May 9th, 2013 by Aaron Troschinetz
In the course of Management System audits, auditors often find themselves confronted with various LEAN implementations and as a result, trepidation sets in as to the validity of these tool implementations of solid, ‘moving forward’ continual improvement examples (ref. AS9100C, 8.5.1).
It’s interesting to see examples of how LEAN can overcome an organization and peel away at foundational layers of a Management System but in the end, I contend the most effective organizations have LEAN and Management Systems ‘working together’. Imagine for a moment a LEAN implementation without … robust data analysis (ref. AS9100C, 8.4), standardized work instructions (ref. AS9100C, 4.2.3 and 4.2.4), process identification (ref. AS9100C, 4.1 and 8.2.3) and even ‘just fix it’ tools (ref. AS9100C, 8.5.2). It’s hard to imagine, isn’t it? Nonetheless, auditors come across this all the time and we sit there dazed and confused.
Clearly a company that is elevated a LEAN culture within their organization would NOT handle these overlapping tool sets independently and one of the important aspects of a robust internal audit program (ref. AS9100C, 8.2.2) over time is that we look for evidence of how processes are stabilized and requirements are formalized (using a process-approach, appropriate process audit trails). In the end, without this settling with continual improvement and the formalization of tools within a comprehensive Management System, LEAN will need to keep LEAN’ing back in.
Posted in: Aerospace |
April 8th, 2013 by Aaron Troschinetz
AS9104-1 has brought various changes to CB requirements including new clear and explicit ‘flowdown’ requirements from CBs to their clients with items such as client’s provision of audit report information through CB’s management of OASIS, ‘right of access’ with Oversight/ABs during client audits and notification requirements for clients to their customers if suspension/withdrawal of certificate occur. These items are not commercial terms so to ensure they remain preserved and transparent, SAI Global has contained them in one Addendum document.
How does it affect me (client)?
SAI Global clients are encouraged to review these NEW AS9104-1 SAI Global Client Contract Addendum requirements carefully to make sure the appropriate personnel in their organization are aware of what is being required from clients moving forward.
What action do I need to take, if any (client)?
None at this time – this communication is only intended to notify clients that this NEW AS9104-1 SAI Global Client Contract Addendum document is being adopted moving forward with SAI Global work and as a result, this communication is being sent to all clients.
Posted in: Aerospace |
March 12th, 2013 by Aaron Troschinetz
When building an effective overall business management system (and correspondingly quality management system), organizations should pay particular attention to the establishment and attainment of competency requirements with functions deemed detrimental to the performance of their system as well as related to achievement of conformity of product. Competency, as defined as the demonstration of knowledge and skills (ref. ISO 9000:2005, 3.1.6), is a frequent audit trail for auditors to truly test the robustness of a client’s overall system. Auditors will regularly walk through questions such as the following: 1) How does the organization identify the appropriate functions that affect system performance and relate to product conformity?; 2) How are these functions made aware of these competency requirements and how are they defined? and 3) How well are these competency requirements achieved in respect to these functions and does lack of achievement of these competency requirements put at any risk the performance of the system or conformity of product? It’s important to keep in mind that competency is both definition and achievement so organizations should have clear, concise definitions of skills, educational requirements required for a function and then correspondingly be ensuring these items are clearly demonstrated and achieved. As for elaborate tools, software or competency-based processes; there are countless examples of how this concept has moved forward significantly in the marketplace but in the end, no technological solution can help an organization if the homework with identifying the right functions to match the right knowledge and skills has not been done upfront.
ISO 9001 – Quality Management System (QM) Training Course
SAI Global Training Services specializes in a wide variety of training services. Further information on available offerings can be found at: www.saiglobal.com/training/assurance/
Posted in: Aerospace |
February 26th, 2013 by Aaron Troschinetz
As life continues past AS91XX:2009 and now into the new supporting scheme requirements as put forth in AS9104-1, continued discussions are occurring with the concepts and application of Risk Management (ref. AS9110C, 7.2.2) within the overall AS scheme requirements. An important piece for organizations to understand with Risk Management is that there are a series of different, required ‘features’ to having an overall effective, robust Risk Management process: 1) Assignment of responsibility for identification and mitigation of ‘risk’ identified issues; 2) Definition of how ‘risk’ is defined, quantitatively or qualitatively; 3) Identification of how ‘risk’ is defined in particular with product realization processes; 4) Support for the identification and retention of ‘risk’ mitigation actions; and 5) Documentation and authorization for the organization’s acceptance of ‘risk’ in the end which cannot be effectively mitigated or eliminated altogether. In terms of the other piece (application), organizations need to be constantly attentive with supporting Risk Management customer requirements in terms of flow-downs accepted risk management tools and most importantly, contractual obligations from the organization to the customer. For this and further Risk Management discussion, please see the ‘Webinar: Managing Risk within the Aerospace Supply Chain’.
Posted in: Aerospace | Risk Management |
February 13th, 2013 by Aaron Troschinetz
We are very pleased to share with our clients and the overall marketplace that SAI Global has completed its AS9104-1 accreditation process (as of February 4th, 2013). Read more on the accreditation.
Posted in: Aerospace |
January 23rd, 2013 by Aaron Troschinetz
During the course of the 2012 Calendar Year and through July 1st; SAI Global (just as any other CB in the Aerospace Industry Controlled Other Party scheme) was actively engaged with Oversight/ANAB, auditors, internal staff and most importantly, clients with completing the rigors of AS91XX:2009 (Rev C) transitions.
I am pleased to report that SAI Global completed the largest AS91XX:2009 (Rev C) transition of Aerospace clients in the world – on-time and in compliance with all Oversight/ANAB reporting requirements. This was a total team effort from the office to our auditors to our clients working together with new requirements, new audit tools. While transitions of any kind are challenging for everyone, I remain convinced that we as an industry are moving in the ‘right direction’ with process-approach techniques and better application of process effectiveness within the framework of our audits. We certainly all have room for improvement and as such, SAI Global is committed to this realization of improvement by active contribution, participation during Oversight meetings, committees in the appropriate standard, supporting requirement development. We are continuing to look ahead in 2013 Calendar Year with some sense of relief that this AS91XX:2009 (Rev C) transition is no behind us; however, nothing stays still in our industry and as an industry committed to quality, we know there is always improvement that can made ahead.
Next Blog: Aerospace and Risk Management
Posted in: Aerospace |
January 23rd, 2013 by Aaron Troschinetz
Hello, my name is Aaron Troschinetz and I am the Technical Manager – Aerospace for SAI Global. At SAI Global, we are committed to being a market leader in the development and delivery of 3rd party conformity assessments. My particular area of specialty is Aerospace and to promote communications out to the marketplace regarding SAI Global and Aerospace; I’ve teamed up with our Marketing group to put out a blog dedicated to our Aerospace activities here at SAI Global. Roughly once a week or more, I will be posting some information on this blog for everyone’s consideration.
I would encourage anyone with questions, concerns regarding blog postings to contact me appropriately- I can be reached at email@example.com. Thanks for taking the time to read my blog.
Posted in: Aerospace |
October 5th, 2011 by Stacie DeBenedictis
Through the transition process we have found some common pitfalls where organizations are experiencing high numbers of nonconformities. This slows down the transition process due to extensive corrective actions and depending on the severity, on site follow-up prior to certification. Please apply these examples to your own organization in order to maximize your opportunities for improvement.
Some of the areas that are causing delays for organizations are as follows:
- General Requirements (4.1). The intent of AS9100 & AS9101 is for organizations to clearly define processes required for the QMS and show their interaction and sequence. The identified process MUST have measurable objectives that allow the organization to determine effectiveness. Measures of the absence of customer complaints/returns or any other negative indicators are not measures of effectiveness. The status quo in many cases is not going to cut it. Additionally measures of customer on-time delivery and quality are measures of effectiveness of the QMS. The QMS is made up of processes and those processes must be measured for effectiveness. Another aspect that is causing an increase in nonconformities is improvement of processes. Where an objective is not being met, the organization MUST be able to demonstrate improvement activities.
- Risk Management (7.1.2). The requirements for a Risk Management Process are defined in section 7.1.2. The application of Risk Management is defined throughout the standard. Organizations must apply Risk Management for any Special Requirements and/or Critical Items, at the Project Management phase (7.1.1), at the customer quote and contract phase (7.2) and when selecting and using suppliers (7.4.1).
- Supplier Approval Status (7.4.1.a & d). Organizations are now required to define the process, responsibilities and authority for the approval status decision, changes of approval status and conditions for a controlled use of suppliers depending on the supplier’s approval status, and determine and manage risk when using and selecting suppliers. Most organizations had approved suppliers. Very few organizations ever defined the approval status and supporting aspects of the status. Taking a status quo approach here will definitely result in major issues.
- Internal Audits (8.2.2) There has been some misinterpretation that organizations do not have to conduct audits to AS9100C. Here you would simply revert to what the standard states. “The organization shall conduct internal audits at planned intervals to determine whether the quality management system a) conforms to the planned arrangements (see 7.1), to the requirements of this international standard and to the management system requirements established by the organization”. The words ‘this international standard’ mean AS9100C. Organization still conducting internal audits to AS9100B will experience a delay in the transition process because a nonconformity will be written and it will need to be corrected with implemented actions which mean conducting internal audits to AS9100C.
These are the main issues that are causing significant delays. If you have major issues resulting from a transition audit and the auditor requires on-site follow-up before the certificate can be issued, this could possibly delay your certificate as well as result in additional charges. Aerospace auditors are fully booked up and they may not be able to get back to your site for an extended period of time.
On July 1st , 2012 all AS9100B certificates remaining in OASIS will be withdrawn. Organizations that have completed their audit prior to July 1st, 2012 can eventually regain certified status upon completion of any corrective actions and subsequent review by the Certification Decision Group. You will experience a gap in certification and show up as ‘withdrawn’ in OASIS. Organizations who do not have their audit completed by July 1st , 2012 will lose their certification and have to start over from an initial certification audit. The ideal situation is to have your transition audit in advance of the deadline to allow time for the corrective action process and certification review.
Time is running out, but there is still time to address these areas prior to your transition audit so your certificate is not in jeopardy. If you have any concerns, please speak with your lead auditor.
Posted in: Aerospace | Compliance and effectiveness | Risk Management |
September 19th, 2011 by Stacie DeBenedictis
The transition to the AS9100C series of standards as brought a whole new grouping of AS9100 nonconformances. Traditionally, a review of the top areas of nonconformances at any given time for AS9100B would have shown the top 3 issues to include internal audits, corrective action, document control and control of production. Those areas are still resulting in AS9100 nonconformances, however, there has been a big switch in the top 3, as you can see in the chart below, taken from a sample of 50 AS9100C audits that have recently been conducted by SAI Global:
AS9100 Nonconformances from Revision C Audits (2011)
Bar graph of recent AS9100 nonconformances
#1 – General Requirements – Clause 4.1
The number one area for AS9100 nonconformances, by a significant margin, is ‘General Requirements’ clause 4.1. This is due to organizations not adopting a process approach where the processes necessary for the Quality Management System are not clearing identified with interactions and sequences. Another factor for the rise in this area is AS9101 requires that aerospace nonconformances be written whenever a process is deemed ineffective. This is due to organizations not taking action to improve processes when customer and/or internal targets are not met.
#2 – Planning of Product Realization – Clause 7.1
The second main area of AS9100 nonconformances is Planning of Product Realization, clause 7.1. This clause includes, Planning, Project Management, Risk Management, Configuration Management and Control of Work Transfers. There are 3 brand new requirements in this section which have resulted in increased AS9100 nonconformances. Organizations need to really look at this section and ensure each requirement is addressed. The planning section is crucial for an organization to ultimately meet customer delivery and quality requirements. Failure to plan effectively, will almost certainly lead to missed deliveries and/or quality problems.
#3 – Purchasing – 7.4.1
The third section resulting in the most AS9100 nonconformances is the Purchasing Process, or clause 7.4.1. This section incorporates a couple new supply chain management requirements that are resulting in increased audit findings. The first is supplier approval status. Organizations must define their process for supplier approvals and any subsequent changes. The organization must also determine and manage risk when selecting and using suppliers. Supply Chain Management is a hot topic within the aerospace industry and failure to address these new requirements will certainly result in AS9100 nonconformances.
Posted in: Aerospace | Uncategorized |
September 6th, 2011 by Stacie DeBenedictis
AS9100’s Revision C moved the Configuration Management section to clause 7.1.3 – Planning of Product Realization, where it falls in line with Planning, Product Management and Risk Management, and is naturally followed by the “Control of Work Transfers”. Configuration Management is an important part of the product realization process, as it identifies the pedigree of product and any subsequent changes.
Could you REALLY exclude Configuration Management from AS9100 Audits?
As we ramp up AS9100:2009 audits, SAI Global is finding some organizations are attempting to exclude Configuration Management. Their contention is that it now falls under Section 7, so it is permissible for exclusion. Many organizations attempt to cite the fact they are non-design permits this exclusion. The lack of configuration management would certainly affect an organization’s ability to deliver product that meets requirements. It is expected that any organization producing or processing product implement some level of configuration management.
Configuration Management can take on varying degrees of complexity depending on the product. The level of configuration management needed for a complex assembly would be far greater than that of a component. The standard requires ‘The organization shall establish, implement and maintain a configuration management process that includes, as appropriate to the product…’. The key phrase there is ‘as appropriate to the product’. The standard is not prescriptive, but it does require the organization to determine the level configuration management necessary, and establish a process. Organizations can refer to the ISO 10007 Guidance document for help with configuration management. It is best to address the requirement up front before heading into an AS9100:2009 audit. Claiming an unjustified exclusion will result in a nonconformity and hold up the certification process.
Need help understanding what Configuration Management is?
Read our previous blog article on Configuration Management.
Posted in: Aerospace | Compliance and effectiveness |