Quality management system Flashcards
What is quality?
a. It is a characteristic of a product to satisfy the customer requirement and to function what it was intended to do consistently as well as meeting the regulatory requirement.
b. Quality is meeting the customer requirements , and legal and regulatory requirements consistently and repeatedly
Ans: Customer requirements are providing
What is customer requirement?
What is Quality Management?
Quality management refers to Managing activities and resources of an organisation to achieve objectives and prevent non-conformances.
What is compliances?
a. The state of an organisation processes and procedures that meets prescribed regulations.
Compliance is what is required from an organization based on local state and federal laws.
What is conformance?
a. An affirmative indication that a product or services has met the requirements of a relevant specification and regulation.
Conformance is what a company commits itself to (formally or informally)
- What is QMS?
QMS aims to improve FAA business processes in order to provide airworthy aircraft safely and efficiently and it is system that documents the structure, roles, accountability, responsibility, processes, procedures to achieve aviation capability.
QMS is system that details overall management activities to document quality policy, objectives and responsibilities and accountabilities to achieve organisational outcome.
DASR- All activities of the overall management function that determine the quality policy, objectives and responsibilities, and implement them by means such as quality planning, quality controls, quality assurance and quality improvement.
It is a system that documents the structure,
processes, roles, responsibilities, accountabilities and procedures required to achieve Organisational outcome.
QMS helps coordinate and direct a organisation’s activities to meet customer and regulatory requirement, and improve its effectiveness and efficiency on a continuous basis.
a. It is about ensuring airworthiness through assuring that our processes and procedures complies with DASR to provide aviation capability outcome to a level of a risk that can be eliminated SFARP if not possible minimised SFARP as well as providing continuous improvement activity through PDCA.
b. The delivery of a product or services that complies with DASR and ICA as well as continuously improving the system to provide aviation capability to a level of risk that can be eliminated SFARP if not minimised SFARP
- How do we do QMS in FAA?
a. We do it by using plan, do, check, act cycle.
- What is planning?
It is about personnel from QO, FavEng and AWOP identifying what processes lead to quality by creating document that defines a quality goals, resources and procedures.
It is the process of making plans to achieve quality goals.
Planning is about bring the quality standard back to the benchmark by creating a documents that defines a quality goals, resources and procedures.
Planning is about bring the quality standard back to the benchmark by creating a document that defines organisational key issues using risk-based decision by assessing likelihood and serverity,a chart of roles and responsibilities of who is going to manage quality system and how much resources is required and what processes and procedures are we going to use.
a. It is a continuous improvement activity led by unit command, members of unit QO, CAS and HQ-FAA policy sections. Identifying what process lead to quality
b. Planning involves:
i. The objectives and processes of system
ii. Resources required to deliver objectives
iii. Identifications of risks and opportunities
- What is doing?
Doing is about personnel are doing their job iaw Policy and procedures.
It is about conforming to such standards
a. Personnel completing their task by conforming to hierarchy of instructions
- What is checking?
It is to monitor and measure difference in what was observed against what was expected and reporting results
a. It is about monitoring and measuring process, internal audit process and management review process, against policies and objectives respectively. what you need to think about is what data you are going to collect, what data will used to monitor and measuring your process. You also need to understand internal audit program and how you are going to set it what are the process and these are the area we need to focus. who in the management team wil be getting together to look at all of these data and understand all of the element of management system. They will provide priority and corrective action.
It is about what data will be used to assess
Looking for an improvement in our processes by using PSOE
- What is present?
a. There is evidence that procedures is used and documented within the organisation management system
- What is suitability?
a. Is it good for what it is needed to do?
- What is operating?
a. People are using it and output is being produced
- What is effective?
a. Whether the final product or service meet the objective outcome
- What is acting?
It is about acting professionally on these
opportunities.
It is about taking actions from the findings of checking to improve the performance.
Are there issue reoccuring? who is going to involve? Set SMART target.
a. It is a process of taking actions to improve performance, when identified. We use 5 discrete steps in acting.
i. Risk or opportunity – non-formance, safety incidient, MRC, DATA trending, feedback
ii. Investigation – root cause analysis, context development
iii. Decide on action – leadership decide how to proceed to enhance or maintain quality.
iv. Change management – implement and educate changes
v. Review – verify the corrective action or improvement met objectives
vi. RIDCR
- What are the findings?
a. Level 1- Issued for a significant non-compliance or non-conformance with regulatory or safety requirements
which lowers the safety standard and seriously hazards flight safety.
b. Level 2 – Issued for a non-compliance or non-conformance with regulatory and/or safety requirements and
standards which lowers the safety standard and possibly hazards safety of flight; or, Nonconformance with requirements and standards, which may lower the ability to deliver organisational
capability outputs. 3months
c. Level 3 – as agreed Where it has been identified, by objective evidence, to contain potential problems that could lower
the safety standard and possibly hazards flight safety; or, a single or isolated example of a system or process failure.
Observations do not require causal analysis, however if left unaddressed may result in subsequent
elevation to a Level 2 Finding.
d. Opportunity for improvement - Where identified during the audit, the audit team may offer suggestions for improvement to FAA processes that enhance aviation capability or safety. OFI support continuous improvement of the QMS within the organisation, and may be provided to unit Command for consideration.
e. notes - Where it has been identified, by subjective evidence (or not enough objective evidence to make a
determination), to contain potential problems that could lower the safety standard and possibly
hazards flight safety.