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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

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.


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 for our Quality System Internal Audit checklist to make sure you are covered for the quality management processes implied by these 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 Control of Nonconformity, Quality Policy, Quality Assurance Procedure and Quality System Internal Audit Checklist.

Posted by & filed under AS9100.

Customer requirements: even under normal circumstances, reaching agreement could deplete the energy of Hercules. Suppliers might breathe a sigh of relief and feel a tickbox mode coming on when they see that the requirements include mandated use of parts or suppliers.

But what if customer requirements include mandated inferior parts or services that are in conflict with your Approved Suppliers List, currently-approved certification status or immaculate quality system practices?  This tension must be  resolved, preferably before it leaks into the production process or (much worse) into the delivered product, not to mention the vexatious issue of counterfeit parts.

Careful validation and verification by the customer and supplier at the RFQ stage can help management to identify the risk assessment and management within “special requirements” and reduce the need for

  •  tedious Relentless Root Cause Analyses of nonconformances
  • the resulting need for containment
  • a plan for corrective action, re-inspection and final disposition, with due dates for completion and acceptance by the customer
  • disturbance of the production process
  •  product recall

With sufficient care and analysis at the RFQ stage suppliers can identify critical design features, tests, inspection points where customer requirements and current supplier practice are in conflict, and implement procedures to minimize the probability of product escape. Designers and design approval representatives can include this valuable information in design history records and save time and embarrassment if these issues come up in future contracts.

QUALIDOC Quality System Internal Audit Checklist (Customer Requirements) includes all the basic questions needed to cover this vexatious issue.



2Are discrepancies in contracts and agreements clarified, resolved and documented by responsible authorities and are these authorities named in the documents; i.e., Statement of Work?
3Do contract reviews include an assessment of IMH capability to meet customer requirements, including the use of non-standard parts and other special requirements?


5Are contract review activities confirmed with the customer, including the use of customer-mandated items and services which might not meet IMH quality system requirements?


This section is available separately on the Qualidoc website for only £150.







Excerpt from an article by Jean White first published in ASQ Six Sigma Forum magazine: “Your Opinion”, August, 2014.

”Training is
everything. The
peach was once a
bitter almond; the cauliflower nothing
but cabbage with a college education.”
–Mark Twain in Pudd’nhead Wilson’s
Calendar, 1894
Organizations entering the quality system arena through standards such as ISO 9000 and AS9100 might find that, although training is not everything, they will need to increase their training resources. While senior executives acknowledge the need for training, they might not regard it in the same critical light as business processes such as marketing or production.
Inadequate or neglected training, however, can have a serious effect on the certification status of the organization. Standards
boards such as the American National Accreditation Board
and the Standards Council of Canada have warned that
“incomplete reports will no longer be tolerated”—“incomplete” meaning, among other things, nonconformance reports closed out without sufficient root cause analyses. The Boards suggest that unsatisfactory training could be a root cause along with ambiguous procedures and working instructions. They are adamant that they will not accept root causes based
on “employee error, human error, operator error or anyone else who
made an error.” Given these constraints, it can be difficult and time consuming to decide what sort of training is required. Above all, a quality system should be a healthy discipline, not a straitjacket.


Some training needs might be obvious, such as recognizing counterfeit or suspect parts, different reporting requirements, new documentation or processes, or the difference between containment, and corrective and preventive action. Others are more subtle, such as introducing unfamiliar concepts and obligations to employees who often believe the quality system is management’s business.
Employees must be confident about their responsibility and authority, and be committed to the success of the quality system. Clearly, the certification bodies and standards boards expect the certification audits to reflect this commitment. Employees at all levels should be able to answer qualified questions about their work, especially if they are questioned in unfamiliar circumstances such as the assessment for certification. Consider an example from the draft ISO 9001:2015 (ISO underlined words for emphasis):
Clause 5.1—Leadership and commitment:
involving, directing and
supporting persons to contribute
to the effectiveness of the quality
management system.”
Lack of training can show up during the audit when the assessor might ask anyone questions such as: “Can you show me your working instructions?” A relaxed, well-trained employee will refer the assessor to the master document list (also known as the quality
system document index) and the relevant documents without floundering.





Posted by & filed under AS9100.



A new Aerospace Series standard was issued in October 2014:

AS9116 Notice of Change (NOC) Requirements.

It can be used alone or in addition to AS9100C, AS9110 (Aviation Maintenance) or AS9120 (Distributors).


To complicate matters further, AS9116 is for use with AS9100C which is also going to change in 2016. The AS9100 (2016) revision will be based on the new ISO9001:2015 with additions for aerospace requirements.

AS9116 Terms and Definitions require that baseline configurations for the physical product and its performance requirements must be established and verified with the customer.

“Product” as defined in the standard “may include software that embedded is or field loadable in the item”. These configurations form the basis for Design Control. (I can see heads nodding and yes, yes, yes) but be wary; Section 4 Configuration Change Definitions contains among others items such as “Changes that require customer acceptance prior to implementation” and “Changes implemented concurrent with notification for customer acceptance.” (Yes, I know, it took me a moment or two to figure that one out…)


So where should design approval representatives concentrate verification resources? The way I see it, start with the RFQ and its relation to the design history of current contracts. If a new contract emerges:


  • identify at which level in the design NOCs are (or might be) required (including Preliminary Design Review stages)
  •  by whose authority and responsibility they will be issued.
  • resources involved (supply chain)
  • current status of Master Document List (revision status of design documents)
  • identify, establish and verify baseline configurations with the customer together with design change authorisation levels; i.e.,

Customer requirements

Design history from current or past contracts

AS9116 requirements

AS9102 Revision B (R) Aerospace First Article Inspection Requirement issued in October 2014. Also used in conjunction with                         AS9100. AS9102 refers specifically to “…design characteristics of the product…”

AS9103 Validation Management of Key Characteristics


AS9116 is much more prescriptive than usual, but I am happy to say that the QUALIDOC Design Development and Control procedure covers just about everything you need to meet this standard, with help from the invaluable and very popular QUALIDOC Quality System Internal Audit Checklist covering the whole quality system, including Design Control and Development.

Comments on this blog are more than welcome.














Posted by & filed under QUALITY SYSTEM DEVELOPMENT.


The later versions of the ISO standard purport to make it easier for service industries to become certified, but service industries often have a  tough time apply­ing the ISO standard to their activities, especially where nonconforming product control is concerned. I have been successful in these applications by simply converting the product emphasis of the standard to the processes of the service company. For example, I have worked with half a dozen or more marine companies where paper is moved around offices to move ships around the world; moved pulp and paper from railcars through warehouses on to ships; repaired ship components on board and on shore; and sup­plied ships with chandlery (all the odds and ends required by a ship at sea).

For the marine freight forwarding company wanting to be registered to 1SO9001 I looked at the docu­mentation as the product: it began with a Freight Engage­ment (the Contract) and ended with a Bill of Lading (permission for delivery). In be­tween was a mountain of documents including Stowage Plans (how does the cargo fit into the ship), Mates Receipts (the final document of release signed by the Chief Officer on the ship) and various other instructions critical for the smooth handling and transmission of the cargo and ship from port to port.

Much of my work as the consultant was to identify and refine all the docu­ments and make sure the process worked smoothly and communication was watertight between all parties. I treated the nonconforming product re­quirement of ISO as nonconforming conditions, applying the nonconforming product/corrective action section of the stand­ard to the errors in the documentation itself and the processes for which it was used. All my work had to be done in the hectic atmosphere of ships arriving and de­parting. Believe me; you have not lived until you have seen longshoremen drive cars from huge ships on to the dock, having been paid for eight hours if they complete the job in four! Even so, each car was neatly stowed side by side, and very little damage occurred.

My customers were not responsible directly for the care of the cargo. The cargo was under the responsibility of the ste­vedores and terminal operators (who were subcontractors to my customer) during its short stay on the terminal, and eventually under the care of the Chief Officer on board ship, who received it from my customer’s representative (Port Cap­tain). I had to be sure that the Port Captain was not doing any inspections which could ultimately mean recording of Inspection and Tests and Nonconformances, but my custom­er’s relationship with the Terminal Operators removed this responsibility. I just had to make sure that the document used for accepting the cargo met the requirements for authorization.

As part of quality system development for one company I had to visit three Operating Superintendents. They were nearing retirement and two of them had just come off a night call. The Operating Superintendents had a very large degree of personal autonomy. They were on call 24 hours a day and often worked under the most appall­ing conditions. As I walked in the air was blue with tobacco smoke. Coffee was there in gal­lons with large boxes of doughnuts.

After I had my share of the coffee and doughnuts I explained that we were putting together procedures for trainees, and how important it was to get it right. I presented them with the draft of the Final Inspection procedure I had written. We needed to have a formal record of their inspections of cargo under the hook, as it went on board ship. The Chief Officer on board would then sign a Mate’s Receipt if he/she were satisfied that the cargo was in good condition. I invited them to review the procedure step by step, sentence by sentence, and tell me if any changes were needed. Within an hour they had forgotten their resistance and were suggesting changes. We even discovered that we had two versions of a Mate’s Receipt, so we were even able to get rid of a form. I don’t know if they were fully converted, but when the QAM went to check on their use of the procedure at a later date it seemed to be working satisfactorily.

Employees such as operating superintendents are extremely powerful in their environments and this, with their experience, has to be considered when you want to make changes. Too often people sim­ply will not follow procedures if they are not expressed in terms to attract their attention espe­cially when they are in a hurry or working under extremely difficult circumstances. Indeed, getting them to follow proce­dures at any time is a major diplomatic exercise until procedures become a habit. Anyone preparing identification or instruction must take account of the reader’s likely comprehension, location, pressure and any other condition, to prevent an instruction being overlooked or simply ignored.