How to conduct Failure Mode and Effect Analysis, FMEA

How to conduct Failure Mode and Effect Analysis, FMEA

By Mahmoud Elhefnawi

What is FMEA?

20120731_floodgates

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.

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ISO 9001:2008 requirements , By MIE

qms3This is an overview of ISO 9001:2008 requirments, no details mentioned here, and the contents starts with section 4, other parts are not included here

4.GENERAL REQUIREMENTS

 

4.1 DEVELOP YOUR QUALITY MANAGEMENT SYSTEM (QMS)

 

Establish your organization’s process-based QMS.

 

Document your organization’s process-based QMS.

 

Implement your organization’s process-based QMS.

 

Maintain your organization’s process-based QMS.

 

Improve your organization’s process-based QMS.

 

4.2. DOCUMENT YOUR QUALITY MANAGEMENT SYSTEM (QMS)

4.2.1 MANAGE QUALITY MANAGEMENT SYSTEM DOCUMENTS

 

Develop documents for your organization’s QMS.

 

Make sure that your organization’s QMS documents respect and reflect what you do and how you do it.

 

4.2.2 PREPARE QUALITY MANAGEMENT SYSTEM MANUAL

 

Establish a quality manual for your organization.

 

Maintain your organization’s quality manual.

 

4.2.3 CONTROL QUALITY MANAGEMENT SYSTEM DOCUMENTS

 

Control your organization’s QMS documents.

 

Control documents that are used as QMS records.

 

4.2.4 ESTABLISH QUALITY MANAGEMENT SYSTEM RECORDS

 

Establish your organization’s QMS records.

 

Establish a procedure to control your QMS records.

 

 

5.

MANAGEMENT

REQUIREMENTS

 

5.1 SHOW YOUR COMMITMENT TO QUALITY

 

Support the development of your organization’s QMS.

 

Support the implementation of your organization’s QMS.

 

Support efforts to continually improve the effectiveness of your organization’s QMS.

 

 

 

5.2 FOCUS ON YOUR CUSTOMERS

 

Enhance customer satisfaction by ensuring that customer requirements are being identified.

 

Enhance customer satisfaction by ensuring that customer requirements are being met.

 

 

 

5.3 SUPPORT YOUR QUALITY POLICY

 

Ensure that your policy serves its purpose.

 

Ensure that your quality policy makes it clear that requirements must be met.

 

Ensure that your quality policy makes a commitment to continually improve the effectiveness of your QMS.

 

Ensure that your quality policy supports your organization’s quality objectives.

 

Ensure that your quality policy is communicated and discussed throughout your organization.

 

Ensure that your quality policy is periodically reviewed to make sure that it is still suitable.

 

 

 

5.4 CARRY OUT YOUR QMS PLANNING

 

5.4.1 ESTABLISH QUALITY OBJECTIVES

 

Support the establishment of quality objectives.

 

Establish quality objectives for your organization.

 

Make sure that your quality objectives are effective.

 

5.4.2 PLAN QUALITY MANAGEMENT SYSTEM (QMS)

 

Plan the establishment of your QMS.

 

Plan the documentation of your QMS.

 

Plan the implementation of your QMS.

 

Plan the maintenance of your QMS.

 

Plan the continual improvement of your QMS.

 

 

 

5.5 ALLOCATE QMS RESPONSIBILITY AND AUTHORITY

 

5.5.1 DEFINE RESPONSIBILITIES AND AUTHORITIES

 

Ensure that your organization’s QMS responsibilities and authorities are defined.

 

Ensure that QMS responsibilities and authorities are communicated throughout your organization.

 

5.5.2 CREATE MANAGEMENT REPRESENTATIVE ROLE

 

Appoint a member of your organization’s management to oversee your QMS.

 

Give your management representative authority over and responsibility for your organization’s QMS.

 

5.5.3 SUPPORT INTERNAL COMMUNICATION

 

Ensure that appropriate communication processes are established within your organization.

 

Ensure that internal communication actually occurs.

 

 

 

5.6 PERFORM QMS MANAGEMENT REVIEWS

 

5.6.1 REVIEW QUALITY MANAGEMENT SYSTEM (QMS)

 

Carry out management reviews of your organization’s QMS at planned intervals.

 

Evaluate improvement opportunities.

 

Assess the need to make changes.

 

Maintain a record of your management reviews.

 

5.6.2 EXAMINE MANAGEMENT REVIEW INPUTS

 

Examine information about your QMS (inputs).

 

5.6.3 GENERATE MANAGEMENT REVIEW OUTPUTS

 

Generate management review decisions and actions to improve your organization.

 

Generate management review decisions and actions to change your general quality orientation.

 

Generate management review decisions and actions to address resource needs.

 

 

6.

RESOURCE

REQUIREMENTS

 

6.1 PROVIDE REQUIRED QMS RESOURCES

 

Identify the resources that your QMS needs.

 

Provide the resources that your QMS needs.

 

 

 

6.2 PROVIDE COMPETENT QMS PERSONNEL

 

6.2.1 ENSURE THE COMPETENCE OF WORKERS

 

Ensure the competence of anyone within your QMS who could directly or indirectly affect your ability to meet product requirements.

 

6.2.2 MEET COMPETENCE REQUIREMENTS

 

Identify the competence requirements of personnel within your QMS who perform work that could directly or indirectly affect your organization’s ability to meet product requirements.

 

Provide training, or take other suitable steps, to meet your organization’s QMS competence requirements.

 

Evaluate the effectiveness of your organization’s QMS training and awareness activities.

 

Maintain suitable records which show that personnel within your QMS are competent.

 

 

 

6.3 PROVIDE NECESSARY INFRASTRUCTURE

 

Identify the infrastructure that your organization needs in order to ensure that product requirements are met.

 

Provide the infrastructure that your organization needs in order to ensure that product requirements are met.

 

Maintain the infrastructure that your organization needs in order to ensure that product requirements are met.

 

 

 

6.4 PROVIDE SUITABLE WORK ENVIRONMENT

 

Identify the work environment that your organization needs in order to ensure that product requirements are met.

 

Manage the work environment that your organization needs in order to ensure that product requirements are met.

 

 

7.

REALIZATION

REQUIREMENTS

 

7.1 CONTROL PRODUCT REALIZATION PLANNING

 

Establish a product realization planning process.

 

Use your product realization planning process to plan the realization of your organization’s products.

 

Prepare planning outputs that are suitable and consistent with your organization’s methods.

 

Develop the processes that you will need to use in order to realize products.

 

 

 

7.2 CONTROL CUSTOMER-RELATED PROCESSES

 

7.2.1 IDENTIFY YOUR UNIQUE PRODUCT REQUIREMENTS

 

Identify the unique requirements that your customers want you to comply with.

 

Identify the requirements that are dictated by your product’s intended use or purpose.

 

Identify the requirements that are imposed on your products by external agencies.

 

Identify any additional requirements that are important to your organization and must be met.

 

7.2.2 REVIEW CUSTOMERS’ PRODUCT REQUIREMENTS

 

Review your customers’ product requirements.

 

Maintain a record of your product requirement reviews.

 

Control changes in customers’ product requirements.

 

7.2.3 COMMUNICATE WITH YOUR CUSTOMERS

 

Establish customer communication arrangements.

 

Implement customer communication arrangements.

 

 

 

7.3 CONTROL PRODUCT DESIGN AND DEVELOPMENT

 

7.3.1 PLAN PRODUCT DESIGN AND DEVELOPMENT

 

Plan the design and development of your products.

 

Control the design and development of your products.

 

Update your planning outputs whenever product design and development progress makes this necessary.

 

7.3.2 IDENTIFY DESIGN AND DEVELOPMENT INPUTS

 

Define product design and development inputs.

 

Maintain a record of design and development inputs.

 

Review your product design and development inputs.

 

7.3.3 GENERATE DESIGN AND DEVELOPMENT OUTPUTS

 

Produce product design and development outputs.

 

Approve product design and development outputs before they are formally released.

 

Verify that product design and development outputs meet design and development input requirements.

 

7.3.4 CARRY OUT DESIGN AND DEVELOPMENT REVIEWS

 

Perform systematic design and development reviews throughout the design and development process.

 

Maintain a record of design and development reviews.

 

7.3.5 PERFORM DESIGN AND DEVELOPMENT VERIFICATIONS

 

Carry out design and development verifications.

 

Maintain a record of design and development verifications.

 

7.3.6 CONDUCT DESIGN AND DEVELOPMENT VALIDATIONS

 

Perform design and development validations.

 

Maintain a record of design and development validations.

 

7.3.7 MANAGE DESIGN AND DEVELOPMENT CHANGES

 

Identify changes in design and development.

 

Record changes in design and development.

 

Review changes in design and development.

 

Verify changes in design and development.

 

Validate changes in design and development.

 

Approve changes in design and development before you implement these changes.

 

 

 

7.4 CONTROL PURCHASING AND PURCHASED PRODUCTS

 

7.4.1 ESTABLISH CONTROL OF YOUR PURCHASING PROCESS

 

Establish criteria that you can use to control suppliers.

 

Evaluate your suppliers’ ability to supply products that meet your organization’s requirements.

 

Select suppliers that are capable of supplying products that meet your organization’s specified requirements.

 

Make sure that purchased products meet specified purchase requirements.

 

7.4.2 SPECIFY YOUR PURCHASING REQUIREMENTS

 

Describe your purchasing requirements.

 

Ensure that purchasing requirements are adequately specified before you discuss them with suppliers.

 

7.4.3 VERIFY YOUR PURCHASED PRODUCTS

 

Establish product verification or inspection methods in order to ensure that purchased products meet purchase requirements.

 

Implement product verification or inspection methods in order to ensure that purchased products meet purchase requirements.

 

 

 

7.5 CONTROL PRODUCTION AND SERVICE PROVISION

 

7.5.1 ESTABLISH CONTROL OF PRODUCTION AND SERVICE

 

Carry out production under controlled conditions.

 

Carry out service provision under controlled conditions.

 

7.5.2 VALIDATE PRODUCTION AND SERVICE PROVISION

 

Validate production and service provision processes whenever process outputs cannot be measured, monitored, or verified until after the product is in use or the service has been delivered (such a process is often referred to as a special process).

 

Establish arrangements to control special processes.

 

7.5.3 IDENTIFY AND TRACK YOUR PRODUCTS

 

Establish the unique identity of your products.

 

Identify the monitoring and measurement status of your organization’s products.

 

7.5.4 PROTECT PROPERTY SUPPLIED BY CUSTOMERS

 

Identify property supplied to you by customers.

 

Verify property supplied to you by customers.

 

Protect property supplied to you by customers.

 

Safeguard property supplied to you by customers.

 

7.5.5 PRESERVE YOUR PRODUCTS AND COMPONENTS

 

Make sure that your products and components continue to conform to requirements while they are being processed internally.

 

Make sure that your products and components continue to conform to requirements while they are being delivered to the intended destination.

 

 

 

7.6 CONTROL MONITORING AND MEASURING EQUIPMENT

 

Identify your organization’s monitoring and measuring needs and requirements.

 

Select equipment that can meet your organization’s monitoring and measuring needs and requirements.

 

Establish monitoring and measuring processes.

 

Calibrate your monitoring and measuring equipment whenever necessary to ensure that results are valid.

 

Protect your monitoring and measuring equipment.

 

Confirm that monitoring and measuring software is capable of doing the job you want it to do.

 

Evaluate the validity of previous measurements whenever you discover that your measuring or monitoring equipment is out-of-calibration.

 

 

8.

REMEDIAL

REQUIREMENTS

 

8.1 ESTABLISH MONITORING AND MEASUREMENT PROCESSES

 

Identify the monitoring, measurement, and analytical processes that you need to have in order to be able to demonstrate conformity and make improvements.

 

Plan how monitoring, measurement, and analytical processes will be used to demonstrate conformity and make improvements.

 

Implement your organization’s monitoring, measurement, and analytical processes.

 

 

 

8.2 CARRY OUT MONITORING AND MEASUREMENT ACTIVITIES

 

8.2.1 MONITOR AND MEASURE CUSTOMER SATISFACTION

 

Establish methods that you can use to monitor and measure customer satisfaction (perceptions).

 

Monitor and measure customer satisfaction.

 

8.2.2 PLAN AND PERFORM REGULAR INTERNAL AUDITS

 

Establish an internal audit procedure.

 

Carry out internal audits of your QMS.

 

Take action to address audit results.

 

8.2.3 MONITOR AND MEASURE YOUR QMS PROCESSES

 

Select suitable methods to monitor and measure the processes that make up your organization’s QMS.

 

Monitor and measure your QMS processes.

 

Take appropriate action whenever your QMS processes fail to achieve planned results.

 

8.2.4 MONITOR AND MEASURE PRODUCT CHARACTERISTICS

 

Monitor your organization’s product characteristics.

 

Measure your organization’s product characteristics.

 

 

 

8.3 IDENTIFY AND CONTROL NONCONFORMING PRODUCTS

 

Establish a nonconforming products procedure.

 

Document your nonconforming products procedure.

 

Implement your nonconforming products procedure.

 

Maintain your nonconforming products procedure.

 

 

 

8.4 COLLECT AND ANALYZE QUALITY MANAGEMENT DATA

 

Figure out what kind of data you need to collect about your organization’s QMS.

 

Collect data about your organization’s QMS.

 

Provide information by analyzing your QMS data.

 

 

 

8.5 MAKE IMPROVEMENTS AND TAKE REMEDIAL ACTIONS

 

8.5.1 IMPROVE THE EFFECTIVENESS OF YOUR QMS

 

Continually improve the effectiveness of your QMS.

 

Use information to improve the effectiveness of your QMS.

 

8.5.2 CORRECT NONCONFORMITIES TO PREVENT RECURRENCE

 

Establish a corrective action procedure.

 

Document your corrective action procedure.

 

Implement your corrective action procedure.

 

Maintain your corrective action procedure.

 

8.5.3 PREVENT THE OCCURRENCE OF NONCONFORMITIES

 

Establish a preventive action procedure.

 

Document your preventive action procedure.

 

Implement your preventive action procedure.

 

Maintain your preventive action procedure.

 

MIE

 

 

 

 

 

 

 

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

Disposal

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

 References

ISO

 

By MIE