“WHAT IT IS. WHAT IT DOES”
PROVEN BEYOND REASONABLE DOUBT
Quality Defence has gradually replaced, or should we say included? the conventions of Quality Assurance. We all recall our heyday in the 70s when we could talk about Quality Assurance and the BS5750 Standard which provided us with the template for a quality management system. This encouraged the idea of “Assuring” the quality produced to an agreed specification, and our role was that of the “Assurer” but now we need to maintain due-diligence for the claims we make about our Quality, and this has become the new role of the Quality Manager and the Quality Department.
The position of Quality Management Representative is now replaced by the term “Quality Steward” and “Quality Stewardship” these suite, our newfound responsibilities very well as being the trustee and guardian of the work done by others for its correctness, use and placement in safe keeping with traceability for subsequent recall when needed for the Defence of Quality.
The passage from Quality Assurance Systems to Risk Based Thinking can be traced through the changes with the alignment to European and International standards which started in 1987 when the International Organization for Standardization (ISO) adopted the concept of a global standard for quality management systems in ISO9001 and dropped the word “Assurance” from the specifications title. As a result, subsequent revisions have introduced the process based quality system PDCA, continuous improvement directives TQM and now a quality standard dedicated to Risk Based Thinking.
During this imposed maturity progression, we lost the identification of being a profession dedicated to Assurance of Specification, and have struggled to redefine our profession in which “Quality” has any meaning.
“Quality Defence” is proposed to correct this problem by incorporating all that has gone before in defence of that which we hold sacred namely “Compliance” in whatever application or vocation we aspire to achieve. With the introduction of “Risk Management” and Risk Based Thinking” as a specified requirement of our Quality System Standards, we are now called upon to explain and defend, statements our organizations make relating to “What IT IS and What It DOES Proven Beyond all Reasonable doubt” in order to provide the decision makers and risk takers in our organisation with the due-diligence they seek and will undoubtedly need in the future.
The concept of Quality Defence has 5 main contributors from which a defence of the quality can be presented:
The methodology and program for the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met.
Planning and application of stage and final measurements to confirm and ensure conformance to specified requirements or to segregate that which is non-conforming.
Verification by acceptable means of the correct specified process, product, service or occasion, quality attributes and advantages.
Management and control of actions taken within an organization to increase effectiveness and provide added benefits to the organization, stakeholders, customers and other known interested parties.
Management and influence of all quality related processes and factors that can improve or put at risk the realisation of an agreed or desired quality of products and service.
Note: The above definitions are selected, modified and developed not only to assist in the concept of Quality Defence but also to incorporate a number of dictionary and authorities’ own definitions as well as avoiding infringement of copyrights.
Due-Diligence for Quality.
“What IT IS and What It DOES Proven Beyond all Reasonable doubt”
The proof of due-diligence is a major factor in the defence of quality. This is strengthened by commitment and competence, experience and knowledge, and having proven management systems that are used in the administration of the business.
Product and Service Integrity and Provenance
The defence of quality also calls on the correct application of proven and compliant planning and procedures, effective and responsible risk management supporting a robust and well maintained quality management system responsive to challenges and litigation for the tasks and requirements it is called upon to perform.
The robust nature of the quality management is assured by the correctness and availability of the correct equipment, resources, documents and data.
Product and Service Conformance when challenged, needs collateral to support the claim of correctness. This is critical because it will be tested and the more robust the defence, the greater opportunity there will be to challenge accusation or counter claims of insufficient occasion quality.
This collateral proves the integrity of the product, service or process and is essential in the Defence of Quality.
This provenance of product, service or process is evidenced through process and quality control for which records are needed to demonstrate compliance with designs licences and permissions (e.g. Specifications and Tolerances) traceable to the specific property in the product and correlation or configuration with its title and identity.
All of the above will need to be demonstrated by way of undisputable records for each occasion that can be challenged, and must be traceable to a recorded position in time and event.
ISO9001:2015 Quality Management Standard
Compliance with the international quality management standard when proven, should afford a degree of due diligence for the management of quality, but will not provide for any challenges to the quality of the management itself. Nevertheless, the 3rd party assessment of the organisations management system shows “intent to be correct” and to have that intent challenged and verified by the Certifying Body engaged for that purpose.
In addition, we should be able to look to the CBs (Certifying Bodies) assessment against the requirements of the revised standard ISO9001:2015 and in particular the clause on Risk Management in order to claim due-diligence for a decision on risk. This was first raised by David Hutchins in a debate earlier in the year on Risk Management and the initial posting stated that
“The word Risk is new to ISO 9000 and paradoxically it brings with it risks of its own. As I have repeatedly said elsewhere, we are now straying into the field of Product Liability which also includes the field of Product recall and recently we should all be aware of the connotations of that. I am suggesting that Quality Professionals must study relevant case law to see where this is taking us. I will refer to just a few cases that are well documented and most are on the web.
Grant vs Australian Knitting Mills Ltd,
Donoghue v Stevenson,
Larsen v General Motors Corporation (what constitutes a 'foreseeable circumstance',
Vacwell Engineering Ltd v. B.D.H. Chemicals Ltd 'reasonably foreseeable circumstances”.
The debate agreed that when a system has been found to be compliant we will have determined the risks and opportunities that need to be addressed that are proportionate to the potential impact on the conformity of products and services. If this is verified by our own internal audits, and validated by a 3rd Party assessment body, the CB could be held jointly accountable.
Taking this further it is not unreasonable to claim that having applied the practices that have been verified, if a risk was taken in due-process and it resulted in the financial failure of the organization, the creditors and shareholder who had invested in good faith and relied on the CBs registration and certification could seek compensation.
Product Verification and Validation
ISO10005:2005 the international standards guide for quality planning, being a guide provides little by way of due-diligence when adopted for the purposes of Product or Service verification. Most legal and statutory instruments recognise conventions in part as showing intent when it can be demonstrated that the guides recommendations have been fully understood and applied, but this is not as conclusive as complying with a standard that specifies what is required and necessary for the correctness and integrity of a product or service.
Having the product independently verified and validated as part of the quality plan by an accredited authority or laboratory in accordance with recognised national or international standards provides independent confirmation of correctness for the sample provided.
Doing so shares the risk and should afford a degree of due diligence for the quality of the product on the occasion presented. It will still fall on the design authority and manufacturer to ensure and prove all subsequent products were identical or compliant with the tested sample for which both process and quality control practices need to be maintained and in good order.
Having the tests and practices attended and overseen by an independent certification authority supports the defence of quality and further demonstrates due-diligence for the occasion in question. European Standard EN 10204:2004 covering Metallic products - Types of inspection documents have some degree of merit in this subject but it is limited to metallic materials.
Physical Dimensional Inspection can be verified by the standards for First Article Inspection FAIRs for which sector scheme standards such as AS9102 are supportive and widely used to demonstrate process capability and product conformance with designs prescriptions, licence and property.
The ‘CE Marking’ conventions employed throughout the European Community have recognised the need for manufactures to verify their products and also assist in providing directives for product verification when traded in the European Economic Area (EEA). This places an obligation on the manufacturers to provide a Quality Defence for the product and signifies that the product has been assessed to meet all relative safety, health, and environmental protection requirements.
It is regrettable that there are currently no similar universally recognised standards for the practice of product verification, and we have to rely on the tests section prescribed within the product standards themselves for verification planning and management as well as directives on product measurement.
BMQS9000:2015 Business Management Quality Standard.
The Business Management Quality Standard probably contributes most to Quality Defence when correctly implemented, audited and found to be compliant. The standard is specifically directed at providing those empowered to make strategic decisions with due-diligence by providing the decision makers with a planned, informed and defendable position at all times.
To justify decisions that favour one set of stakeholders to the detriment of others, requires an informed and defendable position, traceable to the facts and figures available on the occasion in question, so the decision can be defended at a later stage when questioned.
This standard is directed at a prescription so that organisation can compare their achievements with what is expected of its management. Unless the business management quality is suitably measured and continually improved, the process by which goods and services are provided cannot themselves be assured for best practice and stewardship of its stakeholders' investments.
The Business Management Standard cannot by itself provide failsafe guarantees that it will prevent events resulting in unforeseen financial losses or social discredit. At the same time, the establishment of an efficient internal control system centred on financial business administration, integrity and accurate accounting practices reduces the probability of such losses, and affords a degree of due-diligence to its decision makers and executives when proven by assessment under the offices of a suitably experiences and accredited assessment body.
The quality of the management and the management of the business activity which facilitates the completion and distribution of its goods and services is a concern that has not been suitably addressed in the Quality Management Standards ISO9001: 2015 or its industrial derivatives and this needs to be addressed.
Summing Up for the “Quality Defence”
Defending our claims about the quality of product and service our organisations produce has always been the prime task of the Quality Departments, practitioners and authorities in the company. Historically this has been done by testing and inspection, in order to remove those products that do not conform from inadvertent release to the customer or markets.
Latter with the advent of Quality Assurance we sort to defend the products from poor quality by introducing systems and management practices that were intended to prevent their manufacture in the first place schooled by the teachings and philosophy of Joseph M. Juran and Edwards Deming.
Subsequent changes and improvements in each revision of the Quality Management Standard and the publication of likeminded standards for environment, social accountability, business continuity and occupational safety has introduced new concepts and tasks but the loss of the word “Assurance” from the standards title in 1987 has left the standards subject and purpose open to varied and often conflicting interpretations as to what the responsibilities of the quality practitioners actually should be.
This new ISO9001:2015 standard introduces many new considerations, a little short on directives, but an abundance of tasks. As such we need to consider just exactly what our role is as Quality Practitioners and redefine our relationship with Top Management and the organisations that employ our services.
Although Quality has to meet a customer’s requirements to have a market, it is inept in this litigation biased society to rely on the trust between the customer and supplier without considering the possibility of litigation in the event of benign failure.
I do hope this article will stir interest in the subject of Quality Defence which incorporates all that has gone before and now presents the Quality Profession with new tasks of advocate, stewardship and council as well as protectorate and I sincerely and passionately believe those with common sense at their disposal will reach the correct decision.
It’s our job as Quality Stewards to defend the quality our organisation provides and we need to accept that reasonability and get on with it.
Godfrey Partridge Q-Share LLC CEO and President.