Posted by & filed under ISO9001:2008.

Before the task of maintaining document security becomes too

overwhelming or shamefully neglected, it is prudent

— and will save time and later frustration — to look

at the number and nature of records involved. For

ISO9001:2008 AND AS9100 quality system development,

all documents included in the processes listed below are
“quality records”.

 

Contract, statutory, regulatory, jurisdictional,

Purchasing (approved supplier records),

Receiving and shipping,

Inspection and testing (on and off site)

Design and development (including design reviews),

Production and

Administration (where applicable, e.g., marine freight forwarding)

 

The documents affecting the needs of other interested parties

(particularly customers) should also be considered.

 

Any document that affects the outcome to the customer, or is included in any process affecting certification must be considered a quality record.

 

 

Posted by & filed under MANAGEMENT RESPONSIBILITY AND AUTHORITY: QUALITY MANAGEMENT STANDARDS.

If you think an apostrophe was one of the 12 disciples of Jesus, you will never work for me. If you think a semicolon is a regular colon with an identity crisis, I will not hire you.” Kyle Wiens, in Harvard Business Review. 

Are you:

  • worried about writing the reports and correspondence required for your job?
  • a parent with a teenager who is not making progress with writing?
  • keen to improve your basic writing skills?
  • want to make a good case for yourself in business and personal correspondence?

Writers’ Guide is the essential book for you, to help you create a good impression.  You might even be hired by Kyle Wiens!

 

AVAILABLE FROM AMAZON KINDLE VIA THE QUALIDOC WEB SITE!!

 

 

Posted by & filed under ISO9001:2015.

 

The days are gone when expectations between customer and supplier could include a degree of ambiguity.   The global, and yet most immediate, business environment is unforgiving of error which there is often insufficient time to correct before disaster strikes. Casual arrangements such as those expressed by Leonardo da Vinci trying to get work from the Duke, Lodovico Sforza should definitely go in the bin:

“I can construct bridges very light and strong, and capable of easy transportation, and with them pursue or on occasion flee the enemy, and still others capable of resisting fire and attack, and easy and convenient to place and remove;  and I have methods of burning and destroying those of the enemy.”

(Leonardo didn’t get the job).

The supplier who is accepting a contract will need a Customer Requirement Checklist containing at least the following:

Do I have questions for my customer?

Have I considered the implied needs of the customer which have not been expressed in the Request for Proposal or Quotation?

Am I taking on more than I can handle?

Are all interested parties included in contract review,  such as  engineering, purchasing, quality assurance?

Is our approved subcontractor\suppliers list current and status of suppliers verified against our quality system requirements?

Do we have scheduled contract reviews until our responsibility under the contract ceases?

Do we have a risk management plan, especially for contracts  involving sole source and distant suppliers, security arrangements?

Do we hold supplementary contract reviews at suitable intervals?  (capacity, labour, supplies)?

Do we  have experienced and qualified verification personnel to cover this contract?

Do we  have a procedure for handling customer complaints?

 

The responsibility for making sure that contract conditions are right rests as much with the customer as with the supplier.  At this stage it is easy to make the assumption that small errors can be ignored or can be compensated for at a later stage.  Good business sense, let alone the new standard, requires that capturing and recording small essentials at the initial contract stage is just as important, if not more important, than capturing and recording the processes of the product or service you are offering.

You will need to consider your customer’s needs (evident and implied) at all stages of product and service delivery.

 

HAVE YOU SUBSCRIBED FOR THE QUALITY POLICY MANUAL? YOU NEED THIS TO HELP YOU IDENTIFY WHERE YOUR RESPONSIBILITIES LIE WITHIN THE ISO9001:2015 QUALITY SYSTEM.

Posted by & filed under ISO9001:2015.

MANAGEMENT REVIEW AGENDA:

ASSOCIATED  RESPONSIBILITIES

 

REPORTS

QUALITY MANAGEMENT REPRESENTATIVE (QMR)

  • Status of Actions from last Management Review
  • Report on quality system development
  • Work in hand on the quality system (Control of Nonconformity procedure introduction)
  • Risk assessment and risk management for unresolved nonconformities (e.g., supplier, effect on delivery of services to customers)
  • Changes which could affect the quality system

MANAGING DIRECTOR

  • Identify resources needed for quality system tasks
  • Identify position of quality system development in the IMH business development plan
  • Risk assessment and risk management
  • Performance of services, operational processes, associated practices
  • Changes which could affect the quality system

•      Quality planning and objectives (needs and expectations of customers and other interested parties)

•       business decisions to be assessed regularly for

–   their impact on quality system

–   the impact of the quality system on business decisions

 

MANAGEMENT REVIEW AGENDA:

ASSOCIATED  RESPONSIBILITIES

OTHER ATTENDEES

  • Preventive action strategies (risk assessment and risk management)
  • Quality objectives (strategies for continuous improvement)
  • Cost of quality system
  • Benefits of quality system
  • Training
  • Customer satisfaction levels (implied needs, measurement and analysis techniques)
  • Customer complaints
  • Changes which could affect the quality system

Preventive Action strategies

  • identify items and conditions for improvement in IMH processes
  • identify what has been done to date (e.g., improvement in processes,  equipment, staff training)
  • Refer to QMR reports for possible improvements

Quality Objectives

 

Identify all components of IMH services which are affected by quality system development, e.g.;

  • Customer requirements
  • What is happening to our customer (changes that would affect IMH services)
  • Resources required (e.g., equipment, skills, labour, time)
  • Training
  • Processes (administration, production)

 

 

MANAGEMENT REVIEW AGENDA:

ASSOCIATED  RESPONSIBILITIES

 

Page three

 

Cost of quality system

 

  • Cost of quality system; e.g., staff time, consulting fees, equipment, staff training
  • Projected costs for quality system development during, and until,   assessment and certification stage

 

Benefits of quality system

 

Identify benefits to date; e.g., production time saved, processes clearly understood and verified by users, authority and responsibility identified

 

Customer Satisfaction levels and Customer Complaints

 

  • Identify method(s) for measuring customer satisfaction.  What constitutes customer satisfaction for IMH customers?  Where is this not happening?  How can we improve our service to customers? (Not only in response to customer complaints, but anticipating customer needs.  This is done as far as possible at the quotation and contract stages).

 

Measurement and Analysis Techniques

 

Identify trends which can be measured; e.g.,  nonconformity, Key Performance Indicators (KPIs) – measurements must be beneficial to the organisation and improve organisation’s performance

 

 

 

 

 

 

 

 

 

Posted by & filed under AS9100.

AS9101 Rev E PROCESS AUDITING.  See below some questions to help you (SEE ALSO QUALIDOC INTERNAL AUDIT CHECKLIST – REGISTER ON THIS SITE FOR YOUR FREE COPY)

 

EXAMPLES: Heat Treatment and Welding are processes

Contract Review and Inspection and Test are processes

 

  • Is the process identified and defined appropriately?

 

  • Are responsibilities and authorities for process performance recorded and assigned?

 

  • Are the connections identified between stages, authorities and responsibilities (Who needs to know? Which documents are involved? What is their revision status?)

 

  • Are skills and equipment identified?

 

  • Is the process implemented and maintained?

 

  • What is the desired level of performance?

 

  • What is the current level of performance?

 

  • Are the desired results achieved?

 

  • Is the desired level of performance recorded accurately?

 

  • Does the process include customer-specific requirements, i.e., targets, performance?

 

  • Is the process operating, as defined?

 

  • What are the performance measurements (e.g., Key Performance Indicators)?

 

  • Is the process performance regularly reviewed by senior management?

 

 

  • Where performance lags, are improvement plans in place?

 

Posted by & filed under ISO9001:2008.

 

Training for ISO9001 – all employees

The ISO9001 quality management standard: what does it mean for our business?  It means our commitment to:

  • Coherent, connected processes
  • Employee involvement
  • Increased awareness of customer’s needs
  • Fewer customer complaints
  • Continuous improvement

How can we meet the above objectives and the requirements of the standard? We can record errors and omissions (nonconformances) that might affect our service to customers, or waste time in our daily work.  This is really important; we can correct errors and omissions AND  recognise the potential for error.

Everyone in the organisation is involved in developing and maintaining a quality system.  Everyone should have an opportunity to suggest changes via the Quality Assurance Team, and be part of the “continuous improvement” required by the standard.

The quality system is not separate from the day-to-day way running of our business;  it IS the way in which we run our business.

 

 

Posted by & filed under AS9100.

Latest from AAQG Registration Management Committee: Workshop Indianapolis, IN

July 18-19, 2013

 

Changes to PEARs

Now structured into (4) Sections

Section 1 – “Process Details” identifies Inputs, Activities, Outputs and Interactions

Section 2 – “Process Results” includes the identification of performance measures and KPIs

Section 3 – “Process Realization” summarizes audit trails and sources of evidence (formerly recorded on the OER)

Section 4 – “Process Effectiveness” includes an evaluation matrix (to be used after a process has been assessed)

 

 

 

 

Posted by & filed under Uncategorized.

Welcome to subscribers in the USA, UK, Canada, France, Belgium, India, China, Switzerland,.  They are in aerospace, pumps, health, plastics and many other interesting industries.

Watch this blog for up-to-date and useful quality management information.

Posted by & filed under ISO9001:2008, Uncategorized.

NEW!! SEE SAMPLE PURCHASING QUALITY POLICY ON THE QUALIDOC WEBSITE.

 

SUBSCRIPTIONS ARE AVAILABLE VIA WWW.QUALIDOC.CO.UK FOR ACCESS TO THE FULL QUALITY POLICY MANUAL.  THIS IS YOUR ORGANISATION’S COMMITMENT TO A FORMAL QUALITY SYSTEM.   QUALITY ASSURANCE PROCEDURES WILL BE AVAILABLE TO VALIDATE AND VERIFY THE POLICIES.

 

LET YOUR CURRENT AND PROSPECTIVE SUPPLIERS KNOW ABOUT YOUR PLANS FOR CERTIFICATION.

 

DRAFT LETTER TO SUPPLIERS RE  ISO9000:2008 PROGRAM

DEAR SIR/MADAM:

As part of continuous improvement at I. M. HAPPY COMPANY we are developing a quality management system which complies with the ISO9000:2008 international quality management standard.   One of the requirements of the standard is that we record the criteria for selection, evaluation and re-evaluation for each supplier. This is commonly done through an Approved Suppliers List.

The criteria for being on the List will be established by (IMH AUTHORITY) and we shall notify you of the acceptance criteria for your company in due course.

We look forward to receiving our ISO9001:2008 certificate, and (within the requirements of the ISO9001 standard) continuing the customer/supplier relationship we have with your company.

 

Yours etc.

 

 

Posted by & filed under Uncategorized.

 

Is our Statement of Work clearly expressed and accurate?

Do we have regular contract reviews until our responsibility under the contract ceases?

Is our approved subcontractor\suppliers list current and status of suppliers confirmed?

Have we allowed for the various levels of approval required for our product or service which could be critical for invoicing and payment; e.g., government and other prime contractors?

Is our subcontractor/supplier in close competition with others in the market which could lead to cutting corners?

Do we need to know if our subcontractor:

  •  Has an approved subcontractors\suppliers list?
  • Has a risk management plan, especially for contracts involving sole source and distant suppliers?
  • Holds supplementary contract reviews at suitable intervals?  (capacity, labour, supplies)?
  • Has experienced and qualified verification personnel?
  • Has a procedure for handling customer complaints?
  • Has a procedure for distributing contract amendments promptly to affected personnel?