Posted by & filed under CERTIFICATION BODIES.

For some months a discussion has been raging on a LinkedIn group around the possibility of establishing an international data base to which organisations could refer if they wish to confirm the certification status of a company or agency re ISO standards.The data base would be set up using the International Aerospace Quality Group data base, OASIS, as a model.

While this might seem a very attractive proposition, purporting to save time now spent in checking accredited lists in many different countries, I believe there is one major hurdle which its more enthusiastic proponents don’t seem to have considered.

The OASIS database is a product of the International Aerospace Quality Group (IAQG). OASIS houses supplier and audit assessment data for all companies who hold an accredited certification in any of the AQMS series of Standards (i.e. – AS9100, AS9110 and AS9120). The International Aerospace Quality Group (IAQG) has set firm requirements regarding the inclusion of aerospace certified suppliers in the OASIS database. It is not optional – if you hold an accredited certificate to AS9100, AS9110 or AS9120 – you must be entered into the OASIS database. SAE International document AS9104 details the Certification Bodies’ requirements for Aerospace Certification Programs.

If any aerospace certified supplier refuses to be a part of OASIS, or refuses to set up an OASIS administrator, Certification Bodies are required by the IAQG to revoke the certificate of registration.

It is one thing to register all certified organisations on an international database; it is quite another to impose the above restriction.

 

 

 

Posted by & filed under ISO9001:2008.

How do we manage quality system training for employees who are on site for short periods, perhaps only two or three hours or days? For example, many temporary employees are hired by the day from union halls. They will work in many different companies and environments.

I helped to prepare a Pulp Handling Handbook for a marine freight forwarding company, for use in the warehouse by temporary employees. It was very simple with pictures of damaged (nonconforming, unaccept­able) and non-damaged (acceptable) pulp and the applicable forms. Employees who had been on site for only a few hours could recognise a nonconforming situation in a contained environment and inform their immediate supervisors.

These employees often suggested improvements to the quality system based on their experience of conditions and processes along the waterfront. “Best practices” became obvious as more and more employees recognised what was working for them and making the job easier.

No need to discount temporary employees’ contribution to continuous improvement. Best practices discovered during such employees’ brief tenure can translate into improved customer relations and economies of time and labour.

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.