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!
Aviation Suppliers Association (ASA) promotes safety, regulatory compliance and ethical business practices among aviation parts suppliers throughout the aviation community. Jim Lee is a presenter and attending the ASA Annual Conference and shares news about important changes to the standard.
The ASA-100 standard is going through a revision that will require all accredited companies to add to their quality manuals. The standard and checklist will be released October 1, 2017 and all audits afterJanuary 1, 2018 must be completed to the new 4.1 version.
- One of the changes requires that quality manuals or specific procedures contain requirements for drop shipments direct from a supplier to a customer, bypassing the distributor who sold the part.
- Another change follows ISO and requires that suspect and non-conforming material be addressed in a procedure. Material is to be segregated. If non-conforming material is shipped, the customer must be notified timely.
- All changes to the quality manual must be submitted to ASA by 1/1/2018.
Over 300 companies have received accreditation to the ASA-100 Quality System Standard and FAA Advisory Circular 00-56 since 1996.
Aviation Suppliers Association (ASA) is a not-for-profit association that represents over 600 worldwide member companies that lead critical logistics programs, purchasing efforts, and distribution of aircraft parts globally.
The 2017 ASA Annual Conference takes place July 9-11 in Reston, VA; and is one of the largest for the aviation distributor industry. The event draws aviation professionals worldwide with a range of business development and management, quality assurance, legal/regulatory and general industry topics. The itinerary includes general sessions, workshops, exhibitors, and networking events. SimpleQuE founder Jim Lee presented at the conference on Monday, July 10 about risk management requirements for distributors that are ISO and/or AS certified.
“This is our second year to present on 3 different topics.” said Lee. “We appreciate this opportunity to network with our clients and aircraft parts distributors. Last year we had three simpleQuE attendees at the conference, and this year two. By attending these conferences, we get a lot of information and value that we share with our consulting clients and other staff members.”
Aviation Suppliers Association promotes safety, regulatory compliance and ethical business practices among aviation parts suppliers throughout the aviation community. Over 300 companies have received accreditation to the ASA-100 Quality System Standard and FAA Advisory Circular 00-56 since 1996. ASA Certification Body also certifies companies to ISO 9001, AS9120, AS9100, and AS9110.
By Jim Lee, President simpleQuE
Companies typically have some type of flow diagram showing their interaction of processes. This is the most common method to demonstrate compliance with the process requirements in ISO 9001:2015 clause 4.4 or ISO 9001:2008 clause 4.1. The new standard emphasizes the need to determine inputs and outputs, along with the sequence and interaction of these processes.
For larger companies with multiple sites and headquarters, or parent companies whether domestic or international, a new complexity arises. Registrars are targeting more detail on the linkages, interactions and inputs from sister sites and parent companies, even though those locations may be out of the certification scope. For automotive (TS and IATF 16949) it is not permitted to exclude any related support function no matter where it is performed, remote or on-site. The process map must clearly indicate these interactions.
For ISO 9001 and AS standards we are observing more emphasis by certification body auditors to scrutinize the interaction of process maps to ensure there is adequate clarity of the linkages and interactions, including headquarters that might be out of the certification scope. We are sharing this information as we see more creeping of scope from other standards, and the interpretations of related risks associated with process interactions between sister sites and headquarters. It makes sense since they can be a source of past and current problems due to a quality system breakdown between these sites.
Clients are addressing this by showing the related bodies on their interaction of process maps, and using color coding or symbols with legends to show what is out of the certification scope and what is in. This is part of a company’s context. Consider a situation where ABC Company has a Japanese parent company that is outside its certification scope, but interaction with the parent company can have a significant impact on its core processes in ABC’s interaction of process map. Some companies treat these interactions through the purchasing process, and that is explained as part of their company’s context.
While process mapping is often the first step to process improvement, make sure you are also looking at the bigger picture to understand what influences process performance. For more information about implementing or improving your quality management system, contact simpleQuE.
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
- 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.