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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
     
     
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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:

TS 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 and effectiveness.

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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…
   
   

Medical devices – Quality management systems requirements

medical pills industry factorMany companies are in the process of upgrading their management systems to include Aerospace and Medical certifications. Registration to these Standards is the key to diversifying your client base.

Management Solutions Group, Inc. has been in the forefront of this effort to provide our clients with assistance in training and implementation. We hope that the following information will be useful as you explore new opportunities in the medical device industry.

This standard is based on ISO 9001: 2000 as are ISO / TS 16949: 2002 and AS 9100 B. Therefore companies that have a strong ISO 9001 or TS 16949 system will find that they have many of the required processes in place. They will still, however, need to address the requirements specific to the medical device industry as required in ISO 13485. We will highlight some of the additional and specific requirements here.

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What is an EMS or ISO 14001 system?

ISO 14001 Man Holding Grass Covered CableMany people immediately think of toxic waste and major pollution sites when they hear of an Environmental Management System (EMS) or ISO 14001. While these items would fall under an EMS, the actual scope is much broader and will affect almost everyone who works within a company with an EMS that meets the ISO 14001 requirements.

What is ISO 14001?

ISO 14001 was released in 1996 with the intent that companies manage all of the activities, products and services that can significantly impact the environment. The Standard has three basic objectives of continuous improvement, regulatory compliance and pollution prevention. The standard is broken into 5 main sections: Environmental Policy, Planning, Implementation & Operation, Checking and Corrective Action, and Management Review. To implement an ISO 14001 conforming EMS a company will have to write and implement approximately 6 new procedures and modify approximately 9 existing procedures (Assuming the company is currently ISO 9000 or QS-9000 compliant)

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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