IATF16949(ISO9001) {6.2} Quality Objectives and Planning to achieve them

IATF16949(ISO9001) {6.2} Quality Objectives and Planning to achieve them

See ISO 9001:2015 requirements.

6.2.1

The organization shall establish quality objectives at relevant functions, levels and processes needed for the quality management system.

The quality objectives shall:

a) be consistent with the quality policy;

b) be measurable;

c) take into account applicable requirements"

d) be relevant to conformity of products and services and to enhancement of customer satisfaction;

e) be monitored;

f) be communicated;

g) be updated as appropriate

The organization shall maintain documented information on the quality objectives.

6.2.2

When planning how to achieve its quality objectives, the organization shall determine:

a) what will be done;

b) what resources will be required;

c) who will be responsible;

d) when it will be completed;

 e) how the results will be evaluated

6.2.2.1 Quality objectives and planning to achieve them — supplemental

Top management shall ensure that quality objectives to meet customer requirements are defined, established, and maintained for relevant functions, processes, and levels throughout the organization.
The results of the organization’s review regarding interested parties and their relevant requirements shall be
considered when the organization establishes its annual (at a minimum) quality objectives and related performance
targets (internal and external). 

Explanation - Quality Objectives/Key Performance Indicator can be defined and implemented as per below Procedure 

KPI / QUALITY OBJECTIVE MONITORING PROCEDURE 

Define Quality Objectives/ KPI for Process effectiveness and efficiency monitoring for all department.

Define monitoring frequency based on previous performance, current status, customer feedback, etc.

Collect the data for decided KPI & objectives from previous MIS & daily monitoring record, Assign responsibility & benchmarking for process performance in form of KPI & objective along with timeline.

  

Plan the activities how to achieve its quality objectives & KPI’s.

Determine the following & make action plan :

a) what will be done;

b) what resources will be required;

c) who will be responsible;

d) when it will be completed;

e) how the results will be evaluated.

Monitor the KPI & objectives as per decided frequency against set targets.

 Communicate the status of monitoring of quality objectives & KPI’s to top management on monthly basis.

Prepare the action plan on non achieved objective with root cause analysis.

Submit the decided action to Management Representative with action target date & responsibility for management review meeting discussions. 

Quality Objective Target will be revised to 2-5% more or less than previous target if all target are achieved in last six month.

If target is not achieved then Target will remain same. 

Top Management / Management Representative will decide the target during MRM Review depending on quality objective indicators.

MANAGEMENT REVIEW MEETING (MRM)

MANAGEMENT REVIEW MEETING (MRM)

Organize the Management review meeting once in six months or three months if IATF 16949:2016 Standard is recently implemented.

  

Send the intimation note including the agenda points of Management Review Meeting (MRM) to all DH, DIRECTOR, CMD, stating the date, time and venue at least 7 to 10 days in advance.

Conduct discussions with concerned departmental head and collect backup data and the details.

Conduct the Management Review meeting as scheduled. 

The Chair person for the meeting shall be the CMD and in his absence, the DIRECTOR will be chair person.

The minutes of the meeting are noted the salient points discussed and actions to be taken and identifying the responsibility and target date for each activity.

The backup information is stored in the Server records as Annexures to the minutes.

The minutes of the meeting in the on line file is shared with all concerned participants.

Monitor the proposed actions agreed by individuals, on the target dates for their progress/completion. 

Follow up the actions in the next MRM.

INTERNAL SYSTEM AUDIT

INTERNAL SYSTEM AUDIT

Prepare a list of trained internal auditors identifying Training details and department. 

 

Prepare an annual audit plan at the beginning of each financial year.

Conduct Internal Audit at frequency of once in Six months as planned in Annual Audit Plan. 

Plan the audit in such a way that all the shifts are audited at the scheduled frequency.

In case if Management Representative finds more NC than usual in internal / external audit, frequency of audit can be increased for the department based on Management Representative decision.

Update the annual audit plan.

Prepare a schedule for internal audit identifying the auditors, clauses, date, time and issue to all departments before min 10 days of audit through email / display board.

Fill the audit observation sheet Covering all the details observed (compliance and non-compliances) and all clauses audited. 

Ensure by reviewing the audit observation sheet whether auditors covered all Applicable clauses and Sign the audit observation sheet.

During audit, all NC points of  last audit shall also be verified.

Complete the Non-conformity reports identifying appropriate clause of IATF 16949:2016 standard and the objective evidence.

Send the NCR’s to the auditee and receive proposed disposition and corrective actions with target date from auditee within 7 days of audit.

Countermeasures shall be taken within 30 days of NC raising.

If more time is required for NC Closure, approval to be taken from Top Management.

Prepare a summary of the Internal Audit conducted identifying clause wise and department-wise breakup of NCR’s. 

Close the NCR’s based on satisfactory completion of actions proposed and verification of objective evidences on target date agreed by the auditee.

Discuss the closure of NCR’s in the Management Review Meetings.

IDENTIFICATION OF RISKS AND OPPORTUNITIES

IDENTIFICATION OF RISKS AND OPPORTUNITIES 

Identify external & internal issues which are relevant to purpose of strategic direction of the organization.

Consider internal & external issues to enhance desirable effects & give assurance to achieve the intended result of Quality Management System.

Determine the risk and opportunities need to be addressed to

To give assurance that the quality management system can achieve its intended results;

Enhance desirable effects

Prevent, or reduce, undesired effects

achieve improvement  

Prepare Risk Analysis Sheet to prevent undesired effect & to achieve continual improvement of the QMS. 

Review the Risk Analysis Sheet as per Process Risk Analysis Review Plan at six-month frequency.

After analysis of risk identify opportunities associated in respective process, identify the controls required to reduce the risk.

Take appropriate action to reduce risk and for identified opportunities. 

When planning these actions, shall consider its technological options and its financial, operational and business requirements

Discuss the action taken to reduce the risk and addressed opportunities and effectiveness of action taken in every MRM.

ENERGY MANAGEMENT

ENERGY MANAGEMENT 

The Internal energy audit Plan defines the Frequency of the internal energy audit. 

Internal energy audit check sheet includes general checkpoint that helps identify energy waste and identify opportunities for improving energy practices in various departments / areas.

Internal energy audit Report includes verification, monitoring and analysis of use of energy which including submission of technical report containing recommendations for improving energy efficiency with cost benefit analysis and an action plan to reduce energy consumption.

MACHINE BREAKDOWN MAINTENANCE AND ANALYSIS

MACHINE BREAKDOWN MAINTENANCE AND ANALYSIS 

In case of any equipment breakdown, make sure that the equipment user dept raises a machine breakdown memo to the concern maintenance team.

Supervisor/operators shall inform Maintenance In-charge about the Breakdown through Machine Breakdown Memo. 

Maintenance in-charge will allocate internal technician / external agency personnel depending on nature of breakdown based on information provided by supervisor / operator.

Maintenance technician will monitor the breakdown maintenance activities and record the same in Breakdown maintenance register. 

Corrective actions will be taken as appropriate by Maintenance In-charge with need based guidance of Top Management/other personnel and recorded in Corrective action Report 

Analysis is carried out on not meeting targets.

Maintenance technician reviews the effectiveness of breakdown maintenance by checking the working of machine and only after positive confirmation hands over the machine to respective department through endorsement in the breakdown maintenance register. 

Follow same process for Poka-Yoke Breakdown but record in separate register.

The root cause analysis is to be done monthly basis on top one major breakdowns, Repetitive Breakdown of same nature & cause and Poka-Yoke Failure. 

Corrective Action is to be taken on the basic of analysis.

The machine history card is accordingly updated.

 Machine down-time recorded in breakdown maintenance register is also entered in the system for enabling of calculation of Overall equipment effectiveness as well as machine utilization data.

Calculate the MTTR (Mean Time To Repair) & MTBR (Mean Time Between Failures) with considering all the events occurs. 

 Record the details in MTTR /MTBF Monitoring Sheet and analysis done on not meeting targets.

During break down repair if machine is not repairable by in-house or by external agency then machine scrap card is to be filled by Maintenance Head. 

After taking approval from Top Management ,machine is to be scrapped/disposed and list of scrap machine is to be updated.

PREDICTIVE MAINTENANCE OF MACHINE

PREDICTIVE MAINTENANCE OF MACHINE

The data contained in Preventive maintenance register, Breakdown maintenance register and statistical control charts are utilized to estimate life of parts /components which are prone to wear and tear.

Accordingly, detection /prediction of future potential failures are made.

The detail of predictive maintenance carried out is recorded in the Predictive Maintenance Register.

Any changes resulting in preventive maintenance schedule due to predictive maintenance activity results are accordingly incorporated in the preventive maintenance schedule.