Posted by & filed under AS9100.

The following certification issues are being considered for clarification by AS Senior Document Representatives, following recent discussions by SDRs, CBs and representatives from industry:

 

  • What is considered a single site? (e.g.; a company with three buildings located on three different streets). What is the definition of location?
  • What is considered a ‘lost’ certification? Is it when suspended and/or withdrawn?
  • What kind of an audit is needed for a transfer?
  • Are all sites required to be listed in OASIS and have an administrator for a campus?
  • What is required to be verified in this requirement:
  • “No certificates to AQMS standards or any combination of AQMS standards requiring a certification decision shall be issued, unless all major and minor nonconformities have been contained; satisfactorily corrected with root cause analysis; and the corrective action has been implemented, reviewed, accepted, and verified by the CB.”

Further notes:

“At this time, 80% {of representatives) do not want to separate AS9100 from the base of ISO9001 as has been rumored. There will also be more of a focus on servicing and not just production. They are planning for a 2016 release of AS9100.”

I will update as new information comes in.

Posted by & filed under ISO9001:2008.

One part of quality system costs can be monitored by introducing a tick box on the Purchase Order to track all items and services purchased for the quality system. Quality system purchases can be separated from stationery. toilet paper and pencils.

This information will be useful for the Man­agement Review of the quality system, which has to take place at least once a year. ‘Cost of the quality system’ is always on the agenda. It will also be useful for Measurement and Analysis.

Posted by & filed under ISO9001:2008.

User publications are sometimes given short shrift in design development plans and processes.

Consider the following carefully:

  • how well does the author need to know the product?
  • at which stage should the author(s) be brought into the design process?
  • what does the reader (user) really need to know, as opposed to what the author thinks is a good idea?

Bring the author in at the earliest possible stage –  the earlier the better: in fact, as soon as the design process is under way, at preliminary design stage.

 

 

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

 

AMERICAN SOCIETY FOR QUALITY GROUP (LINKEDIN)

 

RECENT DISCUSSION: You are a Q.M taking on a new position. What are the first things that you would do in your new position?

 

Jean’s comment

“If you start with an internal audit you should discover how the quality system has been managed, and from that an idea of the attitudes, experience, knowledge of the processes and commitment of signing authorities and responsibilities. After this you will have a better chance of conducting useful conversations with senior management and other interested parties and see if your KPIs are worthwhile and if others are needed “

 

Comment in response

 

“ Unfortunately, anecdotal information is not respected by Management, generally; it would be a personal risk acting on only this {introductory discussions with management} information.

For this reason, Jean White’s recommendation is spot on. Once a report is compiled from the formal internal audit and published to Management, and a level of professional trust is established, one can then make plans for drilling down to the causes of problems existing in the system. Ultimately, root cause analysis (done right!) will unearth the systemic causes of problems. Another important reason for using the internal audit approach is that we have to use verifiable evidence/data in our profession.”

 

HAVE YOU REGISTERED YET FOR THE FREE INTERNAL AUDIT CHECKLIST?

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

I.M. HAPPY COMPANY

TRAINING RECORD

 

Employee name:

 

Stage 1: observation of technique  Stage 2: carry out procedure under supervision
Stage 3: carry out procedure unsupervised  Stage 4: qualified to train others

 

 

Training unit & stage

Date completed

Trainee

Trainer (supervisor)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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?