Prevention of Counterfeit Parts in AS9100 Aerospace

INDICATORS OF COUNTERFEIT PRODUCTS IN AEROSPACE (AS9100 STANDARD)

PRODUCT PACKAGING INDICATORS

  1. Inconsistent vendor name on the item and on the shipping container, or no name on the container.

  2. Shipping boxes contain mixed batch numbers, expiration dates and UPC Codes

  3. Unusual packaging and boxing of items

  4. Inconsistent with the manufacturer's normal packaging or documentation requirements

  5. Questionable or meaningless numbers on the item(s) or packaging

  6. Obviously changed labeling - Crossed out or erased

  7. Erroneous OM Logo on the external packaging

INTERNAL PACKAGE INSPECTION

  1. Shipping damage to box/tube/reel/tray

  2. Misspelled wording on the box/tube/reel/tray

  3. Wrong part number on the box/tube/reel/tray

  4. Wrong quantities noted on the box/tube/reel/tray

  5. Barcode mismatch (scanned vs human) on the box/tube/reel/tray

  6. Erroneous OM Logo on the box/tube/reel/tray

  7. Products/Materials not in the original manufacturer's box/tube/reel/tray

  8. Use of Non-ESD Material protected material where necessary by product/material

  9. Products/Materials not in moisture barrier bag

  10. Humidity Indicator Card(HIC) - does change with humidity

  11. Wrong or inconsistent part/material orientation in the tube/reel/tray

  12. Incorrect size of tube/tray

DOCUMENTATION INSPECTION

  1. Misspelled wording in the documentation.

  2. Mismatch in part number or lot number in the documentation

  3. Mismatch in the part quantity in the documentation

  4. Erroneous OM Logo in the documentation

  5. Evidence of tampering in the documentation

AS9100 Aerospace Ethics Policy

Global Principles of Business Ethics for the Aerospace and Defense Industry

Ethical Business Conduct for The Aerospace and Defence Industry - Ethical Business Conduct It is recognized that operating to the highest ethical standards benefits all companies and society. We in the aerospace and defense industry fully acknowledge and support this principle. The Aerospace Industries Association of America (AIA) and AeroSpace and Defence Industries Association of Europe (ASD) have jointly developed these Global Principles of Business Ethics for the Aerospace and Defense Industry (“Global Principles”).

These Global Principles are based on best practices including the Common Industry Standards for European Aerospace and Defence and the Defense Industry Initiative on Ethics and Business Conduct in the US. The aerospace and defense industry’s long term success depends on companies upholding integrity in bidding, negotiating and performing contracts. Companies shall behave ethically towards their customers, suppliers, competitors, employees, and other stakeholders. These Global Principles highlight key issues in the aerospace and defense industry that may impact on ethical business conduct. They are not an exclusive list of business ethics issues that a company may face and which companies themselves should give their staff guidance on. It is intended that the Global Principles will continue to develop over time to reflect current best practices.

INPLEMENTATION

Companies that endorse these Global Principles commit to have comprehensive policies and integrity programmes, and to foster effective practices within their aerospace and defense business operations to implement these Global Principles which shall include: promoting awareness and compliance with the integrity policies of the Company consistent with the Global Principles through appropriate communication and training. encouraging their employees, directors and officers to report all specific concerns that they may have concerning compliance with the integrity policies of the Company consistent with the Global Principles without fear of retaliation. applying appropriate, proportionate and dissuasive sanctions for evidenced cases of non-compliance.

ZERO TOLERANCE TO CORRUPTION

  • Companies will comply fully with all anti-bribery laws applicable to the conduct of their business, such as the U.S. Foreign Corrupt Practices Act (“FCPA”) and those laws enacted pursuant to International Conventions (including, but not limited to, the 1997 OECD Convention and the 2003 United Nations Convention Against Corruption (“UNCAC”)).
  • Companies will not offer, promise, or provide any undue pecuniary or other advantage (e.g. payments, gifts, hospitality, as well as political contributions or charitable donations), to public officials, political parties or political candidates, or to any private party, in order to obtain or retain business or gain any other improper advantage in the conduct of their business.
  • Companies shall duly account for payments, gifts, hospitality, political contributions or charitable donations in their books and records in compliance with applicable regulations and in a manner which permits reasonable traceability.
  • Companies will establish and enforce policies and internal control procedures that prohibit the company and their employees, directors and officers from offering, promising or providing – directly or indirectly – any Improper Advantage, and will conduct training on such policies and procedures.
  • Companies will make their business partners, which term is defined to mean Advisors, majority-owned joint venture entities, subcontractors and suppliers, aware of the integrity policies of the company, and require them to refrain from offering, promising or providing (directly or indirectly) any Improper Advantage.
  • Many countries and companies prohibit facilitation payments. In recognition that such payments undermine the integrity of industry, even where such payments are not prohibited by law, companies will seek to eliminate facilitation payments.

USE OF ADVISORS

  • Advisors include agents, consultants, or intermediaries engaged to assist in developing, expanding or maintaining a Company’s business (e.g. sales, marketing, offsets).
  • Companies will have written policies governing the appointment, management and payment of Advisors.
  • Companies will use capable personnel trained in anti-corruption and compliance issues for the vetting of Advisors.
  • Companies will perform appropriate due diligence using mechanisms which may include independent supplemental investigation/ third party due diligence. Such assessments shall be periodically reviewed.
  • Companies will pay an appropriate remuneration to their Advisors. Remuneration shall reflect legitimate services effectively rendered and shall be based on the most objective elements possible. No payments shall be made in cash.
  • Payments shall only be for Ethical Business Conduct for The Aerospace and Defence Industry –made, save in exceptional circumstances, in the country where the Advisor is active or registered. These payments shall be properly recorded in the Company’s books and records.

Companies shall make Advisors aware of: 

(i) the integrity policies of the Company which shall be consistent with the Global Principles, and (ii) the legal provisions containing the incrimination of bribery of foreign public officials pursuant to the U.S. FCPA, the 1997 OECD Convention, and the UNCAC, as each applies.

Companies shall have an agreement concluded in a written form between the Company and all of its Advisors, which shall contain a provision whereby the latter commits to comply at all times with the provisions mentioned above and more specifically that no part of any payment originating from the Company will be passed on as a bribe. Companies should require that Advisors will inform the Company regularly and on an ongoing basis on the accomplishment of his, her, or its tasks and duties.

RESPECT FOR PROPRIETARY INFORMATION

Companies shall keep proprietary information of third parties to which they have gained access in accordance with the terms of its disclosure and in strict compliance with all applicable laws and regulations. Companies will not solicit or accept a third party’s proprietary information (whether provided by a customer or otherwise), such as bid and proposal information, or technical or price data, unless the owner of the data has agreed to its release.

Companies who receive a third party’s proprietary information without authorization:

  1. shall promptly cease dissemination and review of such information;
  2. shall promptly destroy or return such information; and
  3. should inform the third party of the incident and their response.

MANAGING CONFLICTS OF INTEREST

  • Companies shall follow all applicable laws, regulations and directives concerning the employment or engagement of public officials including those dealing with conflicts of interest.
  • Companies will maintain policies to address or mitigate the risk of undue or improper conflicts of interest. 

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Changes coming to R2 Recycling Standard

The R2 Technical Advisory Committee (TAC) held an in-person meeting last month to continue work on revisions to the R2 Standard.   A number of suggested revisions were considered for inclusion in the upcoming draft of the R2 Standard revision.  A draft of the revised R2 Standard is anticipated to be released for public comment in late 2017.   

During the course of its discussions, the TAC agreed on the following issues (any proposed changes must be approved by the Consensus Body, be posted for public comment, and ratified by the SERI Board before taking effect):

The R2 Standard should remain broadly written, applicable to all materials and processing within the scope of R2.  Exceptions for managing specific materials should not be written into the standard. 

The hierarchy under Provision 2 should not add a “beneficial use” level between Materials Recovery and Energy Recovery or Land Disposal.

Life-cycle analysis is helpful when make recycling decisions, but too subjective (because of variations in the factors considered) to incorporate into the R2 Standard at this time. 

Enhance the FM Management Plan (Provision 5.a) requirements.

Improve the transparency of the downstream recycling chain (Provision 5.e.6).

Require notification to upstream suppliers when vendors in the downstream recycling chain are added or removed.

Reorganize Provision 6 to improve clarity of the testing and reuse requirements, including renaming of the reuse categories.

Improve Provision 7 with requirements to ensure consistency and clarity of throughput records, including demonstrated proof of receipt.

Require maximum inventory levels in Provision 7 consistent with the closure plan.

The TAC also agreed to changes to the Guidance for Provision 11 regarding sufficient financial instruments, closure planning, and insurance, which will be published in the coming months.  

Plastics Recycling of E-Scrap

Plastic E-Waste

More and more recyclers are looking for ways to recycle plastic e-waste through innovative technologies and equipment.

The first thing that comes up in any conversation about e-plastics is the inherent complexity of the stream. The resins in question, the downstream markets for the material and the way plastics are used in today’s electronic devices – all are marked by nuance and complications.

It’s no surprise then that successfully pulling plastics out of the electronics recycling stream is far from straightforward. Sorting, recycling and marketing the plastics content in end-of-life devices can be painstaking, not to mention economically challenging.

“Your average plastics recycler wants nothing to do with it,” said Andrew Rubin, president of FCM Recycling, a Canadian electronics recycling company that recently invested heavily in infrastructure to recover e-plastics.

However, despite the difficulties, it’s becoming increasingly important for the plastics recycling industry to try to move forward in this realm because plastics usage in electronics is rising rapidly. As a recent report from the Plastics Industry Association highlighted, the material is a favorite among original equipment manufacturers.

“Across the consumer electronics spectrum, plastics offers benefits no other material can replicate,” the report states.
To help plastics industry entities better understand the e-plastics world, we checked in with a number of companies that are handling recovered electronics everyday to get a look at the emerging trends on the plastics side – and to better understand the processes and thinking that may lead to e-plastics progress.

Tough to track total tonnages

One of the overarching challenges in the e-plastics recycling realm is the absence of comprehensive data. The U.S. EPA does not currently track the generation or recovery of plastics found in consumer electronics, and individual state electronics recycling programs rarely require recycling companies to report on e-plastics recovery.

What we do know is there’s a lot of it out there. According to a 2016 study from the National Center for Electronics Recycling (NCER), just over 2.1 billion pounds of electronics ended up in the U.S. waste stream in 2015. While the report did not detail how much of that material consisted of e-plastics, it provided a telling breakdown of the plastics content in your typical end-of-life device.

According to the report, by weight a typical CRT device hitting the waste stream contains approximately 12 to 15 percent e-plastics while flat screen devices are made up of 20 to 24 percent e-plastics. About half of the weight of a printer comes from its e-plastics content, the report shows, and keyboards and mice are made up of more than 80 percent e-plastics.

Over the years, an increasingly wide range of plastics have been used in consumer electronics, including acrylonitrile butadiene styrene (ABS), high impact polystyrene (HIPS) and expanded polystyrene (EPS) (See Sidebar 1 for an e-plastics glossary).

But not all devices utilize the same resins. According to Tom Bolon, the president of Columbus, Ohio-based Novotec Recycling, CRT monitor housings generally contain PC/ABS, but CRT TV housings often consist of HIPS. Meanwhile, flat panels are a mix of PC/ABS or HIPS.

Printers can have “up to four or five different plastics,” he noted, while the fronts and backs of TVs and monitors are often made with two different resin types. “E-plastics are a tough category due to the variety and complexity of the original recyclable that they are derived from,” Bolon said.

A typical e-scrap recycling operation in the U.S. will dismantle the electronic devices they receive and eventually send them through a shredding system, which produces a mix of plastics, metals, glass and other contaminants. Processors committed to recycling e-plastics will attempt to sort the plastics out through manual or automated separation systems, ideally producing homogenous streams for downstream buyers.

It’s an uphill climb, says Duane Beckett, the president of Brockport, N.Y.-based Sunnking Recycling.

“Recyclable plastics are kept separate into as clean of a stream as we can make it, much like any metal category that we separate into and sell,” Beckett said. “Plastics recyclers in general are very finicky with regards to the materials they accept.”

A typical flat screen monitor is made up of 20 to 24 percent plastic by weight, but variety and complexities in the material mix make e-plastics from a range of devices difficult to cost-effectively recycle.

While Sunnking mostly attempts to recover the ABS plastics found in CRT and flat panel devices, Beckett noted not all electronics recycling operations have the necessary equipment or interest in handling the material. What doesn’t get recycled heads to landfill, “representing a significant cost over time,” Beckett noted.

Impediments to recovery

Beyond the sheer array of plastics found in consumer electronics, the use of brominated flame retardants (BFRs) has also been a historical barrier to recovery.

While many original equipment manufacturers have moved away from using BFRs in their products, older equipment, particularly TVs and computers, can still often contain the chemical mix. As the U.S. Environmental Protection Agency notes on its website, “Many flame retardant chemicals can persist in the environment, and studies have shown that some may be hazardous to people and animals.”

At present, there are no regulatory restrictions for incorporating recycled plastics with BFRs into new products in the U.S., but the domestic market remains limited. According to FCM’s Rubin, a “stigma” often surrounds BFR-containing recycled plastics, with most North American buyers interested in only non-BFR plastics at this point.

“Non-BFR plastics are hard to come by and [come] at a premium,” he said, noting that most North American recycling companies are forced to ship e-plastics abroad for further recycling.

The European Union restricted the use of BFRs in electronic products in 2003 under the Restriction of Hazardous Substances Directive. The EPA, meanwhile, is continuing to study BFRs in accordance with the Toxic Substances Control Act for potential human health and environmental risks.

Another major impediment to e-plastics recovery in the U.S. comes down to simple economics. The value of e-plastics is often not worth the labor to attempt to separate the material.

“Mixed plastics [is] one of the lowest and least valuable of materials categories, and one of the most common materials streams derived from electrical and electronic equipment,” the NCER report from last year states. “The incredibly low value of this material underscores the challenges in assuming profitable recycling for all devices.”

According to the report, mixed plastics found in TVs, computers and printers had little to no recovery value. Electronic recycling companies largely echo that sentiment today.

Bolon from Novotec said the value of mixed e-plastics today ranges “from zero to a couple of cents” per pound.

Sean Magann, a vice president at Sims Recycling Solutions, said the company is able to move its e-plastics downstream despite its low value.

“The price is not what we’d like, but it’s our commitment to make sure the plastic is recycled,” Magann said.

Most e-plastics that are being recycled head to foreign markets, with China being the most popular destination for the material (see sidebar above). “They have the need for the plastic and the labor and technology to do more efficient separations than are generally possible in the U.S,” Bolon said.

“You can separate and regrind and develop domestic markets for recycled e-waste plastics,” he continued, “but it is a specialty and requires a lot of work and patience since the market changes all the time. And cheap virgin material can come in from China any time and eliminate a client’s orders quickly.”

Beckett from Sunnking said domestic outlets for e-plastics are hard to come by.

“We do not see any domestic outlets. The streams are too contaminated for any reuse opportunities in the U.S. without a significant investment in sorting equipment,” Beckett said.

Pushing e-plastics recovery forward

One company that has made such an investment, however, is FCM Recycling.

The Canadian electronics recycling company recently opened up a facility in Quebec that is dedicated to processing up to 15,000 metric tons of e-plastics a year. The company invested heavily in the operation – over $4 million in research and development and equipment.

“It was very clear to us as time evolved that plastics was becoming more and more representative in the waste stream,” said FCM’s Rubin.

The e-plastics site operated by FCM expects to process about 5,000 metric tons of material in 2017, all of which is being recycled in North America and used in a range of products, including construction shims, flower pots and trays and sheets used to manufacture various products.

In addition to utilizing a proprietary sorting process to successfully separate the various plastics, the plant utilizes grinders, air classification systems and metal detection systems.

“The markets are there. What it comes down to is making the investment in the equipment to bring it to a level where it’s usable,” Rubin explained. “You have to make the investment to separate the material, to grind the material down, to melt the material and re-pelletize it. If you get it to a pelletized form, there are plenty of markets for the material.”

Rubin also addressed the challenges associated with BFRs. “The material is perfectly safe and works just the same as any non-BFR material,” he noted. “You don’t want to put it in children’s toys and food, but apart from that, it has no effect on production and it doesn’t need to be handled specially.”

A related piece of the e-plastics recovery puzzle is generating enough large-scale and consistent demand to convince recovery firms to invest in equipment. Many have pointed to the need for original equipment manufacturers (OEMs) in the electronics industry to close the loop on their products and reincorporate recovered e-plastics into new products.

One example of such activity can be seen at computer giant Dell, which works alongside manufacturer Wistron to bring recovered e-plastics into new products. Dell has operated a take-back program for years that allows the company to source and control its recycled feedstock directly. In 2014, Dell released its first computer featuring recycled e-plastic: the OptiPlex 3030 All-in-One desktop.

“The closed-loop process delivers an energy-efficient product made from recycled content that is nominally less expensive, with the potential to show greater cost savings as the program scales,” Dell notes on its website.

What’s needed to push recovery forward

Steve Skurnac, the global president at Sims Recycling Solutions, said better resin separation and further OEM support could help catalyze domestic markets for e-plastics.

“Better resin separation will drive higher prices and manufacturers trying to close the loop may sponsor plastic recycling and remanufacturing initiatives with recyclers,” Skurnac said.

Bolon of Novotec noted that obtaining enough supply is crucial to developing markets further downstream, especially when it comes to manufacturers.

“For any plastic, no matter how clean it is, if you don’t have enough volume, there is no market,” Bolon said. “A manufacturer has to be able to rely on a constant supply of the same exact product in order to set up a line or product.”

Sunnking’s Beckett also pointed out that recycling companies have to be willing to make the investment to separate e-plastics by resin type and then store material in order to produce a marketable commodity.

“Unless a processor has a large facility or a baler, loose plastics take a large amount of floor or gaylord space,” said Beckett. “This is also costly.”

But as complex as the e-plastics stream may be, electronics processors are beginning to see it as an important commodity stream in the years ahead and one that will, at some point or another, drive investment.

“It’s only a matter of time that new and novel solutions pop up to treat this material here in North America,” FCM’s Rubin said. “Everyone knows that.”

ISO Provides guidance on documented Information as part of ISO 9001:2015

1 Introduction 

Two of the most important objectives in the revision of the ISO 9000 series of standards have been: 

a) to develop a simplified set of standards that will be equally applicable to small as well as medium and large organizations, and 

b) for the amount and detail of documentation required to be more relevant to the desired results of the organization’s process activities. 

ISO 9001:2015 Quality management systems – Requirements has achieved these objectives, and the purpose of this additional guidance is to explain the intent of the new standard with specific regard to documented information. 

ISO 9001:2015 allows an organization flexibility in the way it chooses to document its quality management system (QMS). This enables each individual organization to determine the correct amount of documented information needed in order to demonstrate the effective planning, operation and control of its processes and the implementation and continual improvement of the effectiveness of its QMS. 

It is stressed that ISO 9001 requires (and always has required) a “Documented quality management system”, and not a “system of documents”. 

2 What is documented information? - Definitions and references 

The term Documented information was introduced as part of the common High Level Structure (HLS) and common terms for Management System Standards (MSS). 

The definition of documented information can be found in ISO 9000 clause 3.8. 

Documented information can be used to communicate a message, provide evidence of what was planned has actually been done, or knowledge sharing. 

The following are some of the main objectives of an organization’s documented information independent of whether or not it has implemented a formal QMS; 

a) Communication of Information 

- As a tool for information transmission and communication. The type and extent of the documented information will depend on the nature of the organization’s products and processes, the degree of formality of communication systems and the level of communication skills within the organization, and the organizational culture. 

b) Evidence of conformity 

- Provision of evidence that what was planned has actually been done. 

c) Knowledge sharing 

d) To disseminate and preserve the organization’s experiences. A typical example would be a technical specification, which can be used as a base for design and development of a new product or service. 

A list of commonly used terms and definitions relating to documented information is presented in ISO 9001:2015 Annex A. 

It must be stressed that, according to ISO 9001:2015 clause 7.5.3 Control of documented information requirements, documents may be in any form or type of medium, and the definition of “document” in ISO 9000:2015 clause 3.8.5 gives the following examples: 

− paper 

− magnetic 

− electronic or optical computer disc 

− photograph 

− master sample 

3 ISO 9001:2015 Documentation Requirements 

ISO 9001:2015 clause 4.4 Quality management systems and its processes requires an organization to “maintain documented information to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confident that the processes are being carried out as planned.” 

Clause 7.5.1 General explains that the quality management system documentation shall include: 

a) documented information required by this International standard; 

b) documented information determined by the organization as being necessary for the effectiveness of the quality management system 

The note after this Clause make it clear that the extent of the QMS documented information can differ from one organization to another due to the: 

a) size of organization and its type of activities, processes, products and services; 

b) complexity of processes and their interactions, 

c) competence of persons. 

All the documented information that forms part of the QMS has to be controlled in accordance with clause 7.5 Documented information. 

4 Guidance on Clause 7.5 of ISO 9001:2015 

The following comments are intended to assist users of ISO 9001:2015 in understanding the intent of the general documented information requirements of the International Standard. Documented information can refer to: 

a) Documented information needed to be maintained by the organization for the purposes of establishing a QMS (high level transversal documents). These include: 

− The scope of the quality management system (clause 4.3). 

− Documented information necessary to support the operation of processes (clause 4.4). 

− The quality policy (clause 5.). 

− The quality objectives (clause 6.2). 

− This documented information is subject to the requirements of clause 7.5. 

b) Documented information maintained by the organization for the purpose of communicating the information necessary for the organization to operate (low level, specific documents). See 4.4. Although ISO 9001:2015 does not specifically requires any of them, examples of documents that can add value to a QMS may include: 

− Organization charts 

− Process maps, process flow charts and/or process descriptions 

− Procedures 

− Work and/or test instructions 

− Specifications 

− Documents containing internal communications 

− Production schedules 

− Approved supplier lists 

− Test and inspection plans 

− Quality plans 

− Quality manuals 

− Strategic plans 

− Forms 

Where it exists, all such documented information, is also subject to the requirements clause 7.5. 

c) Documented information needed to be retained by the organization for the purpose of providing evidence of result achieved (records). These include: 

− Documented information to the extent necessary to have confidence that the processes are being carried out as planned (clause 4.4). 

− Evidence of fitness for purpose of monitoring and measuring resources (clause 7.1.5.1). 

− Evidence of the basis used for calibration of the monitoring and measurement resources (when no international or national standards exist) (clause 7.1.5.2). 

− Evidence of competence of person(s) doing work under the control of the organization that affects the performance and effectiveness of the QMS (clause 7.2). 

− Results of the review and new requirements for the products and services (clause 8.2.3). 

− Records needed to demonstrate that design and development requirements have been met (clause 8.3.2) 

− Records on design and development inputs (clause 8.3.3). 

− Records of the activities of design and development controls (clause 8.3.4). 

− Records of design and development outputs (clause 8.3.5). 

− Design and development changes, including the results of the review and the authorization of the changes and necessary actions (clause 8.3.6). 

− Records of the evaluation, selection, monitoring of performance and re-evaluation of external providers and any and actions arising from these activities (clause 8.4.1) 

− Evidence of the unique identification of the outputs when traceability is a requirement (clause 8.5.2). 

− Records of property of the customer or external provider that is lost, damaged or otherwise found to be unsuitable for use and of its communication to the owner (clause 8.5.3). 

− Results of the review of changes for production or service provision, the persons authorizing the change, and necessary actions taken (clause 8.5.6). 

− Records of the authorized release of products and services for delivery to the customer including acceptance criteria and traceability to the authorizing person(s) (clause 8.6). 

− Records of nonconformities, the actions taken, concessions obtained and the identification of the authority deciding the action in respect of the nonconformity (clause 8.7). 

− Results of the evaluation of the performance and the effectiveness of the QMS (clause 911) 

− Evidence of the implementation of the audit programme and the audit results (clause 9.2.2). 

− Evidence of the results of management reviews (clause 9.3.3). 

− Evidence of the nature of the nonconformities and any subsequent actions taken (clause 10.2.2).; 

− Results of any corrective action (clause 10.2.2). 

Organizations are free to develop other records that may be needed to demonstrate conformity of their processes, products and services and quality management system. Where they exists, all such records are also subject to the requirements clause 7.5. 

 

5 Organizations preparing to implement a QMS 

For organizations that are in the process of implementing a QMS, and wish to meet the requirements of ISO 9001:2015, the following comments may be useful. 

− For organizations that are in the process of implementing or have yet to implement a QMS, ISO 9001:2015 emphasizes a process approach. This includes: 

▪ determining the processes necessary for the effective implementation of the quality management system 

▪ determining the interactions between these processes. 

▪ documenting the processes to the extent necessary to assure their effective operation and control. (It may be appropriate to document the processes using process mapping tools. It is emphasized, however, that documented process mapping tools are not a requirement of ISO 9001:2015). 

− Analysis of the processes should be the driving force for defining the amount of documented information needed for the quality management system, taking into account the requirements of ISO 9001:2015. It should not be the documented information that drives the processes. 

6 Organizations wishing to adapt an existing QMS 

For organizations that currently have a QMS the following comments are intended to assist in understanding the changes to documented information that may be required or facilitated by the transition to ISO 9001:2015.

− An organization with an existing QMS should not need to rewrite all of its documented information in order to meet the requirements of ISO 9001:2015. This is particularly true if an organization has structured its QMS based on the way it effectively operates, using a process approach. 

− An organization may be able to carry out some simplification and/or consolidation of existing documented information in order to simplify its QMS. 

7 Demonstrating conformity with ISO 9001:2015 

For organizations wishing to demonstrate conformity with the requirements of ISO 9001:2015, for the purposes of certification/registration, contractual, or other reasons, it is important to remember the need to provide evidence of the effective implementation of the QMS. 

− Organizations may be able to demonstrate conformity without the need for extensive documented information 

− To claim conformity with ISO 9001:2015, the organization has to be able to provide objective evidence of the effectiveness of its processes and its quality management system. Clause 3.8.3 of ISO 9000:2015 defines “objective evidence” as “data supporting the existence or verity of something” and notes that “objective evidence may be obtained through observation, measurement, test, or other means.” 

− Objective evidence does not necessarily depend on the existence of documented information, except where specifically mentioned in ISO 9001:2015. In some cases, (for example, in clause 8.1 (e) Operational planning and control, it is up to the organization to determine what documented information is necessary in order to provide this objective evidence. 

− Where the organization has no specific documented information for a particular activity, and this is not required by the standard, it is acceptable for this activity to be conducted using as a basis the relevant clause of ISO 9001:2015. In these situations, both internal and external audits may use the text of ISO 9001:2015 for conformity assessment purposes. 

Source: www.iso.org/tc176/sc02/public

TS16949:2016 adds long list of requirements

In 2014, the International Automotive Task Force (IATF) reported that the automotive industry wouldn’t upgrade the ISO/TS 16949 standard to ISO 9001:2015, much to the dismay of Tier One suppliers. In a survey that same year, Tier One suppliers related their desire to update their management systems to ISO 9001. Additionally, they weren’t happy with the industry’s onerous customer-specific requirements.

It’s interesting to note that many years ago, QS-9000, the predecessor to ISO/TS 16949, was written to reduce the proliferation of standards in the automotive industry. The number of new requirements coming from both the OEMs and Tier Ones in the last few years definitely looks like a return to the pre-QS-9000 days.

The IATF took two steps based on this feedback from Tier One suppliers. First, they would update ISO/TS 16949 to ISO 9001:2015, and that they were going to create a task force to do so. Second, they would try to understand customer needs before embarking on the change.

When evaluating a new draft standard against the current ISO/TS 16949, the following forces come into play (figure 1):

Recent ethical scandals in industry, autonomous cars, automatic braking, and Tier One needs for simplifying customer-specific requirements are the main drivers of ISO/TS 16949:2016. The recent National Highway Traffic Safety Administration (NHTSA) announcement brought about an agreement with 20 OEMS to equip all new light-duty vehicles with automatic braking and forward-collision warning by 2022. This agreement and the race toward autonomous and semiautonomous vehicles have spurred a focus on product safety and embedded software for this update. And due to a few OEM recalls and poor Corporate Average Fuel Economy (CAFE) ratings, there will also be a requirement for corporate responsibility. A number of customer-specific requirements will be addressed as well to reduce differences in these requirements between OEMs and Tier Ones.

ISO/TS 16949:2016 changes

The quality management standard ISO 9001:2015 has major changes itself, including the addition of context, interested-party expectations, planning, and risk-based thinking. These will have to be considered along with the additions planned for ISO/TS 16949:2016.

Determining the number of “shalls” in these two standards allows us to make some interesting comparisons:
1. ISO/TS 16949 has twice the number of “shalls” than ISO 9001:2015.
2. There are 38 new “shalls” or requirements in ISO/TS 16949 from the IATF. These represent roughly 30 percent of the ISO 9001:2015 requirements.
3. Most of the new requirements for ISO/TS 16949 are found in Clause 8--“Operation,” which includes “product realization” from the previous standard.

Changes ISO/TS 16949:2016

The running changes in ISO/TS 16949 are product safety and embedded software. In fact, there’s a requirement for organizations to conduct audits using the Automotive Software Process Improvement Capability Determination (SPICE) for internal and supplier-embedded software. To help reduce customer-specific requirements between the OEMs, internal auditor competencies will be added to the audit requirements. Also prominent are requirements for CQI-14 Warranty Management and CQI-19 Sub-Tier Supplier Management. There are nine identified key changes in the ISO/TS 16949:2016 draft.

Timing

ISO/TS 16949:2016 is expected to be released during the fourth quarter of 2016. The deadline for global implementation is Sept. 14, 2018 which is inline with the current expiry of the ISO 9001:2008 standard. Suppliers to the automotive industry must meet this challenge head on due to the number of significant changes, opportunities for improvement, and tight deadlines. 

AS9100 Rev D

The aerospace standard AS9100 Revision D was originally planned to be released in April 2014. However, this was not the case; the IAQG decided to release the English version, along with all the required IAQG language, in October 2016.

The late release of the standard, coupled with the September 2018 transition deadline date remaining unchanged, increases the pressure on organizations planning on transitioning to AS9100 Rev. D.

Let’s explore the challenges to organizations planning their transition by first understanding the changes that AS9100 Rev. D reflects; deciding on which of the other AS standards should be implemented along with AS9100 Rev. D.

AS9100 Rev. D changes

AS9100 Rev. D is built on a base of the recently revised quality management system standard ISO 9001:2015. The drivers of AS9100 Rev. D are the changes found in ISO 9001:2015, along with aerospace additions and other IAQG standards. When AS9100 Rev. D is compared to AS9100 Rev. C, it’s evident that the number of additional “shalls” in AS9100 Rev. D is 66 vs. 53 “shalls” in AS9100 Rev. C. (See figure 1 below.)

 Figure A: Comparison of "Shalls" in AS9100 Rev C and Rev D

Figure A: Comparison of "Shalls" in AS9100 Rev C and Rev D

There are nine subclauses in AS9100 Rev. D vs. 10 subclauses in AS9100 Rev. C. There are two new subclauses in AS9100 Rev. D, which are 8.1.3—“Product safety” and 8.1.4—“Prevention of counterfeit parts.” However, 30 percent of the additional “shalls” were in “Measurement, analysis and improvement” in AS9100 Rev. C, and only 3 percent were in “Performance evaluation” for AS9100 Rev. D.

Product safety, counterfeit parts, and human factors are the big differences between AS9100 Rev. D and Rev. C. The subclause 8.1.3—“Product safety” has not only been added, but also appears in five additional areas of the standard. 8.1.4—“Counterfeit parts” likewise has been added and shows up in three additional areas of the standard. “Human factors” has been added to 10.2—“Nonconformity and corrective actions.” The other changes reflect movement of the clauses from the process model structure in AS9100 Rev. C to the plan-do-check-act (PDCA) structure of AS9100 Rev. D. (See Below)

 Figure B: Changes to AS9100 Revision C and D.

Figure B: Changes to AS9100 Revision C and D.

When AS9100 Rev. D is compared to AS9100 Rev. C, the changes in the additional aerospace requirements are not as significant as the changes in the base ISO 9001:2015 standard.

Changes in ISO 9001:2015

There are 18 changes in ISO 9001:2015 compared to ISO 9001:2008. Some of the significant changes include the High-Level Structure change. Also, there is the addition of Context, Interested-party expectations, and risk-based thinking as three of the biggest changes in the standard.

Context, interested-party expectations, and objectives

“Context” is a term that has been hot in business circles during the last few years. Context, or “contextual intelligence,” has been associated with setting company strategy. The argument has been that companies need to consider the context of the organization when they design their strategy, goals, and objectives. 

“Context matters." Context, has entered into our lexicon from a business perspective. An organization’s context, both internal and external, will influence the policy, objectives, and processes of the quality management system (QMS). ISO 9001 says that an organization needs to identify the internal and external issues “relevant to the purpose and the strategic direction and that affect its ability to achieve the intended result(s).” In a note, ISO 9001:2015 suggests that both internal and external issues must be developed when determining the context of the organization. The external context needs to consider issues from legal, technological, competitive, market, cultural, social, and economic environments, whether international, national, regional, or local. Internal context needs to consider issues related to values, culture, knowledge, and performance.

The organization then identifies not only customer expectations, but also interested-party expectations. ISO 9001:2015 scopes interested parties and their requirements to those that are relevant to the QMS.

Once the issues related to the context as well as interested-party expectations and requirements are identified, what’s next for the organization?

The organization uses the context and the strategic direction to formulate the quality policy and objectives (subclause 5.1.1 b). The organization also uses the context and the interested-party expectations to determine the risks and opportunities, and subsequently, the actions to address them (subclauses 6.1.1 and 6.1.2). Strategy is defined as planned activities to achieve an objective (subclause 3.35), and hence, strategic direction can be thought of as the mission and vision that define the quality policy and objectives.

Risk-based thinking

Many aerospace organizations thought that subclause 7.1.2—“Product realization risk” in AS9100 Rev. C would suffice for meeting the requirements of ISO 9001:2015. However, ISO 9001:2015’s risk-based thinking is more comprehensive; clause 6.1 is about planning risk or the risk and opportunities of not meeting “intended outcomes.”

Leadership

Another big change found in AS9100 Rev. D is the expectations and accountability of top management. Even though responsibilities can be delegated, accountability is with top management. Top management is responsible for AS9100 performance, ensuring that senior management perform their responsibilities and that AS9100 is functioning satisfactorily. In short, top management is in for a major surprise if they think that it’s “business as usual.” 

In short, ISO 9001:2015 changes affect AS9100 Rev. D significantly, and implementers must understand these requirements as they plan their implementations.

Other AS9100 standards

AS 9100 Rev. D identifies 16 additional standards that can be integrated into AS9100 as various clauses are being implemented.  AS9101 is another important aerospace standard relating to audits.  AS9102, concerning first-article inspection, and AS9103 on variation management are both key aerospace standards to consider as well. Another standard which is critical for organizations in the aerospace industry is AS9145 for aerospace APQP and PPAP. Organizations need to adopt this standard for two major reasons: it’s required by most aerospace OEMs, including Bombardier, Air Bus, Embraer, Rolls Royce, UTC, Parker, and others; and it helps reduce on-time and quality risks in a product launch.

Transition timelines

There are four key dates for AS9100-registered companies. The first is when the official AS 9100:2016 standard will be released in October 2016. The second key date is June 2017, which is the deadline past which no new AS9100 Rev. C companies will be accepted, and also the deadline for when registrars will stop using AS9100 Rev. C in surveillance audits. The third key date is September 2017, when all AS9100 companies must provide their transition dates and plans to their registrars. The final key date for AS9100 Rev. D is September 2018, when organizations are required to be registered to AS9100 or else lose their AS9100 certification. 

 Figure C: Major Target dates for AS9100 Revision D

Figure C: Major Target dates for AS9100 Revision D

Companies can start their transitions now.  Organizations will need to conduct a gap assessment and formulate their implementation plans, train their implementer, auditors, and top management. 

ISO 14001:2015 is here!

 ISO 14001:2015 has been released.

ISO 14001:2015 has been released.

One of the world's most popular standards for environmental management has just been revised, with key improvements that make it fit for the future.

 ISO 14001:2015, which sets out the requirements for an environmental management standard, is one of the world’s most widely used standards and a key business tool for many organizations. With more than 300 000 certificates currently issued around the world, it ranks high on the agenda of many organizations worldwide who place importance on their environmental impact.

A newly revised version has just been published, to ensure it remains relevant to the marketplace. ISO 14001:2015 responds to the latest trends, such as an increasing recognition by companies of the need to factor in both external and internal elements that influence their impact, including climate volatility.

Other key improvements in the new version include:

  • A greater commitment from leadership
  • An increased alignment with strategic direction
  • Greater protection for the environment, with a focus on proactive initiatives
  • More effective communication, driven through a communications strategy
  • Life-cycle thinking, considering each stage of a product or service, from development to end-of-life

The newly revised ISO 14001 reflects many changes in technology and what stakeholders expect of organizations.  Being ISO 14001 also acts as a competitive advantage and something that organizations can use to distinguish themselves from their competition and providing financial advantage to realize efficiencies and improve performance.

 

What is Risk Based Thinking?

1. What is risk-based thinking?

Risk-based thinking is something we all do automatically.

Example: If I wish to cross a road I look for traffic before I begin. I will not step in front of a moving car.

Risk-based thinking has always been in ISO 9001 – this revision builds it into the whole management system.

In ISO 9001:2015 risk is considered from the beginning and throughout the standard, making preventive action part of strategic planning as well as operation and review.

Risk-based thinking is already part of the process approach.

Example: To cross the road I may go directly or I may use a nearby footbridge. Which processI choose will be determined by considering the risks.

Risk is commonly understood to be negative. In risk-based thinking opportunity can also be found – this is sometimes seen as the positive side of risk.

Example:

Crossing the road directly gives me an opportunity to reach the other side quickly, but there is an increased risk of injury from moving cars.

The risk of using a footbridge is that I may be delayed. The opportunity of using a footbridge is that there is less chance of being injured by a car.

Opportunity is not always directly related to risk but it is always related to the objectives. By considering a situation it may be possible to identify opportunities to improve.

Example:

Analysis of this situation shows further opportunities for improvement:

  •        a subway leading directly under the road
  •       pedestrian traffic lights, or
  •      diverting the road so that the area has no traffic

It is necessary to analyse the opportunities and consider which can or should be acted on. Both the impact and the feasibility of taking an opportunity must be considered. Whatever action is taken will change the context and the risks and these must then be reconsidered.

2. Where is risk addressed in ISO 9001:2015?

INTRODUCTION

The concept of risk-based thinking is explained in the introduction of ISO 9001:2015.

DEFINITIONS

ISO 9001:2015  defines risk as the effect of uncertainty on an expected result.

  1. An effect is a deviation from the expected – positive or negative.
  2. Risk is about what could happen and what the effect of this happening might be
  3. Risk also considers how likely it is

The target of a management system is achieve conformity and customer satisfaction.

ISO 9001:2015 uses risk-based thinking to achieve this in the following way:

Clause 4 (Context) the organization is required to determine the risks, which may affect this.

Clause 5 (Leadership) top management are required to commit to ensuring Clause 4 is followed.

Clause 6 (Planning) the organization is required to take action to identify risks and opportunities.

Clause 8 (Operation) the organization is required to implement processes to address risks and opportunities.

In Clause 9 (Performance evaluation) the organization is required to monitor, measure, analyse and evaluate the risks and opportunities.

In Clause 10 (Improvement) the organization is required to improve by responding to changes in risk.

3. Why use risk-based thinking?

By considering risk throughout the organization the likelihood of achieving stated objectives is improved, output is more consistent and customers can be confident that they will receive the expected product or service.

Risk-based thinking therefore:

  •        builds a strong knowledge base
  •        establishes a proactive culture of improvement
  •        assures consistency of quality of goods or services
  •        improves customer confidence and satisfaction

Successful companies intuitively take a risk-based approach

4. How do I do it?

Use a risk-driven approach in your organizational processes.

Identify what YOUR risks and opportunities are – it depends on context

Example

If I cross a busy road with many fast-moving cars the risks are not the same as if the road is small with very few moving cars. It is also necessary to consider such things as weather, visibility, personal mobility and specific personal objectives.

Analyse and prioritize your risks and opportunities

What is acceptable, what is unacceptable? What advantages or disadvantages are there to one process over another?

Example

Objective:  I need to safely cross a road to reach a meeting at a given time.

It is UNACCEPTABLE to be injured.

It is UNACCEPTABLE to be late.

The opportunity of reaching my goal more quickly must be balanced against the likelihood of injury. It is more important that I reach my meeting uninjured than it is for me to reach my meeting on time.

It may be ACCEPTABLE to delay arriving at the other side of the road by using a footbridge if the likelihood of being injured by crossing the road directly is high.

I analyse the situation. The footbridge is 200 metres away and will add time to my journey. The weather is good, the visibility is good and I can see that the road does not have many cars at this time.

I decide that walking directly across the road carries an acceptably low level of risk of injury and an opportunity to reach my meeting on time.

Plan actions to address the risks

How can I avoid or eliminate the risk? How can I mitigate risks?

Example: I could eliminate risk of injury by using the footbridge but I have already decided that the risk involved in crossing the road is acceptable.

Now I plan how to reduce the likelihood of injury and/or the effect of injury. I cannot reasonably expect to control the effect of a car hitting me. I can reduce the probability of being hit by a car. 

I  plan to cross at a time when there are no cars moving near me and so reduce the likelihood of an accident. I also choose to cross the road at a place where I have good visibility and can safely stop in the middle to re-assess the number of moving cars, further reducing the probability of an accident.

Implement the plan – take action

Example

 I move to the side of the road, check there are no barriers to crossing and that there is a safe place in the centre of the moving traffic. I check there are no cars coming.  I cross half of the road and stop in the central safe place. I assess the situation again and then cross the second part of the road.

Check the effectiveness of the actions – does it work?

Example

 I arrive at the other side of the road unharmed and on time:  this plan worked and undesired outcomes have been avoided.

Learn from experience – continual improvement

Example

I repeat the plan over several days, at different times and in different weather conditions.

This gives me data to understand that changing context (time, weather, quantity of cars) directly affects the effectiveness of the plan and increases the probability that I will not achieve my objectives (being on time and avoiding injury).

Experience teaches me that crossing the road at certain times of day is very difficult because there are too many cars.

 To limit the risk I revise and improve my process by using the footbridge at these times.

I continue to analyse the effectiveness of the processes and revise them when the context changes.  

I also continue to consider innovative opportunities:

  •     can I move the meeting place so that the road does not have to be crossed?
  •    can I change the time of the meeting so that I cross the road when it is quiet?
  •   can we meet electronically?

5. Conclusion

  • risk-based thinking is not new
  • risk-based thinking is something you do already
  • risk-based thinking is continuous
  • risk-based thinking ensures greater knowledge and preparedness
  • risk-based thinking increases the probability of reaching objectives
  • risk-based thinking reduces the probability of poor results
  • risk-based thinking makes prevention a habit