workspace, poor design of equipment, 
• Radiation. Example(s): ultraviolet rays, x-rays, microwaves, infra-red
• Psychological. Example(s): work overload, harasssment, discrimination, sabotage, threat of danger, stress   
• Biological. Example(s): infection (by bacteria, virus) through cuts, contact with contaminated objects 

Hazard Inspection Best Practices

Dealing with Hazards

As mentioned previously, hazards may exist without ever posing a real threat. After all and as seen above, they are inherently different to risks. Furthermore, they are causal while risks are the effects or the (negative) event. When tending to an incident, regardless of whether that event involved a negative event (like injury or other damage or loss) or a near miss which did not result in a negative event, this time, the cause or hazard should be identified.

• Ask witnesses and affected persons for their supposition of the hazard. Different interpretations of situation may arise at multiple causes or hazards. Assess all of them.
• Figure how to control the hazard. This varies across industries and will need research within the field. 
• Example(s): Compliance with Globally Harmonized System (GHS) of Classification and Labelling of Chemicals has a short list of 6 categories for chemical consumer products (flammability, acute toxicity, skin corrosion / irritations, serious eye ddamage / irritation, skin / dermal sensitixation, acute & chronic aquatic hazards) along with required label information (like product identifiers, supplier identification, signal words, pictograms, statements and precautionary statements).

• Assign tasks for controling the risk
• Reviews of performance of those tasks
• Routinely review whether the hazards has a different rate of potentiality.

CONTENT RELATED TO HAZARDS MANAGEMENT

• Risk management 101
• Incident reports
• Just to recap Risk VS Hazard

    

    

Product Liability Insurance for Small Manufacturers

Your customers and other consumers have a legal right to expect that your product is safe which means that it will not cause them harm. Consequently, they can sue you, the manufacturer or seller when they suffer injury. This type of legal action falls under tort law, which is interested in awarding compensation aka 'damages' to persons who have suffered as a consequence of wrongdoing by another. To be clear, the complaint may relate to harm suffered by any end user. In that case, the buyer of a car may sue on the basis of harm caused to his or her child as a passenger (even if the child was not a driver or the paying customer).

This type of liability can be established based on the following two conditions.

1. the manufacturer operates a business. (A manufacturer's liability exists only on the basis of proof of harm, while a hobbyist's liability requires other forms of proof, like unsafe production conditions)

2.   the product has not been changed before reaching the consumer.

Additionally, complaints must be based on at least one of the following three 'product defects', as contrasted against the standard of safe competing products.

1. Design Defect. This would apply if, even before making the product, some planned element has an inherent flaw that can cause harm. Every unit made is therefore potentially harmful. Consequently, multiple parties (not just the odd one or two) are likely affected.
2. Manufacturing Defect. Manufacturing defects usually affect only one or a few units of the product, often because of one-off or temporary challenges like errors made by a new employee that has been poorly trained or if a natural disaster causes production line errors. 
3. Warning (aka Marketing) Defect. This defect refers to non-disclosure of and or inadequate instructions for avoiding foreseeable harm. This applies when risks are inherently potential during use or when there are limits to which protection should be expected. Examples: hand sanitizer that is responsibly sold should warn consumers of the hazards of combustion with the use of the globally recognized symbol #3 (for flammable products); matching tyres to different weights and types of motor vehicle. Just to clarify however, rest assured that not all injury gives consumers legal right as in cases in which consumers sustain injury while inappropriately using your product or modify your product in a way that contributed to their injury. Furthermore, injury can be claimed for only physical products. Consequently, electronic products that render undesirable results do not count. 

DO's

• Get product liability insurance coverage. Even if you design the best possible product, consider that the risks are too great if members of the public with rare, unforeseen circumstances can be adversely affected by your product. While many of your colleagues will likely confess to not having insurance coverage as claims are rare to none, insurance provides peace of mind against that one-in-a-thousand-cases complaint that costs you your entire business and life savings. To be clear, you should also consider insurance once persons other than you use your soap. This even includes if you make soap only for the sake of giving them away soap free of cost as Christmas gifts. After all, even someone suffering from an allergy against ingredient X can end up with steep medical bills they find unbearable as their justification to demand your financial assistance. 
• Consider specific ways in which your product type can potentially harm consumers. This will be your guide for taking preventive action. For instance, if you sell cosmetic products you make, like most other such serious (cottage industry) manufacters, you may feel complacent because you likely already ensured that your formulations are safe for your target market, ie your product design is safe. Do not stop there. Tackle the other 2 types of product defect. For instance, consider all the ways you can improve your communication to manage the risk of 'warning defects' on product pages and labels. If there are known allergens, they should be stated. Do you use utensils for other formulations that contains allergens like nuts, gluten and so on? Do not hide ingredients, especially those with the potential to cause allergic reactions in some people. Have you even noticed YouTube videos with very technical information suggesting that the information is only for educational purposes and that the consumer of the information should seek professional advice? Such producers are protecting themselves. Similarly, even product manufactures often provide infomercials in a similar way. 
• For no additional cost to you or other key stakeholders acting on your behalf like authorized retailers, you can offer to name their business as an 'Additional Insured' on your General and Product Liability policy. It relieves the other parties of the burden of product liability claims involving your product. Ideal for B2B customer relationship building!
• If possible / applicable to your work, transfer risk to suppliers. Needless to say, whenever possible, do business with those suppliers that can name your business as an 'additional insured' on their 'ACORD Certificate of Liability Insurance' aka Certificate of Insurance (COI). This offers protection in the event that their product is responsible for a product liability claim. However, this is rare in manufacturing because most manufacturers alter their supplier's product. However, this may work if your process does not alter your supplier's product. If possible, include a 'Hold Harmless' clause in your contract that can absolve you of legal liability for any injuries or damage suffered by your counterparty. Hold harmless clauses are also rare and rightfully approached with much caution.
• Find options for insurance coverage that work with small manufacturers, particularly if they specialize in your type of industry. Here are some examples.
• RLI provides coverage for home-based manufacturers with craft-oriented categories that include bath and body that earn relatively low gross profits. For instance, if your business earns under roughly USD 8,000 yearly, you may be eligbile for coverage up to roughly USD 1 million and need to pay premiums at roughly USD 300 yearly. RLI is therefore ideal for new, small-scale manufacturers. However, your physical manufacturing primary home base must be the mainland US, Canada or Puerto Rico.
• Industry trade groups aka trade associations provide the advantage of offering members highly customized insurance options.
• The Handcrafted Soap & Cosmetic Guild /  HSCG is a highly specialized trade association that can provide from the most basic formulation instruction to the more advanced support that in addition to insurance, includes discounted rates for operational costs (like postage & supplies), business advertising and supports legislative advocacy. In addition to different tiered costs of membership, insurance costs roughly  USD 275 to 380 yearly, with the second option providing property coverage. As per usual for US-based trade associations, membership is restricted to US-based persons. However, there are free resources that include website-based classes, YouTube videos and other useful soap business documentation. 
• Although Indie Business Network aka IBN exists for general life and business planning, it offers insurance as an optional complementary service to members based in North America and selling in North America or internationally. Despite being a complementary service, there are even specialized areas like food & beverage, handcrafted soap & cosmetics (& jewelry), infused products and so on. Outside of the cost of the pre-requisite IBN membership of USD 195/year, the insurance policy typically costs USD 275 to 330 / year. If you are new to this network and need more insight or consideration time, sample some of its free resources like podcasts that often feature interviews of fellow members. Otherwise, the school offers short courses for a relatively small fee.
• Other option(s): The HandMadeInsurance company /  https://www.handmadeinsurance.com/

• When seeking a policy, consider the following. Some brands provide relevant 'fine print' information in very digestible lists like 'what is covered', 'what is NOT covered', 'schedule of costs' and so on (like IBN regarding insurance coverage for handcrafted soap and cosmetics). 
• Whenever possible, liability insurance should cover legal fees. After all, legals fees are often enough to severely hurt a business.
• The policy should naturally cover the damages / cost of the judgment, thereby protecting your (personal) assets up to the policy limits.

CONTENT RELATED TO PRODUCT LIABILITY

• Figuring out insurance is necessary, even while you prepare to launch your new product.
• See how to create a risk management plan. Risk management can eliminate or at least mitigate the tedium of facing product liability claims at all.
• Avoid 'warning' / 'marketing' product defects. Know about hazards management.
• Ensure your product labels avoid 'warning defect'. Learn about multilingual product labels.
• Another way of protecting your personal assets is by separating the operations and assets of your business and personal assets. One key way of doing this is by registering the business as a limited liability corporation (LLC).
• Do not be surprised if farmers' markets ask to be named as 'additional insureds' on your insurance policy.
• Just to be clear; do not confuse product liability insurance with other forms. For instance, it will not cover employees. If you wish to have coverage for employees, you will need a different policy outside of product liability. Recognize the distinction between you and anyone working on your behalf and the public that comes into contact with your business and or product. Consequently, if a customer walked through your establishment or that of an 'additional insured' retailer and had an accident like tripping over boxes on the floor, your insurance might also cover the case, even though the accident does not directly relate to the final intended use of product.