Pilgrim Harp is AS9120:2016 and ISO 9001:2015 Certified!

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Pilgrim Harp, located in Avon, Ohio, provides the global and domestic sourcing of components and assemblies, handling every aspect of the sourcing process from beginning to end and ensuring the highest quality levels at all times.  Pilgrim Harp and its manufacturing partners all maintain TS, ISO and/or AS certifications.

As a manufacturing outsourcing company for the healthcare/medical, heavy industrial and aerospace industries Pilgrim Harp is a source for a wide range of products.  For aerospace, their aircraft interior products include: airplane seat legs, seat spreaders, seat backs, seat frames, seat arms, seat arm assemblies, seat tray tables, seat tracks and more.  For this customer base, Pilgrim Harp leadership recognized the need for AS9120B certification – which pertains to Quality Management System (QMS) requirements for Aviation, Space and Defense distributors. This standard includes ISO 9001:2015 QMS requirements.

SimpleQuE consultants, Jen Briese and Jim Lee began working with Pilgrim Harp in 2016 to assess where there were gaps between their current system and the new requirements.  They then worked out a customized action plan and timetable to make implementation simple and sustainable.  End result – certification was achieved in June 2017 with no findings from Eagle Certification Group!  Congratulations to the team at Pilgrim Harp!

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The Benefits of Working with a Management System Consultancy

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Ultimately companies hire a management consultancy firm like simpleQuE to save both time and money. Working with experienced professionals can help businesses achieve their objectives quickly and avoid costly mistakes along the way. And thanks to their specialized knowledge, quality and environmental management consultants can help innovate, improve and enhance organizations at every level.

Businesses of all sizes seeking to outperform their competitors and stay at the top of their industry are increasingly choosing to work with QMS and EMS consultants. When selecting a consultancy, they’re looking for someone who can provide tangible results and a clear return on investment. The best consultant-client relationships are based on clarity and transparency, where both parties have set clear roles and expectations and put in place a system to effectively measure results.

Management consultants help organizations improve their business by analyzing their systems and processes and developing plans to help them improve. Whether it’s preparing for first time certification, upgrading to a new standard, simplifying cumbersome quality systems and documentation, or defining processes and process mapping, simpleQuE can help.

Each management consultancy offers different specializations and simpleQuE’s consultants are proven experts in their respective fields. We bring experience from all sides of the table—third party auditor, business owner, management representative, implementer, facilitator, project manager, etc.—in areas including general manufacturing and service, automotive, aerospace, environmental and safety.

After performing a gap analysis, we offer customized solutions for each client we work with. Our strength is in evaluating and understanding your business and culture to find the solutions that will be most efficient and sustainable over time. We’re known as the consultant that simplifies ISO implementation and maintenance.  And simpleQuE is even ISO 9001:2015 certified – proof that we practice what we preach.

No company is exactly the same, and every company’s needs for certification are unique as well. At simpleQuE, we tailor our approach closely to your specific needs and deliver exactly the consulting, auditing and training services your company requires. Our approach eliminates confusion and ensures your company is investing only in the work that is required for certification. Contact us to see how we can add value to your business!

Stelfast Maintains Their Quality Tradition – Achieves ISO 9001:2015 Certification

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Stelfast is a family owned and operated company, which began operations in 1972 as a small and progressive manufacturer of industrial gears and screw machine products. Seeing the need in the market for a reliable and quality oriented fastener company, Stelfast incorporated in 1976 and today is a leading importer; stocking master distributor of fasteners and specialty parts from Asia, Europe, and South America; and manufacturer of truck and specialty fasteners. With a knowledgeable and dedicated team of employees, Stelfast has expanded to include an automotive division and ten regional distribution centers across North America.

As evidence of their commitment to quality, the Stelfast Quality Control Department, based in Strongsville, OH, is responsible for all of their branches to ensure conformance to customer requirements. The ISO-9001 certified facility includes a Quality Lab with measurement and testing equipment specifically used for fastener inspection and testing.

When it was time to upgrade to ISO 9001:2015, Stelfast turned to simpleQuE consultant, Jen Briese to provide certification support and guidance for implementation and improvements of the quality management system. This included a full system internal audit, in preparation for their external surveillance audit. The end result – Stelfast is now ISO 9001:2015 certified!

The quality department is also responsible for maintaining all suppliers certifications, which are kept on file for customers to meet dimensional, material and mechanical properties as required by specifications and customer requirements. Stelfast Quality also performs internal audits to assure compliance to their own strict quality guidelines. PPAPs are generated to meet both AIAG and customer specific requirements. At Stelfast, customer satisfaction is priority one and the Quality Control Department helps to assure that this happens. Stelfast President, Simmi Sakhuja says, “We have a catch phrase around here: ‘GET IT DONE.’ We do everything we can to support our suppliers and satisfy our customers.”

 

Quality + Certification = Success!

SimpleQuE congratulates the following companies on their successful certification and commitment to quality.

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SimpleQuE (an ISO 9001:2015 certified company) assists organizations with implementation, improvement or transition of these standards by providing customized consulting, training and internal auditing services and solutions. Contact us for more information.

Powder Processing & Technology Transitions to ISO 9001:2015

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Powder Processing & Technology, LLC  has maintained ISO 9001 certification since 1998 and just transitioned to the latest version – ISO 9001:2015.  PPT’s professionals have assisted the top materials technology companies around the world for over 30 years. The company performs process development and contract manufacturing on a wide range of powders, and has a fully equipped pilot plant as well as multiple production areas specializing in spray drying, calcining and firing

PPT uses the formulas and processing parameters provided by their customers and/or develops the formulations and processing parameters of the products produced for customers.  Therefore precise process control is necessary to meet high quality standards. For that reason in 2012, PPT brought in simpleQuE to conduct its quarterly internal audits.  Kenneth Bartelt, President, said,  “PPT is a small technology company which places significant weight on its quality management system and which needs to ensure its valuable and limited technical resources are focused on customer requirements and our ability to deliver results.”

“We consider the quality system to be part of the fabric of our management system and simpleQuE has added a critical component to that system,” added Ken.  “I think that simpleQuE has a practical approach to quality management that is effective and efficient.”  In the case of PPT, the commitment to maintaining quality standards is evident and practiced from the highest level of management to their plant workers.

SimpleQuE matched PPT to auditor/consultant, Don Milinkovich, whose 34 years in the chemical manufacturing business made him the right fit.  “Don is an experienced and personable consultant who has delivered meaningful audits and provided relevant expertise. Our audits have been at the right level of detail and have made a significant contribution to the business. The performance from simpleQuE has been such that the registrar’s representative and auditor has been very complimentary of the service they have performed,” stated Ken regarding the benefits of working with an experienced auditor.  Don also worked with the PPT team to prepare them for a smooth transition to the new standard.

These internal audits have reinforced the objectives of PPT to maintain high levels of service and customer satisfaction while utilizing the principles of ISO 9001 to incorporate continual improvement into their business practices.

IATF 16949:2016 Transition Q & A from IAOB

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Cherie Reiche, program manager for International Automotive Oversight Bureau (IAOB) recently presented at Eagle Certification Group’s June Boot Camp to discuss progress of the IATF 16949 transition and the unique intent behind some of the new requirements.   While no FAQs or SIs have yet been published for IATF 16949:2016, Cherie shared some of the common questions that IAOB and IATF members have received for interpretation and clarification from Certification Body automotive auditors.

Must both ISO 9001:2015 and IATF 16949:2016 be used when conducting audits?
Answer:  Yes, as it states in the IATF 16949 Foreword – Automotive QMS Standard, IATF 16949 is not a stand-alone standard, it must be used in conjunction with ISO 9001:2015.

Will the IATF be granting waivers for those organizations who cannot meet the transition plan timing?
Answer:  No, there are no plans to approve/grant waivers.  If the organization does not complete their transition audit in a timely manner (including allowing time for Non Conformance management and CB certification decision), then the organization will lose their certification.  ISO/TS 16949 certificates are not valid past their expiry or September 14, 2018.

Is IATF 16949, Section 4.4.1.2 related to product safety during manufacturing or final customer product safety concerns?
Answer:  4.4.1.2 was created to address final customer safety concerns (braking systems, airbags, fuel systems, etc.).  If the product (or process) is a safety item on the final product, then the organization has to identify the statutory and regulatory product safety requirements that must be met, along with items a) through m) in 4.4.1.2.  This is one of IATF 16949’s required documented processes, so inputs/outputs, metrics, etc. are required.

Can an organization demonstrate competence only through degrees and certifications for their employees?
Answer:  No, there are multiple ways for an organization to identify training needs and achieving the necessary competence for their personnel.  It is up to the organization to define (and document) training needs, including awareness, and competency requirements for all personnel performing activities that impact conformity to product and process requirements.

What about competency for internal auditors and second party auditors?  Do they all have to take an IATF-sanctioned lead auditor training course?
Answer:  No.  Organizations are responsible for ensuring key personnel, including their auditors, are properly trained and competent.  The IATF supports the use of IATF-recognized training providers; however, the IATF does NOT mandate the use of a lead auditor training course for all auditors in the organization.  Organizations are still allowed to have key personnel trained and certified as lead auditors, and then use those key personnel to train-the-trainer to disseminate the information throughout the organization.

If an organization is not design responsible for the software used in their product, does 8.3.2.3 (embedded software) apply?
Answer:  Section 8.3.2.3 refers to internally developed embedded software, not “functional test” software to see if a widget works (or not) during production.  For those organizations that are design responsible for the software used in their product, they must use a software development assessment methodology to assess their own software development process.  Annex B contains suggested Software Process Assessments such as CMMI or SPICE.

What is the goal of 8.4.2.3?  Do all organizations supplying automotive product have to be IATF 16949 certified?
Answer:  The ultimate objective is to have IATF 16949 certification; however, the IATF recognizes that for various reasons, that is not feasible for all organizations.  At a minimum, the expectation is for organizations to be certified to ISO 9001:2015, unless otherwise authorized by the organization’s customers.  Items a) through e) are a cadence which is applicable to the entire automotive supply base.

How are 8.3.2.3 and 8.4.2.3.1 different?
Answer:  8.3.2.3 refers to the organization itself and their internally developed embedded software. 8.4.2.3.1 refers to the organization’s suppliers of automotive product related software.  The organization needs to ensure that their suppliers of automotive product related software implement and maintain a process for software quality assurance for their products.

SimpleQuE will be sharing more information from IAOB and other Eagle Boot Camp sessions in future posts and on social media.  Follow us on Facebook, LinkedIn and Twitter for the latest quality and certification news.

Look Fors – Part 3: Planning for Risk and Change

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Would you like to know what 3rd party auditors are looking for when auditing how your company complies with quality system standards like ISO 9001:2015?

016_1469JimFLOffice 1What are 3rd party auditors looking for?  This is the third of a three part series by Jim Lee, President of simpleQuE

Clause 6 of ISO 9001:2015 – Planning for Risk and Change
In parts one and two of this series of articles, Context of the Organization and Leadership were covered. Next is the topic of Planning for Risk, which brings risk-based thinking to the forefront. Once the organization has identified the risks and opportunities in Clause 4, it needs to stipulate how to address these.  The planning phase examines who, what, how and when risks must be addressed.  It’s a proactive approach that replaces preventative action and hopefully reduces the need for corrective actions later on.

Particular focus is also placed on the objectives of the management system.  These should be consistent with the quality policy and be measurable, monitored, communicated and updated when needed.  Changes to the QMS should also be planned and consequences understood to assess risk and minimize potential negative impact.

 

Third party auditors may use the following for evidence of risk based thinking and integration into the quality management system:

  • Design reviews
  • Competitive analysis, benchmarking, recall analysis, competitive testing
  • Process control plan, internally tighter tolerances and controls than customer specs
  • Management reviews
  • Process and design FMEA (Failure Mode and Effects Analysis)
  • Corrective Actions, and replicating actions across similar products and processes
  • Metrics related to objective in management review
  • Customer scorecards, dissatisfaction, trends and performance
  • Operational meeting minutes with action items for higher risks
  • Change in leadership or new programs
  • Processes to deal with new technology, new materials, new processes, new products, new suppliers, new packaging, moving production, changing equipment
  • Program plan describing and monitoring change
  • Equipment maintenance plans and programs
  • Calibration frequencies
  • Internal audit frequencies, and the need to audit some areas more than others
  • Contingency plans
  • Strategic or business planning, SWOT (Strength, Weaknesses, Opportunity, Threats) analysis, PEST (Political, Economic, Social and Technological) analysis, etc.
  • Approval for capital, along with the justification and risks to invest now or delay to later
  • Supply chain risk management with supplier performance, financial stability, sole sourcing, geography with lead times and inventory in transit, leverage, long term agreements, etc.

 

Not that all of the elements listed above will be needed, but organizations may experience potential issues if:

  • Risks and opportunities are not identified when there is clear evidence of problems or need for action
  • Risk-based thinking is not driven by leadership
  • Actions to address risks and opportunities are not taken or not effective
  • Risk evaluation is not applied throughout the QMS (supplier selection and evaluation, new product or service, short lead time, capacity constraints, etc.)
  • Measurable objectives are not established
  • Objectives are not monitored or changed as the context of the organization changes
  • Action is not taken when objectives are not met, or trends are going the wrong direction
  • The impact of change is not identified or magnitude of change not understood
  • Costs/schedule are not included in defining change

Also, read more about Context of the Organization in Part 1 and Leadership in Part 2.

 

 

Source:  NQA’s Teaming Conference – August 2017

SimpleQuE’s IATF 16949 Gap Audit Checklist is Now Available!

Innovation concept. Businessman throw a paper plane symbolizing acceleration and innovation.

The automotive quality standard has come a long way since its first inception in 1994.  With the new standard and more than 200 changes, simpleQuE recognized the need for an IATF Gap Audit Checklist to assist companies with the transition. The checklist includes the new automotive requirements (IATF 16949:2016 and ISO 9001:2015) and is intended to be used as a tool to identify both compliance with the new requirements and the differences between ISO/TS 16949:2009 and the new requirements.

The utilization of this checklist, when populated with objective evidence of compliance and non-compliance, will satisfactorily demonstrate you have audited the differences between ISO/TS 16949 standard and the new requirements.  It should be used with your certification body as evidence of internal audits to the new IATF 16949 and ISO 9001:2015 requirements.  It’s one of the methods simpleQuE auditors and consultants use with our own clients.

A free half hour of phone or email consulting with a simpleQuE expert is included with the checklist for the purchase price of $300.

The simpleQuE team wishes you a smooth and simple transition!

Look Fors – Part 1: Context of the Organization

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What are 3rd party auditors looking for?  This is the first of a three part series by Jim Lee, President of simpleQuE

Clause 4 of Annex SL – Context of the Organization

This is the cornerstone of a management system and the business’ strategic direction.  An organization needs to identify internal and external issues that can impact its intended outcomes, as well as all interested parties and their requirements.  It needs to document its scope and set the boundaries of the management system to line up with business objectives.

The context doesn’t have to be documented, so 3rd party auditors (as well as internal auditors) will be asking questions of various management members, and looking for these as objective evidence that an organization understands its context and considers all the factors and stakeholders affecting the business.  The items listed below don’t have to exist, but if they do, you want to take credit for them in understanding the context.  Some items may not by themselves demonstrate an understanding of the context, but combined with multiple examples, can provide the evidence an auditor is looking for.

  • Business plan
  • Strategic plan
  • SWOT analysis (Strengths Weaknesses Opportunities Threats)
  • Vision and mission statement
  • Process mapping
  • External parties identified
  • Lesson learned
  • Surveys
  • Internal meeting minutes to determine company goal setting
  • Metrics to measure effectiveness of QMS
  • Process turtle diagrams
  • Process flow plans
  • Quality manual

Not that all of the elements listed above will be needed, but organizations may risk failure if they do not:

  • Identify or understand their primary competitors
  • Mention civic responsibility
  • Consider future business trends
  • Identify all customer requirements
  • Identify local/state/national requirements
  • Identify required outputs needed for internal customers
  • Identify uncertainties like negative risks or positive opportunities
  • Determine the processes used to flow the business from quote to delivery
  • Identify outsources processes
  • Establish process goals

 

Coming in future articles – what auditors are looking for in regard to Leadership and Risk.

 

Risky Business vs Risk-Intelligent Business

Rolling the dice concept for business risk, chance, good luck or gambling

Digitalization, globalization, competition and the speed of technological advances has changed the nature of business.  ISO 9001:2015 has been in effect for a full year and it places a heavy emphasis on using “risk-based thinking” for managing quality-related processes. Risk has always been implicit in ISO 9001.  But the latest revision asks organizations to make a cultural shift—rather than focusing on isolated problem solving and resolution, they’ll focus on prevention and performance improvement.

The International Organization for Standardisation (ISO) explains it this way:

“Risk based thinking ensures these risks are identified, considered and controlled throughout the design and use of the quality management system”.

Under the new guidelines, risk management serves as the cornerstone of quality management system design. As organizations determine the processes needed for a quality management system, they’re also asked to determine the associated risks and opportunities and to plan and implement appropriate actions to address them.

In the context of ISO, the concept of “risk” relates to the uncertainty in achieving the main objectives of International Standards—namely, to provide confidence in the organization’s ability to consistently provide customers with conforming goods and services, and to enhance customer satisfaction. Risk is the possibility of events or activities preventing an organization from achieving its strategic and operational goals.

This shift in thinking does not replace the standard’s process-oriented approach, but enhances it. While the process is still a critical part of ISO 9001:2015, processes must now be implemented with an acute awareness of risk.

Organizations are asked to identify, analyze and prioritize all potential risks as they undergo building or adapting their existing quality management implementations for updated certification.

Risks can be defined by two parameters—the severity, or seriousness, of the harm, and the probability that the harm will occur. Risks can be assessed based on the likelihood they will occur, the likelihood they can be detected, and potential impact should they occur. From there, risks are evaluated based on their importance (what is acceptable, what is unacceptable?) and actions are planned to address the risks, whether that’s avoiding or eliminating the risk or mitigating it.

Once plans are implemented, it’s essential for organizations to check the effectiveness of their actions and continually learn from experience.

What’s the best way to document risk-based thinking and demonstrate the approach during audits?. Evaluate how you evaluate risks today with the processes you have. Understand how you decide when risks are acceptable or unacceptable.  ISO wants to see that you record identified risks when action is required, and the action steps to be taken. 

Putting into place the Plan-Do-Check-Act (PDCA) methodology can be a great way to define, implement and control corrective actions and improvements. Companies should Plan what to do and how to do it, Do what was planned, Check that things happened according to plan, and Act on how to improve the next time around.

Companies have two years to make the transition to ISO 9001:2015, as certifications for the 2008 edition will expire after September 2018.

SimpleQuE was one of the first consulting companies to be ISO 9001:2015 certified and we’re ready to assist organizations with transition or implementation.  Please visit our website for more information about our services.