One of my first jobs on a contract is to review documents currently in use which could be included in quality records. A common issue is naming documents with insufficient clarity, aka category errors. On one contract I discovered what was supposed to be a Design Change Notice (DCN): was headed ‘Change Notice’. I knew what an important document this usually is for ensuring that design changes are passed on to the assigned design authority ESPECIALLY WITH THE ADVENT OF AS9116 NOTICE OF CHANGE.
In my experience the assessors regard the following as two non-conformances:
- they perceive that someone is ignoring the quality system (e.g., not everyone is committed to the system and it is not under control)
- uncontrolled documents (no central record, poorly numbered or otherwise identified, poorly located, no check on issue or revision status (Master Document List, Document Index).
The assessors may overlook one or two isolated instances where forms are not signed or procedures are not followed, but if they find more than one or two they might regard this as a trend. Non-conforming trends mean that the assessors will stay on your premises much longer while they dig around for more evidence. If they find trends, then they will issue a major non-conformance which has to be corrected before you can be recommended for certification. Who wants to drag through all that again? Better to get it right the first time.
Working instructions are a critical part of quality records and DOCUMENT CONTROL. They will be examined by the assessor for their availability to the employee at point of use and their current application to the job. Many employees are very experienced and do not need to refer to working instructions, but they should be in place for new employees and refresher training. Working instructions can range from procedures in text, large posters, small handbooks with pictures (e.g., what constitutes a nonconforming item or condition) to computer and video programmes. Don’t forget to take into account the environment in which the instruction will be used. A hi-tech office is going to be very different from a machine shop. Laminated posters are very useful for dirty environments. They also help with easy removal of graffiti!
Working instructions and all other quality records must be ‘legible to the product’. This means that pencil may not be used for records or any other instrument that would result in ambiguity. I remember on one contract that the Quality Manager assured me that all old (obsolete) files were safely stored away from documents currently in use. When I checked, I found they certainly were, but in cages in a dockside warehouse that was under attack by seagulls most of the time. Most of the files were in tatty boxes covered in bird plop and so were certainly not ‘legible to the product’. It took weeks to clean up the mess.
A good QAM will ensure that working instructions and procedures are available at point of use, are legible, in current revision status and accurately reflect what is needed to do the job. Having them in the right place at the right time will not do any good if they can’t be read because they’ve been eaten by rats or covered in flood water or dust. Paper records are still an important part of many business environments and should not be neglected in the haste to automate documents via technology.
Service industries often have a tough time applying the ISO standard to their activities. The Nonconforming product control requirement is an example . I have applied the Qualidoc procedure successfully for telephone service distributors, voice and data communication for a large pharmaceutical company and a research laboratory,
I have also worked with many marine companies, for example marine freight forwarding. They move paper or electronic documents round offices to move ships around the world; move pulp and paper from rail cars through warehouses on to ships.
For the marine freight forwarding company preparing for 1SO9001 registration I treated the documentation as the product. The process began with a Freight Engagement (the Contract) and ended with a Bill of Lading (verification for delivery).
I made sure the process worked smoothly and communication was watertight between all interested 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 through which it travelled,
The Certification Body’s assessor accepted this application of the standard and recommended certification. This procedure works well even though many of the documents are part of an automated flow. As long as the original quality system is thorough an automated system can be chosen and used more effectively.
Too often employees believe that the quality system is ‘management business’ and it is a shock when they discover that everyone is involved. I have found also that academic training centres (universities, training colleges) do not give sufficient credibility to quality management, particularly in their engineering and business development studies.
We do not want to wait to put this right until the auditor arrives from the Certification Body for the all-important certificate assessment. I encourage my clients to include training so that staff are aware of the impact of the quality system, as follows:
- know where to find the Quality Policy Manual
- know where to find the Quality Policy statement by the CEO
- can describe, in brief terms, what the Quality Policy means to them
- know where to find their copy of the Quality Assurance Procedures
- if asked “how do you know how to do your job?” will have an appropriate response in their own words, such as “I have xxx number of years as … I have xxx certificates and I have working instructions on the intranet.”
- can find their working instructions on the Master Document List (read only)
- can realise and explain the impact of their work on the service or product on which they are working, or for which they are responsible. This is critical, as it depends on staff understanding the nature of ISO9001 and its effect on their work. (A requirement of the standard and the assessor could ask this question).
I use my ISO Cheat Sheet to make this training less of an ordeal, and to prepare everyone for questions which are outside their normal range of activity.
Employees become accustomed to these questions.
|I.M. HAPPY COMPANY (IMH): ISO Cheat Sheet|
|How do we trace a part?|
- Work Order
- Inspection and Test Records
|Who is the Quality Assurance Manager? |
JOHN (or JANE) JONES
|What are the QAM’s responsibilities?|
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?
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 recognise a non-conforming part or condition?|
A part or condition which does not meet CUSTOMER or IMH specifications (receiving, in-process
and final inspection).
|What is the IMH Company Quality Policy and where is it kept? |
I can refer to the Quality Policy Manual and the Quality Assurance Procedures Manual in….(specify location).
|What does the Quality Policy mean to you and your job? |
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?|
ON THE (INSERT COMPUTER LINK HERE)
|Why do you need the Master Document List? |
To check forms, policies and procedures and make sure I have the latest revision.
|Who is responsible for keeping the Master Document List up to date?|
The Quality Assurance Manager.
Who is allowed to make changes to the documents we use?
ONLY the Quality Assurance Manager with the Quality Assurance Team and (where applicable) engineering, design et al.
EXTERNAL DOCUMENTS SUCH AS (INSERT EXAMPLE)
If I want to suggest a change to a form or procedure, What do I do?
GIVE suggested amendment, or draft of new form, to a member of the QUALITY ASSURANCE TEAM, who will pass it to the QAM.
|How do you recognise a Non-conforming Part? |
It is tagged with a ‘Non-conforming Item’ tag (INSERT EXAMPLE)
Do you have an assigned responsibility and authority for training new staff in company processes?
AS9116 can be a standalone requirement or an additional requirement to AS9100D, AS9110 (Aviation Maintenance Organizations) or AS9120 (Aviation, Space and Defense Distributors). It does not apply to ‘build to print’ contracts.
Source Control Drawings, Bills of Material, Manufacturing methods and Key components must be considered for their NOC status, i.e., design characteristics and performance requirements to the lowest levels in the supply chain.
The prequalification contract stage and all other contract review stages (which should be frequent) will need careful monitoring, with sufficient root cause analysis of nonconformances.
Thorough verification will be required at each design phase, such as Preliminary Design Reviews and Design Review Dispositions, before deciding whether or not an NOC is necessary and who needs to approve, for example:
- Changes that the customer must accept before implementation,
- Changes that may require customer acceptance before implementation
- Changes implemented concurrently with notifying the customer that acceptance is required.
So where should design approval representatives concentrate verification resources? I suggest start with the RFQ and its relation to the design history of current and previous contracts.
If a new contract emerges:
- identify at which level in the design NOCs are (or might be) required;
- by whose authority and responsibility they will be issued;
- resources involved (including supply chain);
- check current status of Master Document List (revision status of design documents);
- identify, establish and verify baseline configurations with the customer, with design change authorisation levels.
Bear in mind that Standards Boards are rejecting recommendations for certification where they consider that Nonconformance Reports with insufficient root cause analysis.have been signed off by Certification Boards.
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.
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
FROM: JEAN WHITE, QUALIDOC
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?
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.
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.
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.