IATF 16949:2016 Product safety

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Product Safety has gained significant importance within the global automotive industry during the last few years. The numbers of re-calls were 4-times as high in 2016 as they were in 2006. The impact of those re-calls on manufacturing companies is devastating. Newspapers regularly report about major recalls in the automotive sector, in which even small product defects led to a global disaster. During a re-call, companies not only have to face direct costs but also damages to the brand image. Furthermore, there are severe penal risks for acting negligently or on intentional purpose.  Observing the increased numbers of re-calls, one might think that products became a lot more unsafe in recent years. The actual cause can rather be found in the occurrence of more strict legal requirements, increasingly stricter authority- activities, and the validity of different legal requirements in different countries. Accordingly, organizations have to follow more different and more strict external requirements, while at the same time authorities are way more active and globally interlinked than in the past. In parallel to this development, global automotive manufactures are urged to handle a constantly increasing degree of complexity. This is mainly caused by an increased variety of parts that are being produced and handled, the increasing amount and difficulties of internal and external interfaces in a global production network, and the increased manufacturing complexity. Although organizations are facing this higher complexity and stricter legal requirements, they still have to fulfill customer‘s expectations towards safety and quality. Customers do not accept a lack of quality and neither they would accept any unsafe products at any time, that’s why many companies are investing in marketing and marketing research to know exactly what the clients want, and some even will Buy Instagram followers to have a bigger client database. A recent survey showed, that safety and quality are rated as the two most relevant factors for customers during their vehicle selection process in today’s time as well as in a 25-year forecast. Safety and quality represent a key to market success within the global automotive industry. Due to the severe risks of product liability and the high degree of complexity, organizations need to be aware of, which of their processes in the value creation chain have an impact on the safety of their products. With this knowledge, they are able to install appropriate measures that ensure the conformity of processes and products and thereby contribute to improved Product safety and minimized liability risks.

Definition of product Safety

IATF defines Product Safety as ” standards relating to the design and manufacturing of products to ensure they do not represent harm or hazards to customers“. Product Safety represents a subset of quality. ISO 9000 defines Quality as the degree to which a set of inherent characteristics fulfills the requirements. The mentioned characteristics can thereby be considered as many different and numerous aspects. This includes for instance things like appearance or sustainability. Eventually, it is always the customer that judges the quality of a product or service. The special thing with the quality-characteristic safety is that no customer would ever accept any compromises and therefore always expects its complete fulfillment. Product safety can be termed as “Reliability in regard to safety-relevant defects”. Resulting in the logic that safety-relevant defects furthermore are considered as all defects that may result in a danger to humans participating in the traffic. Besides the organizational framework, the activities within the product creation process have a direct impact on the safety of the product.

Product safety is a term used to describe policies designed to protect people from risks associated with consumer products they buy and use every day. Product safety is the ability of a product to be safe for intended use, as determined when evaluated against a set of established rules. The legislation sets out clear test and documentary requirements that manufacturers and distributors must follow to demonstrate that their products meet defined safety criteria and are safe for the intended use. Evidence that the prescribed legislation has been conformed with can be demanded by the enforcement authorities within strict time frames. All consumer products must be safe and meet consumer guarantees under the product safety laws. There should be some safety standards. These standards are designed to ensure the safety of products, activities or processes, etc. The Indian consumer has the ‘right to be protected against marketing of goods and services which are hazardous to life and property (Consumer Protection Act 1986). There are many rules & regulations concerning consumer product safety in India. There are general like the Sale of Goods Act, 1930, Consumer Protection Act, 1986, Bureau of Indian Standards and Import Policy 2012 for the safety of the consumer products. To implement the rules there are mechanisms enforced by regulatory bodies. These mechanisms are operated through the Bureau of Indian Standards Act.

IATF 16949:2016 4.4.1.2 Product safety

It is required that the organization must have documented processes for the management of product-safety-related products and manufacturing processes. The documented process must include if applicable identification by the organization of statutory and regulatory product safety requirements. The documented process must include if applicable customer notification of requirements in the identification of statutory and regulatory product – safety requirements. The documented process must include if applicable special approvals for design FMEA. The documented process must include if applicable identification of product safety-related characteristics. The documented process must include if applicable identification and controls of safety-related characteristics of the product and at the point of manufacture. The documented process must include if applicable special approval of control plans and process FMEAs. The documented process must include if applicable reaction plans. It must be defined responsibilities, the definition of the escalation process, and the flow of information, including top management, and customer notification. The documented process must include training identified by the organization or customer or personnel involved in product—safety-related products and associated manufacturing processes. The documented process must include changes of product or process shall be approved prior to implementation including evaluation of potential effects on product safety from the process and product changes. The documented process must include the transfer of requirements with regard to product safety throughout the supply chain, including customer-designated sources. It must include product traceability by manufactured lot (at a minimum) throughout the supply chain. It must also include The documented process must include if applicable lessons learned for new product introduction.
NOTE: Special approval is an additional approval by the function (typically the customer) that is responsible to approve such documents with safety—related content.

Explanation:

The new clause titled Product Safety requires a documented process for the management of product safety. This clause defines 13 normative elements that must be included in the documented product safety process. These 13 requirements include identification of product safety characteristics, the inclusion of safety characteristics with approvals in design and process FMEAs, control of safety characteristics at the point of the manufacturer with documentation in control plans with specific reaction plans, and defined responsibilities for product safety management including the definition of an escalation process and flow of information, including top management, and customer notification. Additionally, that personnel involved in product safety-related processes will have specific training. The new standard also requires the identification and review of safety targets as part of the product design inputs. Work instructions are required to include rules for operator safety. Product identification and traceability has been expanded to ensure the clear start and stop points for the product received by the customer or in the field that may contain quality and/or safety-related nonconformities with the same requirements extended to externally provided products with safety/regulatory characteristics. The IATF stated this requirement was strengthened to support industry lessons learned related to field issues. Control of reworked products is a new requirement in the rev 2016 standard. Within this new clause, the organization is required to obtain approval from the customer prior to commencing rework of any safety and regulatory characteristics related to the product. Disposition of Nonconforming products is another scope expansion of the new standard requiring products not meeting safety and regulatory requirements to be scrapped and rendered unusable prior to disposal. Lastly, the management review inputs are required to include a review of actual field failures and their impact on safety or the environment. The justification given by the IATF for the expansion of these requirements was to address current and emerging issues the automotive industry is facing related to product and process safety.  While some of these changes are incorporating present customer-specific requirements, others are clearly intended to drive increased awareness of safety-related issues throughout the automotive supply chain. The following 13 elements need to be included in the documented product safety process.

• Statutory and regulatory requirements for product safety – the organization needs to identify all legal and other requirements related to product safety. This can include the methods of identification and review of this information.
• Customer requirements regarding product safety – usually, this information is clearly stated by the customer, but there are always some requirements that are implied and are part of the Statutory and regulatory requirements for product safety.
• Safety-related characteristics of the product – considering the lifecycle of the product and how it is used, the organization needs to identify those characteristics that are relevant for product safety.
• Product safety-related controls at the point of manufacture – the organization needs to establish appropriate process controls to ensure that the product meets safety requirements.
• Special approval of process FMEA and control plans – special approval is additional approval by the function (usually the customer) that is responsible for approving such documents with safety-related content.
• Reaction plans – these usually include containment of the product and 100% inspection if necessary.
• Responsibilities, including the escalation plan and flow of information to the top management and the customer.
• Training for the personnel involved in the product safety and manufacturing process (training requirements can come from the organization itself or from the customer).
• Approval of the changes in the product or process, including evaluation of the effects of the changes on the product safety.
• Transfer of the product safety requirements throughout the supply chain, including customer-designated sources.
• The new standard also requires the identification and review of safety targets as part of the product design inputs.
• Product identification and traceability have been expanded to ensure the clear start and stop points for the product received by the customer, or in the field, that may contain quality- and/or safety-related nonconformities, with the same requirements extended to externally provided products with safety/regulatory characteristics. The IATF stated that this requirement was strengthened to support industry lessons learned related to field issues.
• Control of reworked products is a new requirement in the 2016 revision of the standard. Within this new clause, the organization is required to obtain approval from the customer prior to commencing rework of any safety and regulatory characteristics related to the product.
• Disposition of non-conforming products is another scope expansion of the new standard, requiring products not meeting safety and regulatory requirements to be scrapped and rendered unusable prior to disposal.
• Lastly, the management review inputs are required to include a review of actual field failures and their impact on safety or the environment.

Ten Principles of Safety Management

1. Establish and observe a written corporate safety policy.
2. Create an independent safety review process.
3. Identify and evaluate the severity and foreseeability of product hazards.
4. Conduct a design review assessing the risk of injury by considering the hazards, the environment, and foreseeable use.
5. First attempt to eliminate hazards. If not possible, then reduce the opportunity for injury by guarding against the hazards.
6. Warn users of product dangers and motivate them to avoid injury.
7. Promote only the safe use of a product.
8. Maintain safety-related records during the useful life of the product.
9. Continuously monitor the safety performance of the product in the hands of users.
10. Promptly notify product users and institute recall procedures where necessary to substantially reduce or eliminate injury.

1. Establish and observe a written corporate safety policy.

A written corporate safety policy is the ultimate responsibility of top management. The document is designed to detail executive commitment, both statutory and voluntary, to the concept of system safety; a before-the-fact management system designed to ensure the production and distribution of reasonably safe products. Oral direction such as “safety is everyone’s responsibility” provides inadequate instructions to the organization. The policy must describe management commitment to clear identification of the responsible corporate units for the tasks of hazard identification, risk assessment, and injury control. The primary goal of a written safety policy is the creation of a management system to substantially reduce or eliminating injury to consumers.

2. Create an independent safety review process.

The independence of the safety function within the management structure is crucial to successful analysis of potential product dangers. The corporate Safety director is an advisory role, with the authority to interact with technical functions such as product design, engineering, human factors, communications, and legal. The safety manager must be able to order safety-related analyses by the various technical divisions and have the authority to integrate the results for presentation directly to top management for decisions on injury control. It is critical that the safety management office be independent of production and distribution. Giving a production manager primary responsibility for safety will divide his or her loyalties and compromise injury control before management review. The safety director often will preside over a safety review board is compromised of members from the technical divisions.

3. Identify and evaluate the severity and foreseeability of product hazards.

A hazard is the inherent capability of a product to do harm. It is most often the result of an energy transfer or release, with such transfer creating an impact on the product user. The appropriate analysis must include a focus on whether the hazard is latent to the user while foreseeable to the producer and the impact on certain vulnerable population groups. The vast majority of car drivers do not understand that Petrol and LPG leakage can create dangerous conditions when the safety valve fails to operate. A little spark can create a catastrophic explosion. Children cannot recognize strangulation hazards in and around Safety belts. Manufacturers and distributors must proceed with extra caution where the hazard is not immediately apparent to the user.

4. Conduct a design review assessing the risk of injury by considering the hazards, the environment, and foreseeable use.

Risk of injury is the opportunity for a specific set of conditions to create harm: Under what circumstances can the user be injured? An examination of the identified hazards, the environment in which it is intended to be used and foreseeable use and misuse of the product by the user population must be considered. An all-terrain vehicle, or ATV, can be an inherently unstable 300-pound machine that can throw a rider. Crushing injuries can occur in addition to the impact by overturning. ATVs are intended to be used in uncontrolled, wilderness environments, such as mountainous paths, sand dunes, and over obstacles. By creating a recreational, sometimes uninhibited setting, ATV riders can foreseeable use the product by going fast, racing with friends, or even by partaking in alcoholic beverages. While not always appropriate behavior to a safety analyst, it is foreseeable that these situations will occur and must be considered to effect reasonable safeguards to prevent injury.

5. First attempt to eliminate hazards. If not possible, then reduce the opportunity for injury by guarding against the hazards.

By eliminating a specific hazard, certain injuries cannot occur. Some automotive workshops have pits to enable work to be done. The vehicle is driven over the pit, and the mechanic works from beneath. Because carbon monoxide (from the vehicle exhaust) is heavier than air, the fumes may build up in the ‘confined space’ under the vehicle. These fumes need not be only from the vehicle being worked on: if other engines are running nearby, there is still a significant risk of exhaust emissions collecting in the pit. Using a hoist eliminates the danger. But in other cases, this is often not possible. Gasoline creates toxic and explosive fumes. It is not possible to eliminate them without destroying their usefulness. Gasoline can, however, be stored in an appropriate canister to prevent the fumes from leaking into a water heater closet in the garage causing an explosion and severe burn injuries. A power mower employs a steel blade rotating at over 200 mph, but lawnmowers can incorporate devices to shut down the blade when the operator releases the controls and can shield user access to the rotating blades.

6. Warn users of product dangers and motivate them to avoid injury.

In addition to the elimination of hazards, product warnings and instructions must assist the user to avoid dangers, including those that remain after thorough attempts to eliminate or guard. An explicit warning including a signal word, statement of the hazard, appropriate behavior, and a description of the consequences of the danger are required. A pictogram illustrating the consequences is often needed to communicate the danger, especially to those who cannot read the words. This communication of the consequences is particularly important in motivating the user to avoid the danger.

7. Promote only the safe use of a product.

Advertising and product promotion sometimes subtly and deceptively promote consumer misuse. Motorcycles promoting speeds up to 150 mph certainly encourage users to go fast, if not to the limit.  In the early years of sales, ATVs were advertised as safe, family fun. Print advertisements said the ATVs could traverse “an astonishing array of terrain”, over “rocks, boulders and fallen logs” and “where some animals can’t go.” Small, instantly removed disclaimers are insufficient to warn users of the dangers of actions depicted in advertisements. Positive statements providing safe use instructions with sufficient frequency to influence behavior are necessary to reinforce the safe activity.

8. Maintain safety-related records during the useful life of the product.

An effective product safety system requires records in sufficient detail to allow for timely detection of safety hazards and trends, and for tracing product defects in assembly, components, and overall design. Records necessary to provide sufficient data for management decisions include safety-related product changes, test results, consumer complaints, product liability lawsuits, location of products within the distribution chain, government injury data, and engineering reports. An integral part of the corporate safety policy is the establishment of a system of records and a directive concerning the retention of those documents. A document destruction policy of three years concerning a product with a useful life of seven years deprives the organization of the opportunity to protect product users from danger.

9. Continuously monitor the safety performance of the product in the hands of users.

Once a manufacturer/distributor has concluded that a product is reasonably safe based on pre-production review and analysis, the product is ready for distribution to users. Feedback from product users is critical to determining whether subsequent corrective action is necessary.  A major producer of valves distributed approximately 15,000 valves to OEM manufacturers. Reports from the field indicated the seals were not properly chlorinated, thus allowing the gasket to tear and leak gas. The company notified the Consumer Product Safety Commission under section 15(b) that the product possibly “contained a defect which could create a substantial product hazard”. An appropriate corrective action plan including the recall of the valve and notification to consumers was taken to protect consumers from the dangers of gas explosions.

10. Promptly notify product users and institute recall procedures where necessary to substantially reduce or eliminate injury.

Upon discovery of a product hazard after distribution to the public, immediate notification of the danger and quick steps to protect users from injury is critical. Time is of the essence. Knowledgeable product users can help reduce both injuries and claims. Efficient recall procedures can remove hazardous products from the stream of commerce. A few years ago, a combination of manufacturing flaws turned Toyota’s fleet of vehicles into automotive runaways. In some cases, the floor mats became lodged under the accelerator, jamming it down. In others, the gas pedal would simply stick. After more than 60 cases of runaway vehicles were reported, 30 of which resulted in at least one death, Toyota went into crisis mode and issued two separate recalls in 2009 and 2010 to “reconfigure” the accelerator setup. Company officials have estimated the cost of the blunder will top $5 billion, after all, is said and done, making it the costliest recall ever recorded.

Basic elements of  Product Safety 

Product safety involves the application of the principles of Safety Management to the design and marketing of products. Basic elements of product safety programming are designed to identify and evaluate potential product hazards for systematic control using the techniques of safety management. A Product Safety program must include a clear, explicit, and documented statement of product safety policy. It must include a clear, explicit, and documented assignment of individual responsibility for the conduct of product safety activity. It must also include a clear, explicit, and documented product safety program plan outlining the specific steps, procedures, and techniques to be followed on conducting product safety activity during the product design and marketing processes to achieve product safety goals. As a starting point, a documented search for authoritative literature and relevant standards relating to potential safety concerns associated with the product to be designed or marketed. The conduct of explicit and documented activity giving attention to the systematic discovery or identification of reasonably anticipated potential product or system hazards, followed by an evaluation of those hazards in terms of associated risk factors (likely loss event probability and severity). The documented use of the core concepts and principles of safety management and safety engineering, and the cardinal rules of hazard control, to reasonably eliminate or minimize unacceptable product hazards (though, in order of preference and effectiveness, use of design, safeguarding, or warning means). Product safety programs should appropriately include the following:

1. Corporate Safety Policies
   Safety Product policy is a widely publicized explicit formal statement, as a matter of record, regarding top management’s commitment to state-of-the-art
   product safety and the preeminent importance of product safety during product (system) design, production, and distribution. To establish a policy the organization must:
   • Develop a mission statement to prevent unreasonable risks of injury, signed by the CEO and distributed to all employees.
   • Use all technically feasible and economically practical safety measures to substantially reduce or eliminate injuries, and to meet or exceed all applicable safety standards.
   • Create a multi-disciplinary Safety Review Committee to audit product safety policies and to consider product hazards, the environment of use, and foreseeable consumer behavior.
   • Collect and maintain safety-related data throughout the product life cycle including technical documents, injury data, complaints/returns, product liability litigation, government analyses, and other information concerning the risks of injury.
2. Product Hazards
   • Review the inherent capability of the product to create harm through a transfer of mechanical, thermal, electrical, chemical, biological, or radiation energy.
   • Evaluate injury potential and severity.
   • The study intended and foreseeable product use in concert with operator capabilities based on demographics, anthropometric, educational level, and physical capacity.
3. Foreseeable Use
   • Investigate how injuries occur by reviewing historical data, manuals and instructions, professional journals, and electronic databases.
   • Review government injury databases
   • Analyze internal corporate safety data on product use including customer complaints, warranty returns, toll-free lines, internal intuitive brainstorming sessions, focus groups, surveys, behavioral testing, and computer models.
4. Risk Factors
   • The environment of use including weather, family/peers, job stress, location, ambient conditions, terrain, noise, temperature.
   • Promotion – Marketing, advertising, distribution, public relations, word of mouth, packaging, product form, and shape, point of purchase materials.
   • Vulnerable population groups such as children, seniors, and the disabled, concerning products that exceed the physical or cognitive capabilities of operators.
   • Hazard perception of the user includes the severity of the injury, likelihood or frequency of injury, magnitude of the danger, and prior experiences such as familiarity with product operations, lack of prior injury, overconfidence, and first impression of hazards and risks.
   • Benefit or value of unintended use including time savings, ease of operation, overcoming poor performance, and peer group acceptance.
5. Safety Measures
   • Eliminate the hazard to remove the inherent capability to do harm, or if not possible, place a physical barrier, guard, or interlock between the product hazard and the user.
   • Warn the user of the danger and motivate them to avoid injury using signal words, hazard, pictorial, instructions, and statements of consequences.
   • Promote safety education including safety alerts, injury data, training, owner’s manuals, point of purchase displays.
6. Corrective Action
   • Analysts must monitor the safety performance of products by systematic collection of injury data and other consumer use.
   • When an unreasonable risk is identified, modify future production and initiate a recall applying appropriate safety measures to repair, replace, or repurchase the defective or non-complying products.
   • The public notice includes direct mail, service bulletins, public media, paid advertising, dealer notice, point of sale posters.
   • Government requirements, Defect Notification for Motor Vehicles and Equipment such as child safety seats, and Market Withdrawal and Recall Policies.

Establishing framework for product safety

The risks for organizations and individuals that origin from PS are enormous. For example, Product liability payments are one the most severe management failures that occur because of not handling PS appropriately. Due to the inherent risks of product liability, the application of Reliable Management seems to be a necessary tool. Reliability Management can be defined as taking adequate measures to protect people, the environment, and assets from harmful consequences. Reliable management can be considered as the decisive aspect to actually focus on the essential tasks. Consequently, organizations have the responsibility to allocate their resources according to where they are most required and where most of the risks can potentially be reduced. There is not a way to eliminate risks, but therefore they need to be managed. The organizations need to know, which are their individual and relevant process that has an impact on Product Safety. If organizations have identified them, it will allow them to allocate their available resources according to the importance of the process. This again enhances the chances that tasks are fulfilled according to their requirements.

Laws and regulations can have specific impacts on products and processes. Within Product Safety, they do play a significant role. The legal requirements have their origin from product liability. Product Safety can be considered as the tool, which tries to convert legal requirements from product liability into safe products. The organizations have two main tasks for Product Safety in order to fulfill the legal requirements. Firstly, the creation of safety by the technology. This implies the technical development of a safe product (eg reliability engineering, testing, etc.). Secondly, the creation of safety by an organization that is capable of creating safety (e.g. clear responsibilities, communication, etc.). This needs to be supplemented with the creation of verification data, which allows proving the conformity of manufactured products. This became, due to the increasing numbers of lawsuits, a lot more important. The legal situation states that manufacturers are in the role to prove the product was safe at the time it was launched into the Market. Therefore, these verification records are of crucial character and can actually be decisive for the result of lawsuits. To engineers, legal requirements often seem to be described in a rather general and vague language. In order to fulfill requirements from the law legal requirements can be converted into specific working instructions. Practitioners, which in most cases do not have legal backgrounds, do require legal certainty. They need to know, what their duties are and how they can fulfill these. Therefore, specific working instructions can be created for all the processes that impact product safety.

Method of identifying the processes that are relevant for Product Safety

1. Create a preliminary list of potentially relevant processes for Product Safety
   The first step involves the investigation of which process could possibly have an impact on PS. Therefore, interviews and comprehensive literature reviews regarding the areas of product-creation-process, reliability engineering, and enterprise models are of specific importance. All identified tasks and processes are thereby allocated to the departments that will hold responsibility for process ownership.
2. Discuss preliminary Product Safety process with practitioners and experts from your organization
   During the second step, the preliminary Product Safety process is discussed with experts from the respective departments. A workshop with at least three members from preferably different plants is considered an important instrument to hold this discussion. This has the advantage that the proposed actions are discussed from different angles and different historical backgrounds. The active involvement of future applicants in the identification process is considered a crucial step. People are more likely to accept developments and changes, once they contributed to them. After workshops with all departments have been held, one more workshop with a focus on cross-divisional topics and interfaces between departments is advisable. Eventually, the necessity of this task has to be decided individually.
3. Group and create a short description of all considered Processes
   Within this step, all discussed processes are grouped and consolidated. Next, a short description of each of the processes task with its purpose and goal is being created in order to avoid misunderstandings, when talking about those processes. The thereby existing list can be called ‘Preliminary Processes’.
4. Apply the Product Safety Filter
   The filter distinguishes those activities that actually have a proven impact on Product Safety from those that only seem to be relevant. Eventually, only established process safety processes are qualified for a special treatment, which should ensure that they are conducted in the best possible way. Special treatment means that additional resources or special treatment are involved. Therefore, it is important that organizations identify the correct processes and treat only those with special care. In order to identify the process that has an impact on PS, a set of criteria has been developed. These criteria are derived from the overall goal, which is minimizing product liability risks. This goal is supported if at least one of the following two criteria applies: A special treatment of a task leads to either an improvement of the safety of a product or the minimization of liability risks. Since these two criteria are terms with a wide meaning and purpose, they need to be elaborated in order to ensure the correct filtration.

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