PCML operates a fully ISO13485 and ISO9001 compliant Quality Management System – for the manufacture and assembly of Medical Grade Devices and a range of High-Tech and Scientific Instruments.
Our objective – to ensure consistent, repeatable, high quality products on time, at the most competitive rates, and to the highest specification, for all its customers.
Since its first accreditation in 2005, PCML has achieved continuous annual re-accreditation with zero non-conformities and seeks to continue.
Company-wide Quality Objectives
- 100% On Time Delivery
- 100% Conformance To Specification
- 100% Value For Money
PCML strives to utilize new business processes and system improvements tools. In recent years, our management team has intiatived many new initiatives including:
- PCML “Design For Profit” programme
- Development of an internal & external NCR monitoring, reporting and analysis system
- Dedicated QA Technicians at each site
- Formal Key Account Management Teams
- Separating work type and employees into categories A-C to improve the quality of workmanship and get the right job to the right machine at the right time
- Development of staff training programmes in line with A-C category work
- Customer training seminars
PCML have also invested in Preactor – one of the leading Manufacturing & Production and Capacity Planning software packages – designed specifically for companies who manufacture and assemble multiple products to specific customer order.
Preactor offers real time cost management and helps to increase on-time delivery performance, as well as creating a more productive work environment.
Answer: The Company controls its processes by identifying and planning all procurement, storage and manufacturing activities and the provision of a suitable working environment. The company ensures adequate provision of suitable tools and equipment and their maintenance, the provision of suitable trained and qualified personnel, the use of documented work instructions where their absence would impair quality, effective supervision and the maintenance of suitable records of any quality-related process.
Answer: Any product found to be non-conforming is clearly identified and documented procedures are followed to ensure that such product is not used until an appropriate disposal decision has been made. Where the proposed method of disposal would involve acceptance by the customer of the non-conforming product, the matter is reported, for concession, to the customer and the details of any concession documented. A detailed documented flow chart covering the above has been developed called “Quality Processes QP 09 Non-Conforming Product Procedure” and can be found in the Quality Processes manual. (Non-Conforming Product Procedure QP09)
Answer: Our continuous improvement objective is to ultimately achieve a 0% process reject rate.
Answer: Re-work is monitored and recorded on an individual basis and reported in the Internal Monthly Quality Data, All Customers report. The report contains information on the following:
- Non conformities by month annual rolling bar graph
- Individual rework details
- Action to rectify list
- YTD defect by cause bar graph
Re-work is estimated to be significantly lower than 1%.
Answer: Yes BS EN ISO9001:2015, with a circulation list of controlled copies to all key functions within the organisations, giving access to all employees and business partners.
Answer: The Directors of PCML are fully committed to reviewing and improving the quality of the service offered in the precision machining, assembly and finishing of components to customer drawings, to ensure customer needs and expectations are fully satisfied. The quality objectives of PCML include producing complete solutions to customers’ manufacturing needs from concept through to production in the most cost effective and efficient way and on time. PCML recognises that its continuing success and reputation depends on the quality of the service it offers and that BS EN ISO9001:2015 provides an internationally recognised standard for quality systems, against which PCML’s own quality System can be judged.
Answer: PCML Quality Processes cover the following key departments and functions:
- Company management
- Marketing including Sales
- Goods in/out
- Customer service
- Non conformance
- HR including Training
- Audit and management review
- Corrective & preventative actions
Copies of PCML Quality Processes are circulated to all key functions within the organisations, giving access to all relevant employees and business partners.
Answer: Management Reviews of the quality system are carried out at planned intervals and are identified on the Internal Audit Programme. The management review considers the overall suitability, adequacy and effectiveness of the quality system, including the setting & review of quality objectives and any opportunities for improvement. The company also maintains and operates adequate facilities and procedures for the identification, collection, indexing, filing, storage, maintenance and disposal of quality records. These records demonstrate achievement of the required quality and the effective operation of the quality system and include relevant sub-contractor quality records. Finally, external consultants BSI and KW Consultants are employed to ensure complete adherence to quality systems and procedures.
Answer: See Quality processes, QP 09, Non-Conforming Product Procedure (Non-Conforming Product Procedure QP09)
Answer: We Employ Lean Manufacturing to eliminate waste in all areas of the business.
Answer: ISO 9001:2015 Precision Machining & Assembly & Finishing Components To Customers Drawings. (ISO 9001:2015 Certificate of Registration)
Answer: Yes as part of our containment policy, which is detailed in our Quality Manual, 8/12, Corrective & Preventative action and Quality Processes, QP12 Corrective & Preventative Actions.
Answer: For our business, quality is a critical success factor to achieving a competitive advantage. Measuring the cost of quality is also essential in ensuring we obtain an acceptable return on investment. Conventional cost accounting systems do not appear to provide a true indication of the cost of quality and its impact on profits. Total and complete customer satisfaction is the ultimate measure of the return on the investment made in Quality. To measure the Cost of Quality we look at the necessary investment required in terms of capital plant depreciation cost, labour cost, materials cost, any rework cost and ultimately any cost of scrap, in order to achieve total customer satisfaction.
Answer: PCML has developed and operates a Continuous Improvement strategy, which focuses on ways of improving product quality and customer delivery times. To address the issue of improving product quality PCML continues to invest in the following:
- Personnel recruitment
- Process development
- Production capacity
- Employee training
- Customer training
We are happy to discuss our quality improvement plans with you in more detail.
Answer: PCML carries out a programme of planned and documented internal quality audits to test whether quality activities comply with planned arrangements and to determine the effectiveness of the quality system. The internal audit programme is prepared and carried out by suitably trained internal quality auditors. Written reports of relevant audits are prepared and copied to personnel with responsibility to initiate or control appropriate action. (Internal Auditing Procedure QP11)