Risk assessment in Clause 5.3, Risk Assessment and Management.

[튜터 유문종]

API Spec. Q1 9th edition covers the subject of risk assessment in Clause 5.3, Risk Assessment and Management.

Risk assessment pertains to product delivery and product quality.

It is the responsibility of management to ensure risk assessments are carried out to meet the conformities that is stated through Q1.

Although Q1 indicates the requirements it does not give any specifics on how the organization should implement and set-up risk assessments.

When delving into Q1 to achieve risk assessment you need to read all the aspects of the different clauses that depicts the attributes related to risk assessment.

It doesn’t just start and stop with Clause 5.3. 

There are many areas that have information that allows for more understanding.

Consider risk assessment more of a Gap Analysis whereas it makes it circle through its relationship with other clauses as shown below. 

3.1.19 Defines Risk as Situation or circumstances that has both the likelihood of occurring and a potentially negative consequence.

5.2 (d) Planning – contingencies based on risk assessments.

5.4.2 (g) Design and Development Inputs results and risk assessments.

5.5 Contingency Planning – General – Organization shall maintain a documented procedure for contingency planning needed to address risk and contingency planning shall be based on assessed risk.

5.5.2 (a) Planning Output – at a minimum contingency plan shall include action required in response to significant risk scenarios

5.7.8 Note – preventative maintenance can be based on risk

5.11 Management of Change (MOC) General – the organization shall identify the potential risk

6.5.2 (f) Inputs for Management Review – Results of risk assessment

위험성 평가를 Gap Analysis보다 더 고려하는 반면 아래 표시된 것처럼 다른 절과의 관계를 순환시킵니다.
3.1.19 위험성은 발생할 가능성과 잠재적으로 부정적인 결과가 모두 있는 상황 또는 상황으로 정의합니다.
5.2 (d) 계획 – 위험 평가에 기반한 우발사태.
5.4.2 (g) 설계 및 개발 결과 및 위험성 평가를 입력합니다.
5.5 우발기획 – 일반 – 조직은 위험을 해결하는 데 필요한 우발기획을 위한 문서화된 절차를 유지 관리해야 하며 우발기획은 평가된 위험을 기반으로 해야 합니다.
5.5.2 (a) 기획 산출물 – 최소한의 우발계획에는 중대한 위험 시나리오에 대응하여 필요한 조치가 포함되어야 합니다.
5.7.8 참고 – 예방보전은 위험성을 기반으로 할 수 있습니다.
5.11 변경 관리(MOC) 일반 – 조직은 잠재적 위험을 식별해야 합니다.
6.5.2 (f) 경영 검토를 위한 입력 – 위험성 평가 결과

As stated in previous publication, understanding ISO9001:2015, ISO 31000, Risk Management gives additional insight towards guidelines.

 Keep in mind Risk Assessments is thinking, reviewing the potential possibility of a risk occurring.

You do this mindfully for everything you do or perform.

When you walk across the street your mind automatically assesses the situation before doing it by looking both ways.

If you see an automobile coming up the road your mind assesses the distance and your thoughts are, can you walk across safely before the automobile gets to close. You stop a potential problem from occurring when your assessment figures it’s better to wait until the automobile passes you by before attempting to walk.

In the example above, this is nothing more than what has been occurring during as auditors we see a potential problem under a Preventative Action (PA).

The occurrences are still PA’s just drilled down deeper to get to the possible root problem under risk assessments, before a major issue occurs and a non-conformance is noted. Creating the same mindset throughout the Quality Management System the same way your mindset has been created personally will aid in maintaining a better Quality Management System with regards to Quality and Safety meeting the potential possibilities long before they become problems.