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Updates to AS9100

Overall Changes and Important Additions from Revision “B” and ISO 9001.

The focus of the AS9100C requirements added to ISO 9001 is on the Aerospace & Defense Industry needs. An important point is that a company currently registered to ISO 9001 that also has automotive requirements such as APQP, FMEA & PPAP built into their system or with staff that is familiar with these requirements will have an easier time upgrading their current system.

Production Process Verification (Basically the “First Article Inspection” FAI) and Work Transfer processes are AS9100 Specific, but companies experienced in PPAP will find that they are quite prepared to meet these requirements.

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Process Mapping in ISO 9001 & TS 16949

ISO 9001: 2000 & IATF 16949: 2002 Process Mapping / Interaction

There is quit a bit of confusion regarding the documentation of the interaction of Processes (Sometimes refered to as Customer Orientated Processes {COP’s}, Manufacturing Orientated Processes {MOP’s} and Support Orientated Processes {SOP’s} required by ISO 9001: 2000 and TS 16949: 2002. Many companies have added additional documents to meet the requirements of documenting the process interactions including “Turtle Documents” and “Line of sight” flow diagrams. While these documents typically assist in meeting the requirements, they usually do not identify process interactions or support processes adequately. Also, and very importantly, they add yet another set of documents that need to be controlled and understood by related staff. However, if done correctly these process interaction diagrams can actually reduce the amount of documentation and increase the effectiveness.

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SEQUENCE AND INTERACTION OF PROCESSES

Section 4.1 (a & b) requires documentation of quality management processes and their “sequence and interaction.”

Now, what does that mean?
Processes have inputs and outputs and are managed by a series of activities. For instance, Verification of Purchased Product, 7.4.3, is a process (dinosaurs who wondered the earth during the ISO9000:1994 era refer to this as receiving inspection). This process has inputs such as supplier evaluation, prints and purchase orders. The outputs may include a receiving inspection log, tags, labels and routers. Activities usually include receiving, inspecting, documenting, identifying and staging.
Where do we start?
First, assign a team that represents all departments.

Next, draw a “sequence of processes flowchart.” This is simply a diagram of the major processes in your system from Quoting to Shipping. This is also called a “line-of-sight diagram.”

Now, diagram the activities associated with each step. Be sure to include all departments in this exercise.

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What is the ISO 9001:2015 standard and what it is not.

What is in ISO 9001:2015 and what is not. Listen to Brandon Kerkstra give a brief overview in this lesson from the online ISO 9001:2015 course.

What ISO 9001:2015 DOES Include   What is NOT in ISO 9001:2015

thumbs up 3 whiteRequires an organization to have the information (documents, procedures, etc.) and records required for effective business planning and implementation

  thumbs down 3 whiteRequiring a change in your document identification system. It is your decision.
thumbs up 3 whiteFocus on Strategic thinking. Language is Context of Organization

  thumbs down 3 whiteDescribing HOW to conduct strategic planning
thumbs up 3 whiteFocus on risk based thinking to be initiated at the strategic level or Context of Organization

  thumbs down 3 whiteRequiring risk assessment, risk management, risk treatment, and use of formal risk tools
thumbs up 3 whiteIt is arranged so all ISO Management systems will be aligned=one system   thumbs down 3 whiteDivergent systems are permitted at this time
     
     
     Click play to listen to brandon
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APQP & FMEA

Revised manuals have been released. Both manuals become effective November 1, 2008. They should be implemented on new programs and programs that are in early development.

While the changes are more evolutionary than revolutionary, it would be a great time to train newer quality, engineering and production staff and / or hold a refresher course.

TS 16949 Background:

IATF 16949, PPAP, and Customer Requirements state that you must perform APQP & FMEA, but since they are reference documents you have more discretion as to “How” you implement the processes. The requirement is that APQP & FMEA processes are effectively implemented – Customer and Company metrics can provide information of Customer Satisfaction, efficiency and effectiveness.

IATF 16949: 2016 requires that Engineering and Quality staff be competent within their areas of responsibility. Additionally the Internal auditors that audit the core tools must also be competent. This may be a good time to refresh or train your staff.

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IATF 16949 - Internal Auditor Training - Course Agenda

This is an excerpt from the Online IATF 16949 Internal Auditor Training Course.  Listen to Brandon Kerkstra describe this extensive online course.

  bullet green arrow 25 Module 1 – Introduction and the Automotive Process Approach with Risk Based Thinking

bullet green arrow 25Module 2 – IATF 16949: 2016 Requirements and Objective Evidence (Including Process Design)

bullet green arrow 25Module 3 – Product Design Requirements (Will Not be applicable to all facilities and organizations)

bullet green arrow 25Module 4 – Auditing the Core Tools

bullet green arrow 25Module 5 – Auditing Customer Specifics

bullet green arrow 25Module 6 – Auditing Basics – ISO 19011, including: understanding how to plan, conduct, report, and close out audit findings, sampling, interviewing etc…
   
   
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We review your requirements, then give you a menu of options to meet your budget and schedule.  MSG helps you determine:
  • Goals and objectives
  • Which certifications or standards are applicable
  • What individuals should be involved to tailor your training
  • A time schedule
  • Resources necessary to ensure a successful program launch

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