ISO 9001 Quality Manuals

Posts Tagged ‘Continuous Improvement’

Clause 5.6.1 Management Review General

Regular Management reviews should be conducted in order to assess the effectiveness of the Quality Management System and to continually improve. The management review should be a formal analysis and review of the quality policy, quality objectives and quality management system performance which generates plans for corrective action, preventative action or opportunities for improvement all of which should be documented in the management review minutes.

Clause 5.6.2 Management Review Input

The first item on the management review agenda really should be a review of the Quality Policy to confirm it is pertinent to the quality management system and organisation or if any changes are required. Similarly the Quality Objectives should be reviewed and updated as necessary. There should be a review of the Management Structure and any changes and confirmation that there is adequate quality management system resource.

The meeting should cover the minutes and follow-up actions from previous review meetings and confirm actions to improve the quality management system as a result of the review have been completed.

Findings of internal and external quality management system audits should be reviewed and outstanding non-conformances as a result of internal and external quality management system audits discussed. The Management Representative should conduct a trends analysis of the results of internal and external audits to present to the meeting. The management review team should also ensure that internal quality management system audits have been carried out as planned. Adverse trends such as an increased number of non-compliances should be identified and corrective action proposed. The results of third-party quality management system audits should be thoroughly scrutinised as these represent and independent view of the organisation.

The Quality Manager should present a trend analysis of Customer Complaints. This data should compare year on year performance especially when a product or service is seasonal. Volumes should be factored into the complaints analysis and so complaints should be presented taking this into consideration. Complaints are should also be categorise into critical and non-critical. Non-critical and total complaint analysis is useful for trends. Critical complaints should be closely analysed to determine if there is a common cause and if effective corrective action has been taken.

A standard format is to compare complaints per million units sold for each product. Industry standard complaint levels should be used for comparison. Again trends should be identified and if necessary plans for preventative action taken. Complaint analysis should also give an indication of opportunities for improvement of the quality management system. At this stage Safety incidents, recalls or withdrawals should also be reviewed. Corrective Action should have already been taken to deal with the causes of these incidents, the meeting should review the effectiveness of the quality management system in eliminating the cause of the incidents and also consider any common factor to the incidents in order to assess if preventative actions are required to improve the quality management system.

The meeting should review the quality management system Approved Supplier Register. A review of annual supplier performance should be presented normally by the Purchasing Manager. The report should include items such as percentage on time deliveries, percentage order completion, any non-conformances such as damaged deliveries or non-conforming products supplied plus any products rejected or accepted under concession. The report should also recognise exceptional supply performance and added value assistance received from suppliers as this should be factored into the quality management system when renegotiating contracts. Corrective Action plans should be formulated to deal with or change poor performing suppliers. Similarly to Customer Complaints, Supplier complaints should be analysed for trends.

The management review meeting should discuss quality management system process performance and confirm that the correct performance indicators are being monitored. Review and analysis of the quality management system Key Performance Indicator trends should be conducted to see if there is a visible improvement in performance. Sales levels should be one of the quality management system Key Performance Indicators as this will give an indication of company performance in the market place. Also the number and performance of new products successfully launched into the market place should be discussed. Again corrective action, preventative action and opportunities for improvement of the quality management system should be considered from the key performance indicator trend analysis.

The management review should cover the status of corrective and preventive action and compare numbers since the previous review and consider if the quality management system corrective and preventative actions are being completed in a timely fashion.

There should conduct a review of changes within the organisation and how this may have affected resource requirements including infrastructure, work environment, personnel and training requirements. At this stage proposed changes should be discussed and again quality management system resource requirements identified.

Review should also include Environmental performance and incidents,
and Health and Safety performance and accidents

Clause 5.6.3 Management Review Output

The Management Review outputs should include resource requirements corrective and preventative actions identified as a result of analysis of the quality management system review inputs, all of which should be clearly documented in the minutes.

There will also be opportunities for Improvement in quality management system effectiveness including product related customer requirements, change or elimination of non-productive elements, change or elimination of non-productive systems or procedures and supply of resource needed for improvement plans.

The results of the Management Review meetings should be documented in the minutes of the meeting and include a summary of all quality management system review inputs and outputs. The Management Representative should ensure the minutes of the Management Review meeting are distributed and effectively cascaded within the organisation.

HACCP is the acronym for Hazard Analysis Critical Control Point.  The concept was originally developed in the 1960’s by NASA to ensure food safety for the manned space programme. The Pillsbury Food Company in association with NASA developed the first HACCP programme for astronaut food. Pillsbury presented it at the first American National Conference for Food Protection in 1971. The Food and Drug Administration (FDA) in the US liked the HACCP programme and had Pillsbury assist them with it – it was first applied to low-acid tinned food in 1973. HACCP has gradually made its way around the globe since then. HACCP is managed globally by Codex Alimentarius. Its primary aim is to prevent food safety problems and effectively control food borne disease. The principles of HACCP can be used for all product and hazard types.

The Hazard Analysis Critical Control Point (HACCP) system is internationally recognised as the most effective method of ensuring food safety. 

HACCP is a system, which identifies specific hazards and implements measures for their control.  HACCP’s systems are developed using the seven basic principles detailed below:

Principle 1
Prepare a flow diagram of the steps in the process.  Conduct a hazard analysis by identifying potential hazards.  Assess likelihood of occurrence of these hazards and identify control options

Principle 2
Identify the Critical Control Points in the process using the decision tree

Principle 3
Establish critical limits, which must be met to ensure each Critical Control Point is under control

Principle 4
Establish a monitoring system to ensure control of the Critical Control Point by scheduled testing or observations

Principle 5
Establish the corrective action to be taken when monitoring indicates that a particular Critical Control Point is moving out of control

Principle 6
Establish documentation concerning all procedures and records appropriate to these principles and their application

Principle 7
Verify that HACCP is working effectively

On the 29 April 2004, the European Parliament and the Council issued Regulation (EC) No 852/2004 on the hygiene of foodstuffs.
Article 5 states that: Food business operators shall put into place, implement and maintain a permanent procedure based on the principles of hazard analysis critical control points (HACCP).

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I am a great fan of fantasy football so, tongue in cheek, I have applied principles of the ISO 9001 standard to our Fantasy Football League.

Our Fantasy League’s quality policy is to provide a competitive product and services of the highest standards of performance and reliability. By achieving this goal the League will consistently satisfy the needs and expectations of our customers and friends.

To ensure success of this policy League Management are directly responsible providing organisation and support, equipment and facilities, training and education of all members, reviewing and auditing performance, and driving continuous improvement in our own teams.

The League Management’s Quality Objectives are:

a)   To maintain an effective League Management System complying with International Standards if possible

b)   To provide a competitive product and services of the highest standards of performance and reliability, thus enhancing the League’s reputation with customers and friends

c)   To ensure compliance with relevant customer, statutory and regulatory requirements. (The Rules)

d)   To endeavour, at all times, to maximize customer satisfaction but still win all the prize money ourselves

e)   To pro-actively promote and encourage a culture of continuous improvement for our own teams within the league whilst at the same time recommending disastrous transfers to other members

The Fantasy League League Website provides control of documents (Clause 4.2.3), records (Clause 4.2.4) and the rules. External Document Control (Clause 4.2.4) was provided by OPTA statistics as these were approved as the authority to judge player performance by the League Management.

Team scores on a weekly basis were subjected to Internal Audit (Clause 8.2.2) a record of results and follow up actions were documented.

 Management Commitment (Clause 5.1) was demonstrated spending precious time watching every game available, Customer Focus (Clause 5.2) was intense, especially as we wanted to beat all our customers and run off with the prizes.

There were many painstaking hours of Planning (Clause 5.4) taken in preparation for the weekend’s games: who was on form? Who was injured? Who was playing who? Again corrective action was required: I need to get rid of Bramble he’s a liability and Wigan’s defence is leaking goals like a sieve!

Responsibility & Authority was allocated to each member. They had their own team name and password so it was their own problem if they forgot to sign out! I also noted that my nominated deputy would have taken great pleasure in stitching up my team by making excessive transfers and buying players who were injured.

 Internal Communication (Clause 5.5) was based on quantity rather than quality especially after watching football for 5 hours in the bar. Follow up on performance was regularly conducted via forums and e-mails although clearly the League Internal Auditor had his work cut out here.

Management Review (Clause 5.6) was conducted at the end of the each month when a Manager of the Month was nominated and then the end of the season where team awards were given out.

 Resources (Clause 6.1) Cash and Management Time to collect cash, Design and Development (Clause 7.3.2 -7.3.7) set up of the League, Training (Clause 6.2) How to use the Fantasy Football website, Infrastructure (Clause 6.3) Bar computer and Work Environment (Clause 6.4) Bar again! were all provided to ensure the League ran smoothly.

 Purchasing (Clause 7.4) was the easiest of chores thanks to Budweiser’s free website and a little of our management resource.

Production (Clause7.5.1) Seemed to be the difficult part: How has Downing missed a penalty again? (and why did I leave him in my team?), Why did I chose Ronaldo as captain the week Ferguson decides to give him a rest?, and why has O’Neil taken Knight off after 59 minutes, surely he knows I’ve got him in my defence?

 Identification and Traceability (Clause 7.5.3) was straight forward, everyone’s performance was available to all at the touch of a button you could see disastrous transfers, silly nominations as captains etc.

Customer Property (Clause 7.5.4) (Cash) was held and managed by the League nominated Management Representative.

 Calibration (Clause 7.6) and verification of measuring equipment were provided by OPTA statistics as these were the approved International standard.

 Monitoring and Measurement (Clause 8.2) and Analysis of Data (Clause 8.4) was carried out weekly after each set of games, when each player would seek some improvement by taking preventative or corrective action the following week.

Non-conforming product (Clause 8.3) was dealt with by immediate transfer out and the purchase of a more consistent goal scoring product.

 Customer Satisfaction (Clause 8.2.1) was apparent at the end of the season when the prizes were given out. If only it was as easy to get the cash off them at the start!