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.

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.

 

Examples:

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.

 

www.qualidoc.co.uk

 

 

 

 

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

 

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.

www.qualidoc.co.uk

 

 

 

 

 

 

 

 

 

 

 

 

 

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.

 

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

An important part of my job as a quality management consultant is to report to senior management on the status of the quality system as it develops.  I arrange a quality system status meeting once a month. This is not a board or other executive meeting, or a technical meeting. It is a way of ensuring that the quality system development stays on track. It also helps with the training in understanding the requirements.

The report below (QSTAT No 5 ) shows a typical development. Items shown in red have been outstanding for three meetings at which point I give them urgent status unless there is a good reason, such as a ship still being at sea.The items might also appear as nonconformances on the Quality System Internal Audit checklist. The QAM will report on the quality system status as part of the agenda for Management Review of the quality system.

The QUALIDOC Quality System Internal Audit checklist is introduced at the beginning of the contract, with the Quality Policy and Quality Assurance Procedures.

—————————————————————————————————

FROM: JEAN WHITE, QUALIDOC

TO: I. M. HAPPY COMPANY LTD.

ATTENTION: QUALITY MANAGEMENT REPRESENTATIVE

CC: QUALITY ASSURANCE MANAGER

CC: MANAGING DIRECTOR

CC: SALES DIRECTOR

CC: I.T. MANAGER

JANUARY 30, 2015

QUALITY SYSTEM STATUS REPORT (QSTAT) NO. 5

1        Document and Data Control (Master Document List)

Work outstanding:

  • Draft MDL (listing, accessibility and revision status of documents)
  • External documents numbered (e.g, D.O.T Testers’ Manual) and listed on MDL
  • Headings of forms such as Quality System Audit Checklist (Q/C11) edited for consistency
  • Draft forms (e.g., Nonconformance Report, QASFOR 06, and Job Card) verified against current IMH processes, authorities and responsibilities
  • All obsolete documents destroyed or archived.
  • Method of disposal to be verified; e.g., archived via computer system or stored in filing cabinets identified as follows:

“OBSOLETE: RETAINED FOR LEGAL, INFORMATION OR CUSTOMER REQUIREMENTS”

  • “Major” and “Minor” documentation categories to be identified as:
  • MAJOR: any change affecting the quality system and its application (e.g., Nonconformance Reports, Quality Assurance Procedures)
  • MINOR: cosmetic only (e.g., paragraph numbers, formatting).  QUALITY ASSURANCE TEAM (QAT) to decide which category applies, since all document changes are approved by the QAM and QAT.
  • First draft of revised forms (e.g., Works Office Job Card) to be available March 30,2015.  JW to review drafts.

Status: in progress

Responsibility: QAM with (QAT), IT Manager and JW

Due Date: First draft MDL, March 30, 2015

 

2       Inspection, Measuring and Test Equipment

Work outstanding
Up-to-date list required, including current calibration certificates. Old certificates to be removed as for 1 above, unless storage is required for legal or other purposes.

Status: under development

Due Date: first draft MARCH 30, 2015

Responsibility: Work Shop Manager

 

3       Maintenance Equipment

Work outstanding

Same as 2 above, with relevant current certification.

Status: as for 2 above

Due date: as for 2 above

Responsibility: Work Shop Manager

 

4       Management Responsibility and Authority

 Work outstanding

  • Quality Policy Manual: verification by senior management.
  • ISO9001:2008 requires that the Quality Management Representative has management status.  Bureau Veritas (the assessors) will accept that the Financial Director will assume this authority and responsibility, while delegating day-to-day quality system development to the Quality Assurance Manager.
  • The Corporate Organisation Chart and references in the Quality System Manuals must show the QAM reporting directly to the Quality Management Representative.
  • Quality Policy Manual and Quality Assurance Procedures Manual will be amended to show the above.
  • Status: awaiting final draft from JW

Due date: March 30, 2015.

Responsibility: JW, CEO, QMR, SALES DIRECTOR, QAM

 

5                   Approved Suppliers List


Work outstanding

Current list to be edited and redundancies removed.

Purchase Order preparation to be verified as meeting ISO requirement INCLUDING PROVISION FOR PREVENTION OF COUNTERFEIT PARTS PURCHASE..

Status: pending review by QAM with Senior Partsman.

Due Date: first draft by March 30, 2015

Responsibility: QAM, SP and JW

 

6                   Nonconforming Product Control and Corrective/Preventive Action


Work outstanding

  • Introduction of relevant Quality Assurance Procedure into the quality system.
  • Issue of Nonconformance Reports (QASFOR06) for internal audits.
  • Training of staff in the procedure.
  • Introduction of procedure to QAT, who will report potential nonconformance issues at their weekly meetings.
  • QAM  to have sole responsibility (under authority of Quality Management Representative) for issuing NCRs.
  • Documents used in the workshop to report nonconformances and implement corrective action to be reviewed by QAM for inclusion in the relevant quality assurance procedures.

Status: in progress
Due Date: MARCH 30, 2015

Responsibility: QMR, QAM, JW

 

7   Training

Work outstanding

Training Plans and Training Schedules for Quality Assurance Procedures and ISO9001:2008 concepts to be developed.

Training to include verification of Quality Assurance Procedures by all interested parties; e.g., Work Shop.

Status: URGENT
Due Date: first plans, March 25, 2015 (next visit by JW).
Responsibility: JW, QAM, QMR.

 

8       Audit Plan

A draft Audit Plan has been prepared to cover all elements of the quality system (ISO standard components) for one year, to be reviewed following accreditation.

Status: on hold, pending verification of heavy vs. light audit components; e.g., time required to audit each component.

Due Date: March 30th, 2015

Responsibility: QAM and JW

 

9   Measurement and Analysis

Senior management to consider means of measurement and analysis for customer satisfaction and continuous improvement.

Status: first draft to be available March 31, 2015

Due date: March 31, 2015
Responsibility: Sales Director, with CEO, QMR and QAM

 

10 Customer Complaints

 

Establish a procedure for dealing with customer complaints.

Status: pending review of current procedure.

Due date: March 30, 2015
Responsibility: Sales Director with QMR and QAM

 

11      Stores

  • A segregated area to be established for nonconforming items received from suppliers. 
  • A “HOLD” area to be established for items waiting for receiving inspection.
  • Redundant items to be removed.

Status: under development

Due date: March 31, 215

Responsibility: Works Manager and QAM

 

END

Posted by & filed under QUALITY SYSTEM DEVELOPMENT.

We are pleased to announce that our updated quality system development is ready for download. We have put a huge amount of work into this to make sure all our users’ quality systems can be covered within an inch of their lives. The new package places a heavy emphasis on aerospace, defence and space requirements, but will be suitable for any heavy industry such as shipbuilding, ship repair. We are pleased that five major aerospace companies are already registered for the free samples. The Audit Checklists have been used in conjunction AS9101 Revision E auditing requirements to give a more thorough audit and root cause analysis.

For SMEs: this package might seem intimidating, but if you study it carefully it can still save you a lot of time and freedom from development ambiguities. The Quality System Audit Checklist alone is well worth your investment.

See below an extract of industry and other groups using our documentation.

QUALIDOC WEBSITE: 290 USER REGISTRATIONS FROM 31 COUNTRIES AS OF JANUARY 10TH, 2015

INDUSTRY GROUP USER REGISTRATIONS FOR SAMPLE INTERNAL AUDIT CHECKLIST, QUALITY POLICY and PROCEDURES: DOTCOM COMPANIES

INDUSTRY

• SMELTING, METAL, MINING
• ELECTRICAL POWER SUPPLY
• PLASTIC PROJECTION MOULDING
• ENGINEERING PROJECT MANAGEMENT
• HYDRAULIC LIFT SYSTEMS
• AUTOMOTIVE and INDUSTRIAL ENGINE SYSTEMS
• MICROWAVE AMPLIFIERS
• POWER DEVICES, TRANSISTORS
• PLASTICS MANUFACTURING
• WHEELS AND TYRES
• BEARINGS
• BONDED STRUCTURES, TRADING OF MANUFACTURED PARTS, ACCESSORIES MANUFACTURING
• COMPRESSION, TENSION, TRACTION EQUIPMENT
• AUDIO VISUAL PRODUCTS (BANG-OLUFSEN DENMARK)
• SECURITY (NORTHRUP GRUMMAN, USA)
• HERSHEYS CHOCOLATE PRODUCTS
• CABLES, OPTICAL, TOOLS
• INDUSTRIAL HEATING
• TURNKEY/ENGINEERING, PROCUREMENT, CONSTRUCTION
• MECHANICAL SERVICES, OIL AND GAS
• PACKAGING MATERIALS
• SATELLITE GROUND SYTEMS
• MOULDED PLASTICS
• STEEL PRODUCTION AND MINING
• CNC MACHINING, AEROSPACE
• SEWING MACHINES
• RAIL, TRANSIT, INDUSTRY (WESTINGHOUSE)
• AVIATION SPARES AND TECHNOLOGY
• MECHANICAL INSTRUMENTATION (AEROSPACE)
• AIRCRAFT ENGINEERING
• AIRCRAFT PRODUCTION (AERO.BOMBARDIER)
• AIRCRAFT PRODUCTION (SIKORSKY HELICOPTERS, DCMA REPRESENTATIVE)
• AIRCRAFT PARTS FAA APPROVED (ACS-PARTS)
• AIRCRAFT PRODUCTION (ZODIAC AEROSPACE, FRANCE)
• AIRCRAFT MANUFACTURERS (UK)
• LNG NOZZLES
• MARINE COMPOSITES
• PAINT AND WATERPROOFING PRODUCTS AND SERVICES
• CUSTOM THERMOFORMING
• LABEL PRINTERS (PHARMACEUTICAL)
• ELECTRICITY DISTRIBUTION and ENERGY MANAGEMENT
• HIGH PRESSURE PLUNGER PUMPS
• KITCHEN, BATHROOM FIXTURES (KOHLER)
• TELEVISION, WIRELESS, INET (ROGERS)
• CUSTOM-DESIGNED MACHINERY
• MOLECULAR DIAGNOSIS
• WIRE, CABLE MANAGEMENT and DISTRIBUTION
• BIOPHARMACEUTICALS
• LITHIUM ION BATTERIES (QUALLION)
• TURBINE SERVICES
• ENERGY MANAGEMENT
• DIES, JIGS, MOULDS
• CONSULTING ENGINEERS (SYNERGY)
• CALIBRATION AGENCY
• INDUSTRIAL MANUFACTURING AND POWER
• ELECTRONIC SUPPLY CHAIN
• COMPUTER SECURITY
• INDUSTRIAL COMMUNICATIONS
• INTERNATIONAL METALS
• SEALS and PLASTICS

MISCELLANEOUS

• PUBLIC RELATIONS, MARKETING
• TOOTH WHITENING PRODUCTS
• MAIZE STARCH GLUCOSE PRODUCTS
• ECZEMA TREATMENT PRODUCTS
• CERTIFICATION BODY, INTERNATIONAL STANDARDS
• MAGAZINE FOR PARENTS
• APPLE ICLOUD
• EMAIL SERVICES
• INET BROWSER
• DENTAL SERVICES
• QA MANAGEMENT CONSULTANTS
• MARKET RESEARCH and PUBLIC RELATIONS
• COMPUTING SERVICES
• CATALOGUES
• TRADING COMPANY
• GLOBAL HEALTH CARE and RESEARCH
• GOVERNMENT (WESTERN CAPE)
• DOCUMENT MANAGEMENT
• GENERATOR SPECIALISTS
• TOBACCO

MAKE HASTE AND JOIN THE QUALIDOC HAPPY USERS GROUP!

Posted by & filed under Uncategorized.

With insufficient root cause analysis causing so many headaches to standards boards, certification bodies and certification applicants alike, it pays to spend some time evaluating the nonconformances that could lead to insufficient root cause analysis.

At the assessment level major and minor nonconformances have been identified as follows:

MAJOR

The nonconformance has reduced the capacity of the Quality Management System (QMS) to control processes or compliant products or services
Example: nonconformances perpetuated throughout the process, production halted, late delivery
The nonconformances are detrimental to the integrity of the product or service
Example: Discovery of counterfeit or suspect parts too late for recovery
Nonconforming goods have been shipped
Example: revised designs or processes fail to reach production in time to make the necessary changes
The nonconformance has resulted in failure or reduced use of the product or service for its intended purpose
Example: Contract changes reaching design and production too late to implement production changes

MINOR
No failure of QMS or control of processes
Single system failure or lapse (depending on criticality)

These examples are just the tip of the iceberg. Fortunately, the Qualidoc Internal Audit Checklist will help to reduce the risk of insufficient root cause analysis. It is available on the Qualidoc website.