Corrective & Preventive Actions
Version: 04
Page: 2 of 5
WORK INSTRUCTION Issue Date: 17 January 2001
Authorised by: Marjorie Dickenson
1. PURPOSE
The purpose of this procedure is to ensure continuous improvement by a systematic approach to planning and taking corrective and / or preventive action.
2. SCOPE
This procedure applies where actual or potential non-conformances have been detected, or where an opportunity for improvements has been highlighted.
Any action taken will be appropriate to the extent of the problem / opportunity, and the degree of risk encountered.
3. REFERENCES
AS ISO/IEC 17025:1999 – General requirements for the competence of calibration and testing laboratories – Sections 4.10 & 4.11
ISO 9001:2000 - Clause 8.5
Deming, W. Edwards. Out of the Crisis: Quality, Productivity and Competitive Position. Cambridge University Press, Cambridge, Massachusetts, USA, 1986.
Work Instruction – Control of Non-conformity
Work Instruction – Internal Audits
Work Instruction – Management Review
Form – Corrective & Preventative Action Request (CAR)
Form – Corrective & Preventative Action Request (CAR) Register
Form – Customer Complaint
4. RESPONSIBILITY
Managing Director / · Monitor customer satisfaction of SimuLab P/L serviceLaboratory Manager / · Monitor customer satisfaction of SimuLab P/L service
Customer Service personnel / · Monitor customer satisfaction of SimuLab P/L service
Quality Assurance Manager / · Register Corrective Action & Preventative Requests
· Arrange follow up audit or check of action taken
· Monitor customer satisfaction of SimuLab P/L service
· Monitor technician efficiency
· Prepare QC report for major contract clients
Other managers / · Determining, managing and confirming corrective / preventive actions
All personnel / · Raising Corrective Action & Preventative Requests
· Performing corrective / preventive action where delegated to do so
· Refer any customer complaints to the Quality Assurance Manager
5. ACTION / METHOD
SimuLab recognise that the performance level of most processes show a tendency to decrease over time unless actions are taken to maintain it. Whilst to simply maintain the current standards, it is necessary to perform some degree of maintenance, SimuLab as outlined in its quality policy and objectives is committed to creating continuous improvements wherever possible.
Simulab has embraced a multifaceted approach to ensuring continuous improvement. Our improvement model is based on the principles of the Deming wheel, a cycle of plan, do, check and act.
· Key performance indicators that are critical to the success of our business have been identified by management and will be monitored on a continuous basis.
· Internal audits will be used by Simulab to evaluate whether the management of business and operating processes are in accordance with stated policy and objectives.
· Customer feedback in the form of both customer complaints and satisfaction confirmation will be used in the evaluation process.
· Management reviews will be used to identify and monitor improvement actions and to evaluate outcomes against company objectives.
· Third party accreditation audits will confirm continuation of AS ISO/IEC 17025:1999.
Non-conformance and performance gaps will be addressed with Corrective & Preventive Action Requests (CARs).
5.1. Evaluation of Key Performance Indicators
5.1.1. Routine Quality Control
SimuLab has established a quality assurance program to ensure that there is sufficient quality assurance activities undertaken within the laboratory that test results produced and reported to customers are defensible at law.
The routine elements used by SimuLab’s quality assurance program to monitor performance and enable the laboratory to improve the quality of its test results include:
· Sample blank.
· Spike Recovery (accuracy).
· Surrogates (accuracy).
· Certified Reference Materials (CRM) & in-house standards (accuracy).
· Field duplicates (if sampling undertaken by SimuLab P/L) – (precision).
· Sample replicates – (precision).
5.1.2. Sample Turnaround Times
A critical factor in customer satisfaction is sample turnaround times. SimuLab will monitor the sample turnaround times in the Environment Laboratory, Microbiological Laboratory and Minerals Laboratory on a representative sample of SimuLab’s routine tests. Additionally, SimuLab will monitor sample turnaround times for sample batches for major contract clients. Eight (8) tests have been selected:
· Determination of BTEX Compounds by GC/FID with Purge & Trap Concentration.
· Determination of PAH’s in Soils, Solid Wastes and Groundwater by GC/MS.
· Determination of pH.
· Determination of Metals and Trace Elements by ICP-AES (USEPA 200.7).
· Toxic Characteristics Leaching Procedure (TCLP) – (USEPA 1311).
· Microbiological Estimation of Raw and Drinking Water for Total and Faecal Coliform by MPN Technique.
· AAS Analysis of Geochemical Samples following a Total Mixed Acid Digest.
· ICP-AES Analysis of Metals in Geochemical Samples following a Perchloric Acid digest.
The eight (8) routine tests selected are deemed “representative” in that they are high volume items.
Turnaround time is defined as the time taken from when sample batches are booked into the LIMS until results are reported to the customer.
5.1.3. Production Efficiency
The efficiency of technicians within the laboratory area will be monitored by:
· Set production targets for all analytical processes i.e., fire assay weigher to weigh a minimum of 500 paying fusions per shift. These operating objectives have been set at a level that will not compromise quality.
· Number of repeat samples due to quality control failures within sample batches.
Due to the nature of laboratory technician work, this monitoring function will need to be conducted over an extended period, so that the data collected is truly reflects efficiency.
5.1.4. Quality Control Performance
Quality Control reports will be produced for major contract clients at the end of each month. These reports will consist of the following information:
· Shewhart control chart for internal standards submitted with sample batches.
· Cusum chart for the standards which is an indicator of bias.
· Thompson/Howarth scatter plot - labelled analysis of replicate samples.
These charts/plots can be readily produced by the laboratory information management system InfoLAB.
Naturally the laboratory will monitor analytical performance of each analysis batch and section supervisors and technicians will ensure that all quality control samples meet acceptance limits as specified in laboratory methods.
5.1.5. Tenders and Quotations Converted to Contracts
Analysis contracts are clearly pivotal to the ongoing success of SimuLab. As part of the self- assessment process, SimuLab will evaluate the percentage (%) of major tenders and quotations (>$10,000) that are converted to contracts. Such information is vital in the “system solutions” section of our company. Based on information gathered as to why tenders and quotes were not converted to contracts, weaknesses can be identified and areas that need improvement identified.
5.2. Customer Complaints
All customer complaints, whether written or verbal are to be entered on a Customer Complaint form available from the company intranet, Quality Assurance Manager or the Customer Service Unit. All customer complaints are to be the subject of a Corrective & Preventive Action Request (CAR). By formalising our customer complaints, we can monitor/ensure that effective corrective action is taken and improve our processes, thereby reducing the likelihood of recurrence.
Customer Complaints forms are to be attached to the relevant CAR and filed by the Quality Assurance Manager.
5.3. Management Review
Senior management periodically reviews the operation of the Quality System to ensure that it remains relevant and effective in controlling the quality of the company’s services. The review is a desktop one, covering all audits, CARs, customer complaints and any other aspect of the Quality System for the period defined in the Review Report. See Work Instruction – Management Review.
5.4. Corrective and Preventative Action Request
5.4.1. What are, why raise and who raises Corrective and Preventive Action Requests (CARs)
The corrective and preventative action process is the method by which SimuLab handles the correction of non-conformance, improvement of processes and conditions, customer complaints, items arising from audits, ensuring inappropriate test methods are not used and any other problems found in its day-to-day operations.
By committing to raising a CAR, we formalise the process. This ensures that the Quality System has a record of the action required and that one or more staff members are assigned the responsibility to follow through action.
Any SimuLab staff member can raise a CAR and put it into the system. For example:
· Section supervisor and/or technician where a problem may keep recurring.
· Customer Service Unit, Section Supervisor and/or technician when goods received from a supplier are damaged, faulty or do not conform to specification.
· Customer Service Unit when a customer complaint is received.
· Quality Assurance Manager when a non-conformance is detected during an audit.
· Employee who considers an operational improvement or correction is needed.
5.4.2. Raising a Corrective and Preventative Action Request (CAR)
A CAR is initiated by filling in Part 1 of the form Corrective and Preventive Action Request (CAR). As previously stated, these are available from the company intranet, Quality Assurance Manager or the Customer Service Unit. The relevant sections of Part 1 are completed and forwarded to the Quality Assurance Manager or authorised delegate to be registered in the CAR register. The next sequential number is assigned to the CAR for CAR register purposes.
5.4.3. Procedures to be followed after the detection of non-conformance, departures from documented procedures or where improvement is needed
The CAR is then passed on to a Laboratory Manager, the Section Supervisor or delegate for affirming that further action is required. In consultation with relevant personnel, senior management will determine the specified action required. Part 2 of the form Corrective & Preventive Action Request (CAR) is then completed and an appropriate staff member assigned the responsibility [communicated] of ensuring that the required action is taken by the agreed completion date.
That staff member then completes Part 3 recording the action taken, and measures taken to ensure that the non-conformance will not recur.
5.4.4. Closing out a CAR
The Quality Assurance Manager will then review the CAR and, where deemed appropriate, arrange for a follow-up internal audit or check to be carried out to confirm the effectiveness of the action. This will be after enough time has elapsed that allows for the actions to be fully carried out.
The results of the follow-up audit or check shall be noted in Part 4 of the CAR by the Quality Assurance Manager and the CAR register entry will be completed either by:
· a sign-off by the Quality Assurance Manager where satisfactory; or
· with the CAR No. of a new CAR raised, where outcome is “unsatisfactory”. The outlined corrective action process will then be repeated where unsatisfactory results are returned.
The Quality Assurance Manager or delegate will then file the Corrective Action Request (CAR) in numerical order.
5.5. Customer Feedback
In order to compete effectively SimuLab recognises that companies must develop processes that provide them with a comprehensive understanding of the current and future requirements of their customers. Companies that attempt to stay informed about customer preferences, obtain feedback from customers, and ultimately develop a relationship of trust, are more likely to be able to anticipate changes in demand, gain goodwill, develop creative solutions to meet final customer needs, and use customer practices as a source of competitive advantage.
Measuring customer satisfaction means transforming a subjective process into a more objective one. One key approach is to measure customer satisfaction on three levels:
· Quality of analytical results from SimuLab.
· Ability to meet agreed sample turnaround times.
· Strength and consistency of the relationship with the SimuLab over time.
Measuring on these three levels provides a well-rounded view of the customer’s experience with our company.
SimuLab has implemented a “Listen and Learn” strategy to build customer relationships and to proactively ensure their satisfaction. On a monthly basis customer comments (both positive and negative) are systematically documented by Customer Service personnel, Laboratory Manager, Quality Assurance Manager and the Managing Director. This data is analysed on a quarterly basis by the Quality Assurance Manager and results distributed to senior management.
Listen and Learn Strategy 1 – Customer Service Personnel: SimuLab assigns Customer Service personnel responsibility for managing customer enquiries and needs. The Customer Service personnel acts as the first line (“eyes and ears”) for the customer, to address customer’s needs and help diffuse small issues before they escalate into complaints or areas of customer dissatisfaction. Customer Service Personnel must proactively meet and exceed customer’s needs.
Listen and Learn Strategy 2 – Senior Management Team: The Senior Management team builds close relationships with customers by making regular visits to customer sites and offices, these visits gain SimuLab customer knowledge. Senior Management team personnel can bring the full power of SimuLab to bear on customer problems.
Listen and Learn Strategy 3 – Formal Customer Reviews: A formal process by which we gain insight into our customer needs, assess their satisfaction and address their issues. At the heart of this process is the quarterly collating and analysis of data by the Quality Assurance Manager. Data is collected from Customer Service personnel, Laboratory Manager, Quality Assurance Manager, Managing Director, customer complaints and Corrective & Preventative Action Requests. This review process provides both quantitative and qualitative assessment of our service, estimate of our customer’s level of satisfaction and key customer requirements for projects and services. Additionally by analysing customer complaints, repetitive complaints will be highlighted and we can work towards reducing/eliminating recurring customer complaints
Customer satisfaction results provide vital information for understanding customers and the marketplace. In many cases, these results and trends provide the most meaningful information, not only on customers’ views but also on their marketplace behaviours – repeat business and positive referrals.
Customer Service personnel, Laboratory Manager, Quality Assurance Manager, Managing Director are required each month to assess customers’ satisfaction level utilising a scale of 1 to 5, with 5 representing a customer that is completely satisfied with SimuLab service, while 1 represents a customer that is dissatisfied with SimuLab’s performance in all areas. Complete the Customer Feedback Report form and hand it to the Quality Assurance Manager to analyse. Analysis of these customer feedback reports is pivotal to our continuous improvement process.
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