What is Quality Control?

<!–[CDATA[

What is Quality Control?

As we explained last time, quality control is “a system of means for economically producing goods or services of quality that meet the customer’s requirements.”
In other words, it controls the quality, cost, and delivery of goods and services provided to customers to meet their requirements.
It is important that each workplace or department can provide goods and services more cheaply, quickly, and efficiently than other companies.
To do this, it is necessary to implement not only proprietary technology but also management technology using statistics throughout the company.

Quality Control (QC), Quality Assurance (QA), and Audit are different.

By nature, quality assurance should be performed by the relevant department itself. No other department or person can assure quality on behalf of the department in question. There are many cases of confusion between quality control (QC), quality assurance (QA) and audit.

QC is an activity that controls quality on its own. QA is to be deeply involved in the process and to continue the work while assuring quality from a third-party perspective, The QA person should be experienced in the process and should be familiar with the work in question. The QA expert provides third-party guidance and advice on the process, while assuring (endorsing) the quality of the deliverables, etc.
The reason for the third-party nature is that the event must be judged objectively and must not lack appropriateness, for example, by becoming familiar with the person in charge of the implementation.
The QA person does not have to be in a separate department and can be affiliated with the department in question.
QA personnel are also accountable to customers and regulators. Therefore, they will inevitably monitor and oversee the process under strict scrutiny.
An audit, on the other hand, is a periodic or irregular spot check of processes and deliverables by an independent department. In other words, the audit is after-the-fact.
The misconception that quality assurance is about auditing must be dispelled.
Often, people mistakenly believe that quality assurance is complete when the audit is completed. Yet, when there is a complaint, they claim that the audit is responsible, as if it were someone else’s fault.
It is important to note that audits are one but not all quality assurance activities. It should be noted that the quality assurance department is also the audited department.

What is QC?

QC stands for Quality Control. Then, in your company’s QC, are you really controlling things, or are you only repeatedly checking? If QC is a checking activity, it should be called Quality Check.
So what exactly is Control? Control is the activity of returning a process that is about to deviate (deviate) from the standard to the standard.
For example, in baseball, a pitcher controls his pitches by targeting the strike zone. Similarly, QC controls the process by targeting the strike zone of quality. Then, where is the quality standard (strike zone) described in the standard operating procedure (SOP)?

QC Case Study 1.

Suppose a subcontractor is asked to perform data entry for 1,000 pieces of data. In the contract, the subcontractor “promised” to allow up to 0.3% errors in the acceptance test and that the data would pass acceptance inspection. However, when we started checking the data at acceptance inspection, we found one, two, three, four, etc. In this case, the number of errors was 0.3%. In this case, since the errors exceeded 0.3%, the item cannot be accepted and will be returned to the vendor in question. At that point, they would tell the vendor, “The quality is poor (does not meet the customer’s requirements), so quality assurance must be performed again before the product can be delivered again.” They will tell you that the quality is poor (does not meet the customer’s requirements).
Importantly, do not tell them where the errors were. Also, do not tell them how many errors there were. If you tell them where the errors are, they will correct only those errors and re-deliver. If you tell them how many errors there were, they will correct the number of errors and re-deliver. In general, the dilemma is that correcting at a later stage in the process does not improve the quality of the data.

QC Case Study 2.

Let’s say that in a cookie factory, the production instructions state that the cookies are to be baked at 170°C ±5°C. The production manager will reduce the heat of the burner if the temperature is about to exceed 175°C. If it goes below 165°C, he will increase the heat. If the temperature is about to drop below 165°C, he will increase the heat. This is because above 175°C, the product will burn, and below 165°C, the product will be semi-cooked. Baking at 170°C ±5°C, as stated in the production instructions, will produce delicious cookies according to the predetermined specifications and quality.

What is “SOP”?

SOP stands for “Standard Operation Procedure. Here, “standard” refers to the strike zone in baseball.
In Japan, it is often the case that SOPs are changed because of aversion to SOP violations and deviations. SOPs should not be easily changed. If the strike zone changes on a daily basis, then the quality control and quality assurance of yesterday will be meaningless.
There is also a tendency to try to include everything, including exceptions, in SOPs. However, if the strike zone is expanded without limit, a pitch will be a strike no matter where it is thrown. In other words, there would be no control. If you write anything in the SOP, including exceptions, it is not a standard but just an “OP”.

Correct Exception Handling.

However, exceptions are bound to occur. If an exception is necessary, how should it be handled? The correct way to handle an exception is, for example, to describe the reasons why the SOP cannot be complied with in advance in a written plan, etc., and to have it reviewed and agreed upon by a third party QA person.
The reason for this is called Justification. The QA staff must agree on the Justification, endorse it, and then the responsible person must approve the plan.

related product

[blogcard url=https://xn--2lwu4a.jp/qms-rx/ title=”QMS（手順書）ひな形　医薬品関連” ] [blogcard url=https://xn--2lwu4a.jp/qms-md/ title=”QMS（手順書）ひな形　医療機器関連” ] [blogcard url= https://ecompliance.co.jp/SHOP/EL-112.html title=”【セミナービデオ】【医薬品】プロセスバリデーションの具体的な計画書・記録書・報告書の作成セミナー”] [blogcard url= https://ecompliance.co.jp/SHOP/EL-102.html title=”【セミナービデオ】【医療機器】プロセスバリデーションの具体的な計画書・記録書・報告書の作成セミナー”] [blogcard url= https://ecompliance.co.jp/SHOP/P166_EB051a.html title=”【書籍】 【改正GMP省令対応シリーズ2】 改正GMP省令で要求される 『医薬品品質システム』と継続的改善”] [blogcard url= https://ecompliance.co.jp/SHOP/O067.html title=”【VOD】改正GMPセミナーシリーズ　品質リスクマネジメント編”]

]]>