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Posted by & filed under Uncategorized.

During one of my contracts in marine freight forwarding I worked with a Maintenance Foreman who was responsible for isolating and identifying nonoperational forklifts used to move cargo. His habit was to remove the forklifts to a corner and attach a small (grubby) tag marked ‘DO NOT USE’ to each one.

Unfortunately, the night shift operators would decide that they needed an extra forklift, or another forklift would go out of action, and they would take one of the deficient forklifts back into operation. Much cursing, wasted time and frustration occurred the next day in tracking the whereabouts of the OOO forklifts. Clearly, the identification was inadequate for the job it was supposed to do.

With the QAM’s involvement, we set up a segregation (quarantine) area marked “NONCONFORMING ITEM: DO NOT REMOVE”. We devised a big tag with a skull and cross bones and the words ‘OUT OF ORDER! DO NOT MOVE!’ As identity for a nonconforming item (a controlled document) the tag carried a serial number, an NCR number from the NCR Log and a brief account of why the machine was out of action (leaking oil, gears seized).

This example shows that often people do not follow procedures and other instructions if they are not expressed in sufficiently dramatic, simple or sizeable terms, especially when they are in a hurry, or working under extremely difficult or hazardous conditions.

The document’s revision status should be current, at point of use and legible to the reader. The reader must always be considered when preparing any document. Quality records should be reviewed periodically with these considerations in mind. Any document on the Master Document List needs this kind of review.

Posted by & filed under Uncategorized.

 

The zeal for “measurement” and “continuous improvement” expressed through numbers has been gaining strength for some years. I have even seen one comment that “nothing in process development was any use unless it was, or could be, measured”.

I maintain that measurements can’t be made, or make any sense at all, unless they derive first from categories which are specific and concise: in other words, vocabulary (categories). For example, in managing risk we have to decide where there is potential for risk: what I call the “point of failure”, essential for relentless root cause analysis.

In identifying potential points of failure we are obliged to look at design, product development, process, documentation, employee calibre, environment, to name a few. The correspondence between description (category) and reality (condition) must be leak-proof, free from ambiguity and cause no delays in judgement.

I can hear the statisticians protesting about the rejection of numbers analysis, but a number does not say what is, except for counting heads and items; it simply indicates a condition which has had to be defined and clarified elsewhere by vocabulary.

The work in defining categories is well worth while if numbers are to provide true value as measurements for quality system assessments and other critical conditions

Posted by & filed under Uncategorized.

FROM: JEAN WHITE, QUALIDOC
WWW.QUAlIDOC.CO.UK

 

Apprentices are not confined to the “shop floor”. In my recent workshop on quality management for apprentices I had eight PhD university student/apprentices. They are working and studying. This is why we should get rid of the belief that students go to university or college and get a degree (with enhanced career potential) and apprentices’ career route is solely via training in a chosen industrial environment,with restrained potential for career growth.

Apprentices should be aware of the management structure; its responsibility and authority levels throughout the entire quality system from customer requirement (contract review) to delivery, where contract responsibility ceases for all interested parties.
Do you have an apprenticeship or other industrial training programme?

Does this include an introduction to quality management systems (QMS), including processes, authority and responsibility, documentation?

Are apprentices instructed in the role of quality management in engineering (e.g., aerospace, construction)?

Are they aware that the authority and responsibility of Quality Engineers can include the requirements of ISO9001:2008 (2015); e.g., formal design reviews, and participation in QMS internal audits?
Who is responsible for training new staff in company processes?

Do induction and other training plans include quality assurance at all stages of employment? For example, QMS involvement in new contracts, revised contracts, revised processes, revised industrial and quality management standards?

Are authorised and responsible personnel in the company (e.g., engineers, drawing office, purchasing) prepared for the sudden advent of formal QMS requirements arising from new contracts and amendments to contracts?Despite

Is the organisation up-to-date with verification of the QMS including
• allowing for ISO9001:2015 and AS9100D
• sufficient root cause analysis for nonconformances
• supply chain verification especially for counterfeit and otherwise suspect parts?

 

 

 

 

Posted by & filed under AS9100, ISO9001:2015.

Early identification of customer- implied special requirements or potentially critical items:

provides design engineering with valuable information which they can use for design implementation and design history.

provides management with acceptance rationale for those requirements or items,

identifies the means by which emerging risks can be controlled and mitigated,

enables critical design features, tests, inspection points to be identified,

flags the need for procedures to be implemented to minimize the probability of product escape where requirements have been met but the product fails at First Article Inspection, so preventing failure of a product, mission or loss of life.

A vigilant review of design history with each new contract can help to avoid or eliminate design and production errors. A scheduled review of current contracts will eliminate the need to recover lost resources where changes have occurred in customer requirements.

 

 

 

 

 

Posted by & filed under CERTIFICATION BODIES.

Certification Bodies (CBs) are currently the focus of dissatisfaction in some LinkedIn groups.Many of the comments express disappointment (to put it mildly) at what they consider is the lack of thorough audits by some assessors.

It’s worth noting that there is a rigorous review of reports submitted by assessors to their CBs and onward to the relevant Standards Board. It is also worth noting that some Standards Boards  are returning reports to CBs as unacceptable where the Boards consider that nonconformances are closed out with insufficient root cause analysis.

I suggest that this threat alone would compel any assessor to govern himself or herself accordingly during assessment and when preparing the recommendation report. Consider the embarrassment of having to go back to the client with a rejected report on these grounds, not to mention the expense incurred from extra time on site and lost time to the client. Imagine the chagrin and disappointment where a client has to submit to more investigation when they have just finished popping the champagne corks.

As a quality management consultant of many years experience I have certainly had my share of what I considered to be unacceptably inattentive certification assessment. I recall one assessor from a well-known prestigious CB who sat in the MDs office for the entire assessment and even issued a favourable report. I complained to the CB through the formal process and was clear where I believed the assessor had failed my client.
I have CBs on file with which I have worked and know they will be rigorous and fair. From three of these, I discuss the terms with my client and we choose one which most closely meets our requirements:such as knowledge of the product or service, fees, preassessment visits, time needed on site.

We naturally expect that all the hard work we have done for months before the assessment will be assessed rigorously.   Beyond a careful choice of CB, however, we have to rely on the integrity of the CB, their certified assessors and the reporting process to the Standards Boards.

 

Posted by & filed under ISO9001: RISK ASSESSMENT AND MANAGEMENT.

 

 

With all the emphasis on measurement in the ISO9001 standard it is sometimes easy to overlook the importance of some day-to-day processes that are just as important but not as glamorous.  For example, what does handling, packaging, shipping, delivery mean in your business? It could mean delivery to a specific site, or conclusion of system installation, or when the prod­uct leaves your warehouse or site, or when a ship arrives to discharge cargo at a port thousands of miles from your site.  It pays to consider carefully where the company’s responsibility ceases. It is too late when the signatures are dry on the contract.

 

Other questions come to mind: which carriers do you use? Are they available at all hours of the day and night, should you need that kind of service? Are they on the Approved Suppliers List? Are you responsible for delivery to a site other than that of your cus­tomer? Who has authority in your company for releasing the product or service to the customer? Which of your custom­ers’ representatives has the authority to accept delivery of a product or service from you?

 

What does “preservation” imply for your business? For international quality standards it means protect­ing items from deterioration; for example, by shrink wrapping, other special packaging, or surface treatments.

 

Is your storage adequate? It’s too late to assess space when new equipment arrives and won’t fit the space you have allocated. Extra storage could be needed such as racks, shelves, cupboards, along with packaging materials for production equipment and tooling. I always include this in contract review and RFQs as it might mean extra costs. Bear in mind standards such AS9116 (Notice of Change) issued last October which requires design changes to be reported to the customer unless otherwise specified in the contract. This might seem a far cry from what happens in the storage area but could affect storage if larger parts are introduced into the production process.

 

Extra storage space might be easy to estimate, but what about other conditions such as temperature and humidity for critical parts, including parts for which the customer might have set the storage and preservation criteria? You might need something as simple as a protective blind to protect items from excessive sun. This problem came up in one of my contracts where fabric was glued and the hot sun through a window altered the consistency of the glue as it was being used. The fabric was to be used as part of a life raft. (Consider the implications of that kind of failure).

 

As far as the quality system is concerned the knee bone is definitely connected to the thigh bone; all elements are connected. When considering risk assessment and management It pays to”lend the eye a terrible aspect” (as Skakespeare said). Be conscientious and give all elements the same level of respect.

Posted by & filed under ISO9001: RISK ASSESSMENT AND MANAGEMENT.

The demand for risk assessment and risk management in the current quality management standards can immobilise the most dedicated executives, not to mention the quality management representatives. Out of pity for their dilemma and misery I offer the following questions, which are extracted from the Qualidoc Quality System Internal Audit Checklist at www.qualidoc.co.uk.

Are the quality system, quality objectives and business objectives reviewed regularly FOR RISK against the following:

  • Development of innovative product or service, including software?
  • New or strategically important customer acquired?
  • Loss of strategically important customer?
  • New techniques developed, including software?
  • Significant changes (planned or not) in the business?
  • Process changes?
  • Transfer of work?
  • Change of supplier where parts become obsolete or otherwise unsatisfactory, especially where counterfeit parts might enter the supply chain?
  • Changes in regulatory, statutory or quality management standards?

These are all questions based on my experience on the shop floor and also verified information received from my valuable contacts in aerospace and other heavy industrial users having to meet stringent quality management requirements.

Posted by & filed under QUALITY SYSTEM DEVELOPMENT.

“I am so clever that sometimes I don’t understand a single word of what I am saying.”

Oscar Wilde, The Happy Prince and Other Stories

I hope I never give that impression with my writing. I sometimes edit my writing to the extent that I come full circle, back to where I started (well, almost).

Unfortunately, in quality system development, Documentation Control still takes far too big a toll on certification assessments and can create chaos if not given sufficient attention. One of my first tasks in any contract is to review the documentation, get rid of anything that is redundant and make sure all the rest is fit for purpose.

It is one thing to identify which documents are needed (and well done if you have managed that) and another to make sure they contain the correct information in terms that are familiar to the reader, and clear if the reader is unfamiliar with the process.

Many years ago I was given a contract by a national railway company to work with retired engineers who were rewriting maintenance procedures for locomotives. Their idea of a pro­cedure was to extract lumps of information from General Motors and other Original Equipment Manufacturers (OEMs) hefty instruction manuals, and plonk them onto sheets of paper ad hoc.

Many painful months later I had managed to persuade them to set out a logical sequence of events with the readers’ needs in mind; e.g., if oil on a hot engine was a safety hazard, then Page 8 was not the place to state it. Warnings, (especially safety) had to be on Page 1, Para 1.

The reader’s needs are paramount. If the reader loses interest or focus you have wasted your time, par­ticularly when you are trying to persuade employees of long experience and standing in the company that changes are needed. You can’t make a big splash when the tide is out. Before distributing the documentation even in the first draft. ask yourself:

  • Is the information in the logical sequence which is most beneficial to the reader who is following the instruction?
  • What is the preceding connection which the reader may need to know so that he or she can pick up the threads?
  • Can the reader discover quickly where he/she is, by page and part?
  • Is high order language used to ensure the appropriate level of formality without slipping into obscurity?

Many people are mad about flow charts and are convinced that they are the answer to all information processing needs. Flow charts are excellent when they portray step by step proc­esses which require no assumptions to be made on the part of the reader. Too often I have found the categories have been named without sufficient accuracy, and so the reader is left floundering and making assumptions, which can be awkward, if not disastrous. Flow chart categories must be specific and connections  must be watertight. They should also show responsible authorities within each step; that is, Operating Superintendent, not John Brown. John Brown’s name will show on the Signatories List which is part of the Master Document List.

More critical questions to be asked before developing documentation are:

Who is the reader?

What does he or she need to know?

When do they need to know?

Who approves the first and subsequent drafts and authorises publication?

Who is in charge of the Master Document List? (Usually the Quality Management Representative or delegated authority, shown on the Corporate Organisation Chart)

Who needs access on a Read Only basis?

Are all interested parties identified who might need copies and are the copies controlled or uncontrolled?

It pays to submerge our egos when undertaking this very important task. We can’t afford to imitate Oscar Wilde; too much is at stake.

THE QUALIDOC QUALITY SYSTEM PACKAGE CONTAINS ALL THE DOCUMENTS NEEDED FOR A COMPREHENSIVE QUALITY SYSTEM. MANY DOCUMENTS ARE PROVIDED WITH LINKS TO THE PROCEDURE. OTHERS ARE INDICATED WITH THEIR PLACE IN THE PROCESS.

Posted by & filed under AS9100.

 

The documentation trail is critical in the prevention and discovery of suspect, fraudulent and counterfeit parts. You can protect the integrity of your quality system and reduce the likelihood of these parts entering your production chain by checking the following documents:

  • Certificates, packing slips tracing the movement of the material back through supply chain to origin
  • Certification that the material has not been salvaged, reclaimed, otherwise used, or previously rejected for any reason
  • Certificates of Conformance or other documentation: their authenticity and applicability to the delivered material, including:
    • Lot and/or date codes on the packaging match the lot and/or date codes on the parts
    • Logos, trademarks and other identifying marks match manufacturers’ marks as applicable
    • Changes to or irregularities in the documentation trail, especially authorised signatories
    • Part number marked on the material matches the part number on the PO and Certificates.
    • Materials are consistent with the description on the supplied documents
    • Serial number discrepancies or duplication of UII (Unique Item Identifier)

Applicable standards

AS6081: Distributors procuring and selling electronic components

This standard is for distributors of electrical, electronic and electromechanical parts that are:

  • purchased and sold from the open market/unauthorized sources, including purchased excess/surplus and purchased returns.

This standard is NOT for:

  • aerospace integrators, OEMs or for Authorized (Franchised) Distributors and Aftermarket Manufacturers when supplying parts obtained directly from the Original Component Manufacturer’s (OCM) or the OCM Authorized (Franchised) Distributor for whom they are authorized.

AS6174: Organisations procuring non-electric parts and assemblies (broker distributor and independent distributors)

AS5553A: Manufacturers procuring and integrating electronic components.

Where does this apply within the organisation? Make a good start with Customer Requirements (Contract Review) which should include a review of customer-mandated parts before these requirements are translated into Design and Development (where applicable) and then Purchasing. A rigorous analysis of these requirements at these levels will be well worth while.

See www.qualidoc.co.uk for our Quality System Internal Audit checklist to make sure you are covered for the quality management processes implied by these standards.

 

 

 

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

I realised a long time ago that trying to assign categories to Customer Complaints was a walk in a thick fog and wasted a lot of time, including my own. Category errors can be a major source of dysfunction in a business, but the pain of trying to fit customer complaints into a category straitjacket can be avoided.

I identify first of all where the complaint occurred, who was involved, then the cause.

Where did the complaint emerge? (the point of use for the product or service).

Who was involved? (including the customer who made the complaint). Consider anyone involved with the application of the quality system (standard); e.g., management responsibility and authority, Document Control (including CM), contract review, ship movement, software development, processes, Procurement (purchasing and suppliers), all of whom are included in the quality system.

What was the cause? This requires Relentless Root Cause Analysis. For example, a review of NCRs (open and closed) could reveal that corrective action was not implemented in sufficient time to prevent the effect on the customer. But remember that an incorrect procedure might not be the only fly in the ointment. Insufficient training could be the culprit.

This approach does not mean introducing new vocabulary into the organisation. The current processes and procedures can be maintained. The resulting information is much more likely to produce satisfactory results for the customer and (more important) prevent the same, or similar complaints occurring again.

It is worth noting that Standards Boards are clamping down on Certification Body reports which contain nonconformances closed out with insufficient root cause analysis. Also the OEMs have been complaining directly to the Standards Boards on this issue.

I am pleased to say that Qualidoc covers the standards comprehensively, but I am always working towards perfection!

See www.qualidoc.co.uk Control of Nonconformity, Quality Policy, Quality Assurance Procedure and Quality System Internal Audit Checklist.