Digital Manufacturing Process Audit Checklist
Identify and eradicate inefficiencies and issues in the manufacturing process
Published March 26th, 2020
What is a Manufacturing Process?
A manufacturing process is a set of principles, protocols, and steps set and followed by manufacturing operations when using raw materials to produce their final products. Manufacturing processes vary, depending mainly on the nature and size of the operation, as well as organizational preference.
This article features: 1) what a manufacturing process audit checklist is; 2) common manufacturing process mistakes and how to prevent them; and 3) free, ready-to-use templates to help make manufacturing process audits easy and hassle-free.
What is a Manufacturing Process Audit Checklist?
This type of checklist is mainly used by manufacturing plant managers and compliance officers to help ensure that legal and organizational standards are being met by the operation. A typical audit would include a walkthrough of the site to check if workers are following set protocols and best practices designed to ensure consistent, high-quality output.
Common Manufacturing Mistakes and How to Prevent Them
A manufacturing plant has many interdependent moving parts that must function efficiently. A mistake, an inefficient process, or malfunction, even in just one area, will negatively affect the entire production line. Here are some of the most common manufacturing mistakes and some tips on how to prevent them:
- Not having a regular inspection schedule
Management should implement regular inspections of the manufacturing process and manufacturing floor itself to ensure that everything is being run as designed and agreed upon. This is also done to ensure that the necessary equipment, facilities, PPE’s, and everything else workers need to do their jobs properly are available. An effective inspection app can assist plant managers and compliance officers in assessing performance, facilities, and task assignments.
- Ineffective documentation of data, defects, malfunctions, and non-compliance
Data-gathering can easily be overlooked if, on the surface, your operation is meeting the expected output targets. Good data documentation, however, is essential to knowing the areas where the operation is succeeding and where improvements can be made. Incidents such as identified defects, malfunctions, and non-compliance must be reported immediately and properly documented so the problem can be contained as long-term solutions are formulated and eventually implemented.
- Picking the wrong contract manufacturing organization (CMO) when outsourcing
Complete or partial outsourcing of manufacturing is a popular way to cut costs, and a variety of high-earning industries including technology and pharmaceuticals have long enjoyed its benefits. To successfully outsource, however, requires top management to study, compare, and audit different CMOs to assess if their facilities, capabilities, and experience are a good fit for your product.
- Lack of accountability
Clear accountability improves the overall manufacturing process because workers are compelled to be more meticulous when non-compliance can be traced back to them. Ensure that there are official personnel accountable for certain equipment, stages of production, and outputs. By having a point of contact for different manufacturing aspects, information is shared faster and communication becomes easier. A fair system of accountability lowers the chances of human error and neglect that negatively affects production.
Mobile App for Manufacturing Process Audits
Collecting, organizing, and documenting paper audits consume time, energy, and space—three resources that can be utilized better by downloading iAuditor, the world’s #1 mobile inspection app. Used for more than 50 million inspections in over 80 countries, iAuditor has been revolutionizing safety and quality for a variety of industries with its versatile features and user-friendly interface. With iAuditor, you can:
- Download ready-to-use manufacturing process audit checklists or easily create and customize your own via Smart Forms.
- Perform inspections on your mobile phone or tablet anytime, anywhere, even if you’re offline. Your data will automatically sync to the cloud once you connect to the internet.
- Take photos of non-compliance, defects, and malfunctions and annotate them for added clarity.
- Identify issues and assign corrective actions to immediately address the problem. Set the time, date, and priority level to triage tasks.
- Automatically generate reports after completing your inspection and easily share with management and personnel.
- Track your inspection frequency and performance via data analytics and gain actionable insights to improve operations.
- Integrate iAuditor with business intelligence (BI) tools to gain additional insights and visualize your data .
Free Manufacturing Process Audit Checklists
Manufacturing Process Audit Checklist
Manufacturing plant managers and compliance officers can use this manufacturing process audit checklist to ensure that workers adhere to quality and safety standards set by the organization. Check if employees are all wearing the appropriate PPEs for their tasks, the right materials and tools for work are available, and if the agreed upon process is being followed as designed and approved by management.
Manufacturing Quality Control Checklist
Plant managers and compliance officers can use this checklist for weekly quality control inspections to maintain quality standards across the whole operation. It can be used for the random inspection of finished products to identify defects and non-compliance.
Manufacturing SOP Compliance Template Checklist
A manufacturing SOP Compliance Template is used to ensure that workers follow the prescribed SOPs for operations. It can be used by plant operations managers when performing walkthrough inspections to verify worker compliance and note noncompliance.
Standard Operating Procedure Checklist (Food Manufacturing)
Similar to the housekeeping SOP mentioned above, this food manufacturing SOP template can be used to evaluate if workers adhere to standard food manufacturing protocols such as handwashing, cleaning and sanitizing food contact surfaces before proceeding with the food production process. This can also guide workers to prevent unintended omissions and ensure product quality.
General GMP Checklist
This General GMP Compliance Checklist can be used during regular site inspections to evaluate overall adherence to manufacturing protocols. The checklist is divided into 9 sections and applies scoring which will give you insight into how your audits are performing over time. The checklist also includes quality management processes for contamination, pest control, packaging, and labelling. Lastly, the checklist assesses if your workers receive adequate training to carry out their tasks. Conduct GMP audits with this checklist using iAuditor on your mobile or tablet, capture photo evidence of non-compliance and assign corrective action items for immediate resolution.