Quality management systems developer
If an organisation has an effective quality management system (QMS) it is able to
- provide the right product or service every time
- identify problems or potential problems
- make improvements
It also means the organisation can put a certificate on the wall to say it has a QMS approved by a certification body and sell to customers for whom this is a requirement.
The certificate on the wall should not be the primary reason for implementing a QMS. It leads to an attitude where the organisation does the minimum to meet the requirements of ISO 9001, but they avoid making changes to their processes and complying with the standard becomes a burden.
To gain real benefit from a QMS it is necessary to review the processes of the organisation, look for risks and opportunities for improvement, and simplify the processes to avoid errors.
- Documentation should be reduced to the minimum necessary to ensure requirements are met. The current version of each document must be available to personnel who need to use them.
- Relevant records must be made available to management for review and analysis, so that opportunities for improvement can be identified.
A new version of ISO 9001 was introduced in September 2015.
The new standard does NOT require the QMS documentation to include a quality manual and procedures. It DOES require each organisation to:
- determine external and internal issues that are relevant to its purpose and its strategic direction,
- establish and document the scope of the QMS
- identify the processes of the QMS and establish documentation to support the processes.
For further information on reviewing and simplifying the QMS go to ISO 9001:2015
The Internal audit process includes:
- Planning audits for the year, taking into consideration the importance of the processes, changes affecting the organization, and the results of previous audits
- Preparing and approving audit checklists
- Following up audit findings and taking corrective action as appropriate
- Reporting audit results to management.
From my experience as an internal quality auditor I know it can be difficult for any organisation to conduct audits on the planned date, or find personnel who are sufficiently qualified and impartial to conduct the audits.
For further information on training internal auditors, preparing checklists, conducting audits or reviewing audit findings go to Quality audits
The Purchasing process requires evaluation of suppliers, this may include visits to supplier’s premises and review of their manufacturing processes to confirm capability of equipment and personnel. Surveillance visits may also be required during the manufacturing process or to witness final test.
If you need assistance with internal audits, supplier evaluations or surveillance visits contact us.
Experience and Qualifications
In February 2012 I took an IRCA approved ISO 9001:2008 lead auditor course, to improve my knowledge of the standard and help me understand how it is interpreted by certification bodies.
The course was provided by ISOQAR, it focussed on
- Quality principles on which ISO 9001 is based, their relevance to the clauses of the standard, and their application within different types of organisation
- Audit process, including development of checklists, conducting audits against the standard
- Judging and reporting non-conformities
In September 2015 a new version of ISO 9001 was published. Each organisation approved to ISO 9001:2008 has 3 years to review their QMS and make changes required by the new standard. Because the changes are quite significant each auditor also requires additional training to be able to conduct audits against ISO 9001:2015.
I had been reviewing the changes to ISO 9001, attending courses provided by BSi and CQI, and considering how they would affect the QMS, since the first draft was published in June 2013 so I was familiar with the new standard.
In December 2015 I attended the Transition Training course (with ISOQAR). The course covered the new and changed requirements and it included a simulated audit of a small company approved to ISO 9001:2008 to determine whether it met the requirements of ISO 9001:2015.
After completing the ISO 9001:2015 Transition Training I started working for AA Certification as as quality systems auditor (in addition to providing a quality management consultancy service for my clients).
For further information about the changes to the standard for quality management systems go to page ISO 9001:2015
After completing the MSc course I joined Miko Oilfield Supplies, a design company in Shipley specializing in mechanical handling equipment for the offshore oil industry. They were implementing BS 5750 (assisted by a grant under the Enterprise Initiative) and they needed someone to maintain and develop their quality system.
I applied for membership of the Institute of Quality Assurance (IQA), and I was accepted in 1992 on the basis of my academic qualifications and experience.
The IQA was granted a Royal Charter in 2006, and changed its name to the Chartered Quality Institute (CQI). My membership was upgraded to Chartered Quality Professional in 2014, this requires a thorough understanding of key elements of the CQI competency framework:
- Governance – Operational frameworks, policies, processes and plans, are relevant to organisational and stakeholder requirements
- Assurance – Ensure policies, processes and plans are effectively implemented, and all outputs are consistent with requirements
- Improvement – Facilitating a culture of evaluation , learning and improvement which support business strategy, enhance reputation and increase profitability
- Context – Determine external and internal issues relevant to its purpose and strategic direction, and affect its ability to achieve intended results
- Leadership – Maximising the influence of Quality Management to develop a culture of evaluation and improvement throughout the organisation.
To maintain my status as a Chartered Quality Professional I must also plan and maintain records of continuing professional development.
MSc Manufacturing Systems Engineering
I returned to Bradford in 1990 where I had an opportunity study Manufacturing Systems Engineering. The course focussed on mechanical engineering but it included design, planning and management methods applicable in many different situations:
- Poka Yoke – Foolproofing, preventing errors, designing a product or process so the easiest way to do it is the right way
- Kaizen – Change for better, continual improvement of the product or process
- Just in Time – Making only what is needed, when it is needed
These terms were originally used by Toyota (in Japan) when they applied quality control techniques to their production system, leading to significant quality improvement and cost reduction during the 1960’s and 70’s.
The course included an industry based project. I worked with Dracup Jacquards, a textile machinery manufacturer in Bradford, performing a feasibility study for a BS 5750 part 1 (ISO 9001) quality management system and preparing a quality manual.
IQA membership exams
I first worked in quality control at G Barraclough (soft drinks) in Bradford (1981-83) testing each batch of product prior to bottling and checking output from the production lines. After moving to the south coast I worked in the materials testing lab at Marconi Space Systems, Portsmouth (1984-88). At Marconi the quality system was approved to BS 5750 part 1 and some of my colleagues were members of the Institute of Quality Assurance (IQA). I wanted to find out more about quality (as a profession) so I enrolled at the local college for the IQA courses in metrology (dimensional measurement not weather forecasting), statistics, and management.
After leaving Marconi I worked as a goods inwards inspector for Harben Systems (Flowplant) a manufacturer of high pressure pumps and water-jet cutting equipment in Salisbury. My role included mechanical inspection of machined components, and I introduced a sampling plan to establish appropriate inspection levels for each batch.
Science and Society
I graduated from Bradford University in 1981 with a B Tech in Science and Society. The course looked at how advances in scientific knowledge led to social change, and how changes in society drive technological development. At the time early personal computers (such as the BBC Micro) were just coming on the market and it was clear that we were on the cusp of a new industrial revolution which would be as significant as the use of steam to power factories in the 1800’s. We needed to prepare for these changes so that they would benefit society as a whole.