How to conduct Failure Mode and Effect Analysis, FMEA

How to conduct Failure Mode and Effect Analysis, FMEA

By Mahmoud Elhefnawi

What is FMEA?


The System FMEA is a team-oriented methodology for minimising the risk of the development and it stimulates the interdisciplinary co-operation between the affected areas already in a very early stage. Furthermore, it provides a documentation of knowledge within the company.

[Read more…]

How to conduct Gauge R&R study: By MIE

How to conduct Gauge R&R study



Satisfying the requirements of ISO TS or any other standard that demanding from your organization to implement Measurement System Analysis, a Gauge R&R ( repeatability and reproduce-ability) study for each inspection process you have has to be carried out and documented.

[Read more…]

Some ISO Definitions



[Read more…]

7 Skills required to establish an excellent SOP, By MIE

7 Skills required to establish an excellent SOP, By MIE


7 skills you have to know to master your capability of writing excellent SOP. Excellent SOP doesn’t mean that you just describe what you are doing, but writing the right thing in the right way.

Doing the right thing, you have to define the right objectives for your process which shall deliver the results that your customer is expecting to receive. This will make you effective.

Doing the process in the right way will make you efficient. The following 7 skills shall make you on the right track of excelling your SOP. [Read more…]

Document control procedure template, By MIE

document control2


This is a simple template for a document control procedure as part of ISO9001 requirments , it can be adopted to suite the organization requirements

A- Objective

this procedure describes the process steps of creating document,  these steps are  writing , reviewing, approving, distribution, updating, disposal


B- Scope

This procedure is applied to all [organization name] departments/ sites

C- Distribution

List all participants in doing actions in this procedure

D- Abbr./Terms

List all abbr. / terms used in this procedure

E- Responsibility

The owner(s) (position) who shall implement this procedure

F- Process description


 Document Types

– Documentation Hierarchy
L1 : Manuals
L2: Procedure , Agreements

L3: Work Instruction , Q-Standard ,Inspection instruction and process Sheet

L4: Form, Inspection Plan , Control Plan , Checklist , Drawing , Material Specs

– Laws / Regulation
• Drawing
• Standards
• Material Specifications

The document may be a hard copy or an electronic media

Document  Issue

Establishing document and data is the responsibility of department head, and according to quality representative recommendations.

The document shall describe  who/why/when/where/ how the document will be implemented.

Document shall mention clearly when the process start, and when it ends.

According to the nature of the operation process, owner shall define the level of details required to be mentioned in the document.

Procedure / Work instruction, inspection instruction should follow the following structure:

  • Objective
  • Scope
  • Distribution
  • Responsibility
  • Abbrv. / Terms
  • Detailed description of the process
  • Supporting Documents
  • References

Coding Of Document
– All documents shall take a unique identification code number. The Code Number for the document is used as a reference to this document.

– Coding the documents is the responsibility of document control.

Review and approval of document

– Owner gets the code for his document from DC
– The respective manager reviews and confirms the document
– Owner sends the confirmed document (hard copy , Soft copy via E-mail) to DC
– DC reviews the structure of the document.
– DC sends the document to QR for final review, and approval .

Distribution of Documents

– DC registers approved documents in the Master Document list, mentioning the version of the document

– Notification email and / or pdf document shall be sent to all users by DC

Document Amendment

– Amendment of the document may be because of change in the process, specification update, or audit requirement for continuous improvement
– All changes shall be implemented by the owner, who established the document. Before any changes are issued, the establisher shall first agree with all concerned departments.
– After changing the document, the steps of issuing the document shall be followed


At any time the owner of the process decided to cancel the working procedure, he shall notify DC with the decision and the proper justification

DC shall inform the concerned parties, and withdraw the cancelled document.


Supporting documents

• Master Document List







Process Capability Applications in ISO 13485 Following ISO/TR 10017 – Webinar By GlobalCompliancePanel by Dan OLeary


cpkwebYou can improve the implementation and effectiveness of your Quality Management System (QMS) by using statistical techniques. The techniques are broadly applicable across the QMS. ISO provides a technical report that explains a number of statistical techniques. The report also lists the QMS where the specific techniques apply.

Why you should attend: Process Capability Analysis (PCA) is a powerful tool used to describe, troubleshoot, and improve (Quality Management System) QMS processes. This webinar will help you understand the concepts of PCA and show you applications in your QMS.

Your Quality Management System (QMS) should be able to address these questions quickly and easily. If not, then your team needs to attend this webinar!

* Do you report process capability indices at your Management Review?
* Do you use PCA and capability indices to help you identify and prioritize improvement activities?
* Have you validated processes and improved them to ensure a Cpk? 1.33?
* Do you use PCA to help evaluate your suppliers and the product and services they provide? [Read more…]