The 2019 Quarter 4 Impact newsletter includes information on updates to standards and industry news. This issue contains articles on
The Aviation, Space, and Defense Industry is in the process of creating a new revision of the AS9104/1 standard. The AS9104/1 standard is the standard that defines the requirements of Quality Management Systems for Certification Program. You might recognize this standard from your certificate. All AS9100, AS9110, and AS9120 certificates are required to include a reference to the audits being performed in accordance with these requirements.
The standard is currently in a coordination draft phase in which the initial thoughts are submitted to the standards writing community for inputs. In this initial draft, there are a few changes that will be most noticeable for certified organizations. Please note that these are just proposals at this time and are subject to change as the standard goes through the approval process. We do want to share what is being proposed with you however, so you are aware of the potential changes as soon as possible.
Some of the significant proposed changes include:
• The 5 structures of Single Site, Campus, Several Site, Multiple Site, and Complex would go away. They would be replaced with the 2 structures (single site and several site) that are currently defined in ISO 17021 that other industries use.
• A risk assessment would be required to be performed prior to determining the audit days for each audit. This would require a lot of the same information being provided today prior to the audit for planning with some new items. This means the information would be needed more at the time that we have been sending out the AS BD. I expect that we will see the pre-audit process being revamped to support the changes that the industry will be making.
• Audit duration calculations will be more inclusive and flexible at what site the time will be spent at if there is more than 1 site. Audit planning and report writing will now be included in the audit time. Non-applicable processes will result in audit time duration reductions from the minimum baseline.
• Organizations will be required to identify supporting standards that are implemented/required within their organization
The current plan is for the new standard to be published in the second quarter of 2020 with an implementation to follow. It would most likely be 2021 before the Accreditation Bodies and Certification Bodies have transitioned to the new standard and would then be ready to service the Certified Organizations.
On a separate note, the industry asked that we remind everyone that the auditors have the right to change an audit plan at any time during the audit and are expected to make these changes based on information obtained while on-site performing the audit. We understand and appreciate the efforts that our customers go through to make sure that the appropriate individuals are available during an audit and do our best to follow the agenda. When there is information that is presented that creates an audit path that needs to be explored, please understand if changes must be made to explore the audit path.
By: Michelle Barton, Director - Aerospace
Orbus Exhibit & Display Group®, a manufacturer and trade only supplier of portable and custom modular exhibits, display products and graphic solutions, has made its environmental impact a top priority over the years and continues to push to work harder to minimize its impact and reduce its carbon footprint. In 2018, Orbus set and exceeded its environmental goals by recycling and diverting 90% of its total waste from landfills. It is on track to do the same in 2019.
Orbus’ company mission includes a focus on environmental protection and serves as a constant motivator to drive the team effort. “Orbus’ core values are the heart of the company. We strive for and encourage excellence, uncompromised integrity, fiduciary conservativeness and recognize/reward employee and company achievements. We provide a focused, fun work atmosphere and strive to do the utmost to protect the environment!”
In order to reach the 90% waste-to-landfill diversion rate in 2018, Orbus worked with its wood skid supplier to come up with a recycling plan, ultimately turning the pallets into mulch and animal bedding. With help from the ISO Management Review team, Orbus continuously evaluates the recycling program in place to determine ways to increase efficiency, reduce waste and improve processes. There are methods in place for recycling aluminum, cardboard and paper, wood and fabric scraps. Scrap fabric is sent to a waste-to-energy operation or donated to charity where it is repurposed.
“One small idea that made a big difference was simply placing waste and recycle bins as close to our machine operators as possible,” said Jim Concannon, Orbus Operations Manager and ISO Representative. Bins are made available throughout the facility and are labeled and color-coded to show recyclable designation, making it as easy as possible for employees to recycle.
Orbus currently holds two ISO Certifications, ISO 9001:2015 for Quality Management and ISO 14001:2015 for Environmental Management. ISO 9001 pushes Orbus to be more efficient in its manufacturing process and provide distributors the highest quality of display products, graphics and services in the industry. ISO 14001 pushes Orbus to be aware of its environmental impact – its two operations have and to work together to limit the impact they have. These certifications are unique to Orbus and set it head-and-shoulders above the competition. Employees undergo continued training on ISO standards and Lean practices to make sure they are a part of the team effort. It is hard for one person to see areas of improvement throughout a company of this size and it takes a dedicated team to advance the way that Orbus does.
In addition to continued internal review, Orbus makes it a practice to look to other experts for advice on how to improve. Orbus utilizes the knowledge gained about operations and works with various vendors for process optimizations and best practices. With environmental protection as a part of the company’s mission and objective, Orbus’ partners, vendors and competitors can be sure to see continued improvement in operations, efficiency and limiting environmental impact moving forward.
Engineered Controls International (ECI) was recently recognized for 25 years of partnership with DQS for ISO 9001. ECI is the parent company of RegO® and three other major brands.
RegO, which is a 112-year-old company, is a leading provider of valves and controls for the propane, liquefied natural gas, and cryogenic gases industries.
“RegO is built on a history of quality,” said George McGonagle, Vice President of Quality for RegO. “Our 10 year warranty is the greatest in the industry.”
According to McGonagle, the ISO 9001 certification really supports that 10 year warranty. By having consistency in the process and materials, it allows them to continue their manufacturing base.
RegO products are made in the USA,. According to McGonagle, that’s something the customer base really cares about.
The company recently announced a multi-million dollar expansion of its US manufacturing capacity at their Whitsett, NC facility. They will upgrade several of their machining work centers with state-of-the-art equipment that will enhance operational efficiency and significantly increase machine throughput across its manufacturing process.
The long-term ISO 9001 certification is a great achievement, but it also supports the company’s values.
“Emphasis on safety and reliability is important to us,” said McGonagle. “It’s the culture of the company.”
The Aviation, Space, and Defense industry released a new revision to the IAQG OPMT ICOP Resolution Log in October. If you are an active user of OASIS, you may recall receiving a notice about this revision. In this revision, there is a new resolution, Resolution 155. Resolution 155 addresses how audits are to be conducted if the Aerospace series certificate (AS9100 or AS9120) and the ISO 9001 certificates do not have the same scopes of certification.
In regards to this, the resolution states:
For AQMS audits, where there is a difference between an organization’s 9100 series and ISO 9001 scope (scope of certification or scope of the audit, technical or geographic), the CB shall:
• Calculate the audit duration for the 9100 series using 9104-001:2012/2013 clause 8.2 and Table 2 and allocate this duration to the 9100 series scope;
• Separately calculate the audit duration for ISO 9001 and allocate this duration to the 9001 scope;
• Utilize separate reporting (e.g., 9101 used for the 9100 series audit and CB forms for ISO 9001 audit); and
• Issue 9100 series certificate with the associated scope, but do not include reference to ISO 9001 nor the ISO 9001 scope.
For those companies who are impacted by this and only have an AS9100 or AS9120 certificate and an ISO 9001 certificate, there are two typical options. First option is to have the scope the same for both the AS9100 certificate as well as the ISO 9001 certificate. This would require applying the AS requirements to the whole scope that ISO 9001 is also applied to. The second option would be to have two separate audits. One for AS9100 and one for ISO 9001. The days for these audits would be conducted as required by the new resolution.
For those companies that are AS9120 and have an ISO 9001 certificate that includes value added activities, another option would be to change to AS9100 and then the ISO 9001 certificate could be aligned with the AS9100 certificate if all AS9100 requirements are applied to the value add activities also.
For those companies who are certified to other quality management standards, there is also an option that your ISO 9001 certificate could be tied to your certification for another standard. For example, if a company is certified to AS9100 and IATF 16949, the ISO certificate could be tied to the IATF certificate instead of the AS9100 certificate and have the ISO 9001 portion assessed during the IATF audit.
This resolution becomes effective on May 14, 2020 for those that are currently certified and immediately for anyone seeking AS9100 or AS9120 certification. As such, we will not be able to do combined AS9100/AS9120 audits and ISO 9001 audits unless the scopes are the same as of this date.
We are currently in the process of reviewing the certificates of all of our customers that are certified to AS9100 and AS9120 to identify everyone who is impacted by this new resolution. We will be reaching out to those that are impacted to discuss the options and determine the best path forward for each company.
By: Michelle Barton, Director - Aerospace
Even though as a system Design for Manufacturing/Design for Assembly (DFMA) has been evolving in industry for well over a decade now, the evidence suggests that only a few organizations have achieved significant benefit from systemic application and use. While the emerging ideology arose in 1970’s, it only took real shape as a system in the 1980’s when Geoffrey Boothroyd provided what had been basically conceptual with substantial form and structure by incorporating specific tools and methods.
In this article we discuss how DFMA can be of substantial benefit to organizations, and how implementation of the process can be effectively planned and executed.
The concept “Design” is often misunderstood or misconstrued. While some in the field would say “design must be strong enough to be robust,” and others insist it must be “conceptually strong,” somehow the results always seem to involve complexities that challenge efficient and capable realization.
Design has been described as “the art of transforming the customer / user requirements into product specifications.”
Ideally, Innovation and Engineering converge during the Design Process to provide maximum value to the customer. The more the designer understands the requirements of the product, the more the design will be close to achieving a robust solution. A robust design can be characterized, perhaps, as the “Simplest Design,” where Simple means:
• Easy to manufacture & assemble
• Not compromising on functionality
• User friendly
• Cost effective / economical to produce (high value)
Simplicity should be a paramount goal for design. Without it, the product will lack competitive advantage in the marketplace due, at least in part, due to the risk of high costs for manufacturing and assembly.
Nonetheless, simplicity of design cannot sacrifice function. Functional requirements are the key inputs for successful design, not just to meet customer requirements, but to do so by accomplishing a robust design solution.
Omnex strongly recommends the concurrent, cooperative engineering approach, integrating product & process design and incorporating improvement initiatives with FMEAs. By the same token, DFMA needs to be incorporated for enabling simple, cost effective and robust designs for both the product and the production processes. overhaul facilities and the maintenance repair for the aircraft industry at all levels of the MRO (Maintenance, Repair & Overhaul) process.
Although the most common acronym is DFMA, Design for Assembly (DFA) is performed first, followed by Design for Manufacturing (DFM) next, because DFA helps to optimize the assembly design and ideally reduces the number of sub-assemblies / components and their complexity from the perspective of the assembly process. Once the part count is reduced / optimized, then DFM focuses on selecting suitable manufacturing processes and optimizing component / part designs which are optimally producible.
Starting with the functional inputs from the FMEA process, a cross functional, multidisciplinary team is assigned responsibility for DFMA, starting with the three phases of the DFA process:
• First phase - design simplicity in general
• Second phase - to evaluation and optimize the design
• Third phase - optimizing the design for the specific assembly process
Phase 1 is used to question the concept design and to optimize it, so that general design errors are avoided. This helps bring basic initial simplicity to the design. In Phase 1, 10 General Design Rules are used to evaluate the concept.
Phase 2 is focused on optimizing the design by evaluating its design efficiency. A Design Efficiency calculation developed by Boothroyd & Dewhurst provides a relatively simple and effective tool to evaluate the relative efficiency of the design. The DFMA Team’s effort should result in improvements to design efficiency by applying Design Rules.
3 common methods for evaluating design efficiency:
• Boothroyd Dewhurst Technique (mostly widely used)
• Lucas DFA Method
• Hitachi Assembly Evaluation Method
Phase 3 involves choosing the assembly process(es) based primarily on considerations of production volumes and throughput rates required to ensure meeting customer and program requirements. Choices can be Manual, Robotic or Hard Automation assembly processes, or some combination thereof. The DFMA team should impart more knowledge, experience and efforts in each phase of DFA, to enable fewer iterations of Design improvements at the concept.
With a finalized Assembly Design, the team initiates DFM to enhance design robustness.
DFM guidelines are often well defined conditions / recommendations, by process technology, associated with dimensional / part-topographical requirements suitable for specific raw materials, and for the various features/characteristics of the detail part / component. These guidelines have been established (and generally followed) to enhance the manufacturability of individual parts, and to reduce the defects due to part design.
The team chooses the appropriate manufacturing process for each part based on the design outcome from DFA. For each of the manufacturing processes, DFM guidelines are applied to optimize the manufacturability of the design. These guidelines are also employed in verifying the part design before initiating tooling fabrication. If any product design modifications are required based on these guidelines, the DFMA cycle should be repeated.
Once optimized for the manufacturing process(es), the part design is ready for producing the detailed Product Definition (3D model, 2D CAD, print). In this stage the DFMA Team should apply GD&T concepts and Tolerance Stack-up Analyses to further optimize the robustness of the design. The final outcome will be prints for production, incorporating a design result optimized through the use of the DFMA approach.
Benefits of implementing DFM DFA:
1) Product design becomes simpler, with fewer parts, and easy assembly methods
2) Product design incorporates simple error-proofing solutions like asymmetrical mating parts, assured orientation features, auto alignment features, elimination of “blind” assembly tasks, etc.
3) Best assembly sequence is established
4) Design is optimized for the selected assembly method
5) Design is optimized for the parameters of the selected manufacturing process as a process driven activity, and to implement the process by following these steps:
• Assign a DFMA champion at the Corporate Leadership Team level
• Form teams at various levels, e.g. product groups / plants
• Ensure the competency of the teams in employing these approaches
• Identify the commodity / product for performing initial application of DFMA
• Assign each project team with a product / assembly
• Start with Design FMEA, and close the 1st level gaps in design process
• Using the input from Design FMEA, start with DFMA
• Conduct evaluation of progress after every stage of DFMA
• Evaluate the results achieved by each project team. Achieving even a modest 3-4% improvement is a good start
• Implement recommendations and verify the results achieved
• Start the next cycle
To achieve maximum gain from DFMA, Omnex recommends the initiative be adopted as a corporate strategy rather than
This DFMA article has been submitted by Omnex, republished from their own original newsletter. Omnex is an international consulting, training and software development organization that specializes in management systems.
The article was written by G. Mani, Senior Consultant for Omnex, and S. Prabhu, Principle Consultant for Omnex India.
RC 14001® is a Responsible Care management system that encompasses all of the requirements of the ISO 14001 Standard, but goes further to include health and safety, security, transportation, outreach, emergency response and other Responsible Care® requirements.
Traditionally, a company who achieves RC 14001® registration, upon request, can be issued an ISO 14001 certificate as well. Generally, the two standards will appear side by side on one certificate, but in some cases, where the customer requests it, separate certificates will be issued.
The question recently came up as to whether the two scopes can differ. While there is no specific guidance on this, DQS has reviewed and adopted a general stance on whether this should be acceptable. For RC 14001® and ISO 14001, the scopes shall be aligned with the exception of the “preamble”. (DQS RC 14001 certificates start with the “preamble” – “The environmental, health, safety, security and Responsible Care activities and supporting processes associated with…xxx” and DQS Inc. ISO 14001 preamble is “The environmental activities and supporting processes associated with… xxx“. Note that the “preamble” can be different across accreditation bodies. (i.e. DAkkS vs ANAB) This is acceptable.
With the exception of the preamble, the scopes should be identical. Whereas in other standards, for example, ISO 9001, when viewed as a subordinate scope to other programs, such as TL 9001, a company may limited their scope to certain product lines or activities due to business needs.
For Responsible Care® and ISO 14001, the intent is not to exclude activities or products, but rather to define the scope and boundaries of the site. This is further supported in clarification published by ISO.org which states, relating to 4.3…“Scope” of the EMS includes the organization’s functions, physical boundaries, and its activities, products and services to which ISO 14001 requirements will apply. It is common practice to consider the items described in the bullet points when establishing scope statements.
The long standing consensus position to allow organizations to phase-in EMS implementation was confirmed and preserved by ISO/TC 207/SC 1/WG 5 in the 2015 version of ISO 14001. To address the concern that some might “cherry-pick” activities, products and services to purposefully exclude those with significant environmental aspects, a requirement to make the scope available to interested parties was added to ensure transparency, and avoid misunderstanding.
Once the scope and boundaries of the EMS have been defined, no exclusion of activities, products or services within the defined scope is permitted. While an organization retains the freedom and flexibility to determine the boundaries of its scope, its conformance to ISO 14001:2015 should be based on a robust, credible and reliable EMS.
The American Chemistry Council has confirmed that this is the intent as well for RC 14001®, and therefore, DQS Inc will take the general stance that where a site wishes to have an ISO 14001 cert issued in conjunction with his RC 14001® certificate, the scopes must be aligned as described earlier in this document. If the client should wish to request an exception, a documented explanation for the deviation shall be reviewed and evaluated by DQS Inc management.
By: Candace Orbaugh, Director - Sustainability
Sara Gulo is the Marketing Specialist for DQS Inc. in the USA. She's been with DQS for 10 years in various roles, including Verification and Customer Service Professional.
