Posted by & filed under Uncategorized.

 
How do we trace a part?

Answer: (EXAMPLES):

  •  Inspection and Test Records
  • Purchasing
  • Tags

Who is the Quality Assurance Manager (QAM)?

Answer:
(INSERT NAME)

What are the QAM’s responsibilities?

Answer:
To monitor and implement the ISO Quality System.

To report to management on the status of the quality system

To convene and chair the QUALITY ASSURANCE TEAM   

What do you know about ISO?

Answer:
ISO IS AN INTERNATIONAL STANDARDS ORGANISATION BASED IN GENEVA SWITZERLAND.
Note: More than 132 countries have an agreement with ISO to register companies to ISO9000 standards

How do you know how to do your job?

Answer:
XXX years of experience….
my certificate in…
my working instructions which are kept in…
and my company training.

How do you recognise a non-conforming part or condition?

Answer:
A part or condition which does not meet CUSTOMER or I.M.HAPPY CO’S quality system requirements (receiving, in-process
and final inspection).

What is the IMH Company Quality Policy and where is it kept?

Answer:
I can refer to the Quality Policy Manual and the Quality Assurance Procedures Manual in the MASTER DOCUMENT LIST, XXX DRIVE.

What does the Quality Policy mean to you and your job?

Answer:
It means complete customer satisfaction, and continuous improvement in my skills

Where in the Quality Assurance Procedures Manual will you find a reference to your job?

Answer: (for example)
WORKS: Process Control, Stores, Inspection and Testing
Receiving: Handling, Storage, Packaging
Preservation and Delivery, Inspection and Testing

Where is the Master Document List?

Answer:
ON THE (INSERT COMPUTER LINK HERE)

Why do you need the Master Document List?

Answer:

To check forms, policies and procedures and other documented information and make sure I am working to the latest revision.

Who is responsible for keeping the Master Document List up to date?

Answer:
The Quality Assurance Manager.

Who is allowed to make changes to the documents we use?

Answer:
ONLY the Quality Assurance Manager with the Quality Assurance Team.

EXCEPTIONS: EXTERNAL DOCUMENTS SUCH AS (INSERT EXAMPLE)

How do you recognise a Non-conforming Part?

Answer:
It is tagged with a ‘Non-conforming Item’ tag (INSERT EXAMPLE)

If I want to suggest a change to a form or procedure, what do I do?

Answer:
GIVE suggested amendment, or draft of new form, to a member of the QUALITY ASSURANCE TEAM, who will pass it to the QAM.


 

Posted by & filed under ISO9001:2008.

What is a Quality Plan?  I am often asked this question – I offer the following:

A quality plan is a document that specifies

  • which procedures and associated resources shall be applied
  • by whom
  • and when

to a specific project, product, process or contract
requirement.

“Procedures” can include quality assurance procedures such as Inspection and Test, Purchasing.

Posted by & filed under Uncategorized.

The proposed additional clauses for ISO9001:2015 are as follows:

 

9. Performance evaluation

  •  Monitoring, measurement, analysis & evaluation
  • Internal audit
  • Management review

10.Improvement

  •   Non conformity and corrective action
  •  Continual Improvement

“Documentation Requirements” has been changed to “Documented Information”.  We will need to think carefully about that one!

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

This Qualidoc agenda has proved its worth for many years quality system management in aerospace, marine freight forwarding, ship repair, IT, among others.

Used with a disciplined set of Minutes it is a reliable tool for monitoring the requirements of the ISO9001:2015 and the revisions to AS9100 that will result from the new ISO standard. It will also prepare for audits against the auditing standard AS9101 Revision E, due out later this year. See my blog AS9100 and Aerospace Manufacturing magazine article, April 2013 issue.

 

Who should attend? CEO and other top management executives.  How often do you need this review? I recommend three to six month intervals while quality system is settling down. Thereafter annual review is sufficient, depending on the nature of your business.  It is IMPORTANT to follow through on the corrective action arising from this review.

A. QMR report – status of quality system:
• results from internal audits
• corrective and preventive action
• regulatory, industrial and international standard compliance
• customer complaints
• quality objectives

B. Risk assessment and management
C. Quality objectives (strategies for continuous improvement)
D. Cost of quality system
E. Benefits of quality system
F. Training
G. Customer satisfaction levels (implied needs)
H. Changes in processes and business strategies that could affect the quality system

QMR is Quality Management Representative, aka Quality Assurance Manager

WATCH FOR THE QUALIDOC QUALITY POLICY MANUAL AVAILABLE SHORTLY FROM THIS WEB SITE WITH SAMPLE MANAGEMENT AUTHORITY AND RESPONSIBILITY FOR A QUALITY MANAGEMENT SYSTEM.

Posted by & filed under Uncategorized.

CONTROL OF QUALITY RECORDS: a major task for quality system development.. Ask the following questions, preferably at contract stage:

 

Which documents are critical for the quality system and must be controlled? (contract to delivery stage)

Who will control the MASTER DOCUMENT LIST (one authorised person)?

How will authorised persons access the List?

Who will have “read only” access?

Who will have authorised access for review, revision? (usually the Quality Management Representative (QMR)

Have the documents been subjected to the severest scrutiny before issue? e.g.,

  • verification of content
  • identity of reader (who needs to know)?
  • logical sequence of processes with the reader in mind (policies, procedures, working instructions, forms)
  • grammar, spelling, vocabulary

Where do the documents begin to appear in the design and production process?

Are user documents included (customer, regulatory bodies, other interested parties)?

What is the distribution? (Please, no uncontrolled copies!)?

What are the intra- and interdepartmental connections for each document, with authority for receipt and distribution?

Are other interested parties involved?

Where will hard copy documents be kept (secure from damage or other deterioration)

Who will be in charge of the documents at point of use?

Has documentation development been included in the quality plan?

See also Documentation Requirements section in the Quality System Internal Audit Checklist available FREE from this web site.

 

 

Posted by & filed under Uncategorized.

Numbers are growing daily – it’s good to see so many brave souls checking their quality systems with the Qualidoc Quality System Internal Audit Checklist!

Watch the website for the issue of the Quality Policy Manual where you can make a good start on your quality system or smarten up the current system. This will be available shortly.

Posted by & filed under THE ISO9001 CHALLENGE, Uncategorized.

 

Not clear how ISO standards would apply to your everyday operations?

Not sure you can commit the required resources and energy?

Fear the perceived bureaucracy and paperwork that could be involved?

BUT you might need an ISO standard for

 

a new contract requirement

entry to a new (to you) or emerging market

more disciplined approach to your business

Check your current status via the QUALIDOC internal audit checklist – a really good place to start.

Available FREE  at www.qualidoc.co.uk

Posted by & filed under Uncategorized.

The ISO quality standards are not techniques which can be learned and dropped if not convenient. They are concepts which must be converted into techniques to reflect the processes of each organisation.

The techniques are company-specific and the consultant’s job (as I see it) is

  • to help the customer de­velop those techniques
  •  to make sure the ISO requirements are met with­out creating a gridlock in the organisation
  •  to discover the unknowns which cannot always be ac­counted for by management strategies

This development can be a huge culture shock. People are not used to describing and recording what they do as a logical sequence of events.This has to happen if you want a quality system that will pass muster with the assessor and benefit the organisation.

To see how your company or organisation is doing, download the FREE INTERNAL AUDIT CHECKLIST from www.qualidoc.co.uk – a really good place to start improving your business.

Posted by & filed under AS9100.

 

A word of caution: make sure your Purchase Orders or Standing Orders contain the complete specifications against which you want the product delivered. If you require Certificates of Com­pliance or Conformity. make sure they accompany the prod­uct when you receive it. When you have placed a Standing Order with a supplier they should submit updated certificates or some other confirmation of compliance each time they make a delivery against that order.

During an ISO9001 assessment at which I was present the audit revealed a certificate that was ten years old, issued for infrequent, long-term delivery of items needed in production. My customer had not asked for certifi­cates of compliance after the first purchase, on the grounds that the supplier was always dependable and the items would be delivered a batch at a time, based on the original Purchase Order. Unfortunately, the assessor did not take this view, and we got a minor non-conformance (the only one, much to my chagrin).