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AS9100 Manufacturing Objective Evidence

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Quality Management System (QMS)

The overriding theme governing AS9100 manufacturers is that assumptions are not allowed. Due to the inherent risks associated with product malfunctions, nothing can be left to pure "on-the-job training" or “tribal knowledge.” In an AS9100 environment, the requirements for procedural details and work instructions are very clear; production operations shall be executed in such a manner that all personnel have available to them correct and current data. Additionally, this information must oftentimes be supplied to the customer and maintained for the purposes of traceability and objective evidence should a problem occur. The problem that most companies face is that the processes associated with maintaining this level of documentation add hours of non-value added time to the manufacturing process and are quite often the bottleneck that prevents product from being accepted by the customer or leaving the loading dock on time. 

AS 9100 Implementation

Sequence Enterprise offers military and aerospace manufacturers the ability to efficiently and cost-effectively manage manufacturing work instructions in a rigorous, version controlled environment. With integration to ERP, work instructions can be versioned to specific work orders / serial numbers providing complete traceability for any build.  Electronic delivery of work instructions to the shop floor and capture of information against the work order provides detailed records of what, when, where, how and by who a product was assembled. military_5

Maintain Objective Evidence

Additionally, gone will be the days of gathering paper manufacturing documents for objective evidence and customer audits.  Using a standard database reporting tool allows all of the information captured during the manufacturing process to be easily compiled into a production record book /  production audit book for every completed work order.  All of this comes at a fraction of the cost of maintaining the same information in a paper-based environment.

If you would like to learn more about our products we invite you to either download a trial of our LockStep Desktop software or get in touch with us to learn more about Sequence Enterprise .

 

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Error Proofing and Standardized Work Instructions

Work Instructions on the Shop Floor

Error-proofing

While we would like to think otherwise, all humans involved in the manufacturing process make errors leading to product defects.  While it isn’t possible to eliminate all errors from tasks performed by humans, the Poka-Yoke philosophy introduce by Shigeo Shingo (2) is focused on “error-proofing” processes using methods to avoid simple human error.

While there are any number of successful methods and guides that have been devised for preventing human error, one important tool that has been shown to help mitigate a number of different causes of mistakes (errors made by novice employees, errors made due to process changes, errors made due to forgetfulness and infrequency of task performance) is Standardized Work Instructions (SWIs). SWIs are instructions designed to ensure that processes are consistent, timely and repeatable. SWIs, especially Visual Work Instructions, support consistent optimal processing by every operator and, provide a convenient way for supervisors to check the operators’ actions. Without the SWI, the operators and their supervisors must rely on collective memory to continue performing a process in an optimal fashion.  (3)

Quality Standard WorkOften the SWI are printed and posted near the operator’s work station. The goals and actual results of using SWI are improvements in: (3)

  • Quality of the finished product
  • Consistency of the finished product
  • Throughput of the process
  • Safety of the operator

 

Work Instructions & Quality

Work Instructions are also used as a key tool in developing the product and standard processes from concept to production, control and quality planning  For compliance and consistent Quality, accurate, available Work Instructions are a critical part of implementing  Error Proofing, Mistake Proofing, and Fail Safe techniques, often used to meet QS-9000 requirements and Quality Improvement initiatives.   Work Instructions with the proper versioning and approval control, become significant in diagnosing problems down to root cause analysis during FMEA (Failure Mode and Effects Analysis), corrective action and preventative activities.

Writing Work Instructions

Finally,  Standardized Work Instructions should be designed to create  the manufacturing process of record for customer, quality and regulatory compliance needs.  They shouldn’t be written behind a desk by an engineer who has never seen the manufacturing floor or process. (4) Rather, the most effective instructions come from documenting the current manufacturing process on line with a wider focus and input from Quality.

Standard Work

Using functionally-specific software like LockStep or Sequence Enterprise allows appropriate manufacturing content to be captured and deployed 90% faster.  Both LockStep and Sequence were designed exclusively to simplify shop floor knowledge capture and transform that knowledge into effective work instructions.   If you are thinking about getting started with Standardized Work or are struggling with your current method of controlling your Standardized Work documents, we would welcome the opportunity to talk with you about how either LockStep or Sequence Enterprise can greatly reduce the time required for creation, revision management and deployment. To learn more, simply send us an email ( This e-mail address is being protected from spambots. You need JavaScript enabled to view it ) or fill out the request more information form and let us know how we can help.

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References­­­­­­­­­­­­

  1. Poka-Yoke, Nikkon Kogyo Shimbun, Productivity Press, 1988.
  2. Zero Quality Control: Source Inspection and the Poka-Yoke System, Shigeo Shingo, Productivity Press, 1986.
  3. http://trainingwithinindustry.blogspot.com/2010/03/dont-write-work-instructions.html
  4. http://world-class-manufacturing.com/Lean/swi.html

 

A Note on "The Checklist Manifesto – How to Get Things Right"

Note to Managers and Engineers … Has anyone else read the book “The Checklist Manifesto – How to Get Things Right” by Atul Gawande?

I found it very thought-provoking and promotes one to think about instructions in many ways.   Here’s an excerpt of the introduction that got me hooked to read the book.  “The modern world has given us stupendous know-how.  Yet, avoidable failures continue to plague us.  And, the reason is simple:  the volume and complexity of knowledge today has exceeded our ability as individuals to properly deliver it to people --- consistently, correctly, safely.  We train longer, specialize more, use ever advancing technologies, and still we fail.”    So very true!

The author is a physician and describes the use and value of checklists and instructions in many industries including medical.  There are really interesting stories about the early days of aircraft building with Martin, Douglas and Boeing as well as the master builders of US Capitol buildings, Notre Dame and St. Peter’s Basilica, with examples on the importance and use of check lists.   Stories of current manufacturers and large corporations such as Coca-Cola are referenced on the importance of automation and computer technology while still focusing on the need for simple instructions, often in the form of a check list, instructions or controlled work flow.  This is an enjoyable book with a variety of scenarios that will inspire creative thinking about the intent and deployment of instructions in your work environment today.

If you have read this book, please give us your comments.   If you want more information or wish to discuss this further, give me a call.  I’d love to hear from you.

Contributed by Marlene Eeg

President

Tempo Resources, Inc.

Toll free 877.207.3801

FFD Content Goes Live at AS9100 Store

FFD is pleased to partner with the AS9100 Store to expand its marketing efforts to the military and aerospace industries.  Military & Aerospace manufacturers , particularly those subject to AS9100 regulation, work under some of the most demanding oversight and documentation requirements of any industry.  Sequence Enterprise offers military and aerospace manufacturers the ability to efficiently and cost-effectively manage manufacturing work instructions in a rigorous, version controlled environment.  With integration to ERP, work instructions can be tied to specific work orders / serial numbers providing complete traceability for any build.  Electronic delivery of work instructions to the shop floor and capture of information against the work order provides detailed records of what, when, where, how and by who a product was assembled.  All of this comes at a fraction of the cost of maintaining the same information in an “Office” or paper-based environment.

Work Instruction Discussion Forums

Over the course of the last week I took the time to go back and review a couple of my favorite discussion boards related to work instructions - www.eng-tips.com and www.elsmar.com . I was amazed at the number and depth of threads dealing with real-world issues surrounding work instructions (WIs). I found threads on topics ranging from formatting for experts and novices to whether or not it is acceptable for shop-floor workers to make notes and annotations on instructions or tabs for personal use. In all instances, the responses were well thought out, on point and clearly intended to provide help to the person asking for help or advice. More than anything, it showed me just how many people, groups and companies are dealing with this every day. I just wanted to take a moment to share these links with our website guests as I believe they are a great resource for anyone involved in the development, management and deployment of work instructions.

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