ISO 9001:2015 に準拠した酪農場 (潜在的顧客による) の第二者監査中に、監査人は搾乳場の毎日の生産量に大きなばらつきがあることを確認しました。唯一の顧客との現在の契約では、1 日あたり 2,000 リットルの供給となっています。しかし、過去 2 年間で、毎日の生産量のばらつきが増大していることに気付きました。
生産量が2,000リットル未満の場合は、供給しなかった1リットルにつき1.5ペソの罰金が科せられる。生産量が2,000リットルを超える場合は、余った牛乳を豚の餌として使う。
このプロセスは数十年にわたって行われてきました。この酪農場は、確立された慣行を変えたくないと考えていた現在の所有者の祖父によって設立されました。
監査人は、プロセスが管理されていないことを理由に不適合を報告します (条項 8.1)。
あなたが監査人であった場合、次のどの行動を受け入れますか?
正解：B
The action that the auditor would have accepted is:
*Option B: Apply the existing process of addressing the risks and opportunities of milk production. This option is correct because ISO 9001:2015 clause 8.1 requires the organization to plan, implement and control the processes needed to meet the requirements for the provision of products and services, and to implement actions determined in clause 6.1, which refers to the actions to address risks and opportunities. The organization should apply the existing process of addressing the risks and opportunities of milk production, which may include identifying the sources of variability, assessing the potential impacts and consequences, determining and implementing appropriate actions to reduce or eliminate the variability, monitoring and measuring the effectiveness of the actions, and reviewing and updating the actions as necessary.
The following options are not correct:
*Option A: Modify the contract with the current customer to provide them with only 1,500 litres of milk per day and make an agreement with a second customer. This option is not correct because it does not address the root cause of the variability in the daily production of the milking yard, which may affect the quality and consistency of the products and services provided by the organization. It also does not demonstrate the organization's commitment to meet the customer and applicable statutory and regulatory requirements, as required by ISO 9001:2015 clause 8.2.2.
*Option C: Retain the current contract and try to sell the occasional surplus milk to a second customer. This option is not correct because it does not address the root cause of the variability in the daily production of the milking yard, which may affect the quality and consistency of the products and services provided by the organization. It also does not demonstrate the organization's commitment to meet the customer and applicable statutory and regulatory requirements, as required by ISO 9001:2015 clause 8.2.2.
*Option D: Analyse the daily dispatch of milk for 7 days to determine its variability. This option is not correct because it does not address the root cause of the variability in the daily production of the milking yard, which may affect the quality and consistency of the products and services provided by the organization. It also does not demonstrate the organization's commitment to implement actions to address risks and opportunities, as required by ISO 9001:2015 clause 8.1.
References:
*ISO 9001:2015 Quality management systems - Requirements, Clause 8: Operation, Subclause 8.1:
Operational planning and control, Subclause 8.2: Requirements for products and services
*ISO 9001 Lead Auditor Course Material, Module 4: ISO 9001:2015 Requirements, Slide 23: Clause 8 - Operation
*ISO 9001 Lead Auditor Training Course - IRCA Certified, Section 4.2: ISO 9001:2015 Requirements, Subsection 4.2.8: Clause 8 - Operation
*Lead Auditor Exam Preparation Guide (EPG) Template - PECB, Section 3.2: Exam Content Outline, Subsection 3.2.1: Section 1 - Audit Fundamentals, Subsection 3.2.2: Section 2 - Audit Principles, Subsection
3.2.3: Section 3 - Audit Process, Subsection 3.2.4: Section 4 - Audit Competencies
